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A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP)

Primary Purpose

Biochemically Recurrent Prostate Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Darolutamide (BAY1841788, Nubeqa)
Placebo matching darolutamide
ADT
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biochemically Recurrent Prostate Cancer focused on measuring darolutamide, high risk BCR, PSMA PET imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol. Male ≥18 years of age at the time of signing the informed consent. Histologically or cytologically confirmed adenocarcinoma of prostate. Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit (or refused) for ART or SRT, or primary radiotherapy (RT). High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted). Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer. Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local or central values accepted). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10^9/L. Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert's disease); Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula. Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period. Exclusion Criteria: Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate. History of bilateral orchiectomy. Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening. Brain metastasis on PSMA PET /CT by BICR at screening. High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy. Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study. Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF. Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization. Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF. Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years. History of pelvic radiotherapy for other malignancy.

Sites / Locations

  • Mayo Clinic Hospital
  • Arizona Institute of Urology
  • City of Hope National Medical CenterRecruiting
  • University of Southern California
  • Tower Urology, IncRecruiting
  • University of California, Los Angeles
  • University of California Irvine Medical Center
  • UCSF Med Center Helen Diller Family Comp Cancer Center
  • Colorado Urology (Colorado Clinical Research)Recruiting
  • Clermont Oncology Center
  • University of Florida - Jacksonville
  • Mid Florida Cancer Centers
  • Northwestern University Feinberg School of Medicine
  • Jesse Brown VA Medical Center
  • Comprehensive Cancer Center
  • Urology of Indiana, LLC
  • First Urology PSC
  • University of Kansas
  • Chesapeake Urology Associates
  • Johns Hopkins Univ School Med|Sidney Kimmel Comp Cancer Cntr
  • Dana-Farber Cancer Institute
  • UMass Memorial Medical Center - University Campus
  • Barbara Ann Karmanos Cancer Institute - Detroit
  • Michigan Institute of Urology, PC
  • University of Minnesota Medical Center
  • Washington University School of Medicine
  • Urology Cancer Center, PC
  • New Jersey Urology (NJU)
  • New Jersey Urology, LLC
  • NYU Langone Health
  • Associated Medical Professionals of NY, PLLC
  • White Plains Hospital
  • Alliance UrologyRecruiting
  • Wake Forest Baptist Health
  • The Urology Group
  • Ohio State University Wexner Medical Center
  • MidLantic Urology
  • Urological Associates of Lancaster
  • Allegheny General Hospital
  • University of Pittsburgh
  • VA Pittsburgh Healthcare System
  • Bon Secours St. Francis Hospital
  • Carolina Urological Research Center
  • Urology Austin, PLLC (an affiliate of Urology America)
  • University of Texas MD Anderson Cancer Center
  • Urology San Antonio Research, PA
  • The Urology Place
  • Spokane Urology PS
  • Royal Prince Alfred Hospital
  • South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department
  • Macquarie University Hospital
  • GenesisCare Newcastle
  • Port Macquarie Base Hospital
  • St Vincents Hospital Sydney
  • Sydney Adventist Hospital
  • Westmead Hospital
  • Bundaberg Hospital, Genesis Cancer Care - Bundaberg
  • Wide Bay Hospital and Health Service - Hervey Bay Hospital
  • Tasman Health Care
  • Eastern Clinical Research Unit - Box Hill
  • Epworth HealthCare
  • Cabrini Medical Centre
  • Royal Melbourne Hospital
  • Austin Health
  • Prince of Wales Hospital NSW
  • Ordensklinikum Linz GmbH Elisabethinen
  • Medizinische Universität Innsbruck
  • Uniklinikum Salzburg - Landeskrankenhaus
  • Krankenhaus der Barmherzigen Brüder
  • Universitätsklinikum AKH Wien
  • Assistência Multidisciplinar em Oncologia (AMO)
  • Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
  • Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
  • Hospital Moinhos de Vento-Centro Clínico
  • Faculdade de Medicina do ABC
  • Instituto do Câncer do Estado de São Paulo
  • Inst. de Assistência Médica ao Sérvidor Público Estadual
  • Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
  • Hospital Sirio Libanes
  • Prostate Cancer Centre
  • Vancouver General Hospital
  • BCCA-Vancouver Island Centre
  • Nova Scotia Health Authority
  • Hamilton Health Sciences-Juravinski Cancer Centre
  • London Regional Cancer Program
  • Princess Margaret Cancer Centre - UHN
  • Hopital Hotel-Dieu de Levis
  • Sir Mortimer B. Davis Jewish General Hospital
  • Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont
  • Nanjing First Hospital
  • Fudan University Shanghai Cancer Center
  • The 1st Affiliated Hospital of Zhejiang University
  • Peking Union Medical College Hospital (PUMCH) - East Location
  • Aalborg University Hospital
  • Aarhus Universitetshospital
  • Rigshospitalet
  • Docrates Klinikka
  • HUS, Meilahden sairaala
  • Oulun yliopistollinen sairaala
  • Tampereen yliopistollinen sairaala, keskussairaala
  • Turun yliopistollinen keskussairaala
  • Hôpital Pellegrin - Bordeaux
  • Centre Jean Perrin
  • CHU GRENOBLE - Hopital Michallon
  • Hôpital Claude Huriez - Lille
  • Institut Curie - Ulm - Paris
  • Hopital Bichat - Paris
  • Centre Hospitalier Lyon Sud
  • Institut de Cancérologie Jean Godinot
  • Hôpital Pontchaillou
  • Institue Curie - Saint-Cloud
  • Institut de Cancérologie de l'Ouest - Saint Herblain
  • ICANS - Institut de Cancérologie de Strasbourg Europe
  • Hôpital Bretonneau
  • Institut Gustave Roussy - Département de Médecine Oncologique
  • Klinikum Mannheim GmbH
  • Studienpraxis Urologie
  • Klinikum rechts der Isar
  • Klinikum der Universität Würzburg
  • Universitätsklinikum der Johann Wolfgang Goethe Universität
  • Städtisches Klinikum Braunschweig gGmbH
  • Universitätsmedizin der Georg-August-Universität Göttingen
  • Universitätsklinikum Köln
  • Universitätsklinikum Münster (UKM)
  • Medizinische Fakultät der Otto-von-Guericke Universität
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Marien-Krankenhaus Bergisch Gladbach
  • Vivantes Klinikum Am Urban
  • Charité Campus Benjamin Franklin (CBF)
  • Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie
  • Rambam Health Corporation
  • Hadassah Hebrew University Hospital Ein Kerem
  • Shaare Zedek Medical Center
  • Clalit Health Services Rabin Medical Center-Beilinson Campus
  • Sheba Medical Center
  • Sourasky Medical Center
  • Istituto Nazionale Tumori IRCCS Fondazione G.Pascale
  • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • AUSL di Bologna
  • A.O.U. di Modena - Policlinico
  • AUSL-IRCCS di Reggio Emilia
  • IRCCS Centro di Riferimento Oncologico (CRO)
  • Fondazione PTV Policlinico Tor Vergata
  • IRCCS Istituti Fisioterapici Ospitalieri - IFO
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • ASST Papa Giovanni XXIII
  • Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
  • Ospedale San Raffaele s.r.l.
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Molinette Hospital University of Torino
  • A.O.U. Consorziale Policlinico
  • A.O.U. Ospedali Riuniti Foggia
  • Istituto Oncologico Veneto IRCCS (IOV)
  • IRCCS Ospedale Sacro Cuore Don Calabria
  • A.O.U.I. Verona
  • IRCCS Ist Nazionale Tumori GE - Oncologia Medica
  • A.O. di Perugia - Ospedale Santa Maria della Misericordia - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA
  • Santa Chiara Hospital
  • Hokkaido University Hospital
  • Kanazawa University Hospital
  • Yokohama City University Hospital
  • Osaka University Hospital
  • Tokyo Medical and Dental University Hospital
  • Kagoshima University Hospital
  • Kyoto University Hospital
  • Auckland City Hosptial
  • Canterbury Urology Research Trust
  • Tauranga Urology Research Limited
  • Centro Clinico Academico - Braga
  • IPO Lisboa
  • Hospital CUF Tejo
  • Fundacao Champalimaud
  • Hospital da Luz - Lisboa
  • Centro Hospitalar Universitário de Lisboa Norte | Heart and Vessels Department
  • Hospital Clínico Universitario de Santiago de Compostela
  • Hospital del Mar
  • Hospital Clínic i Provincial de Barcelona
  • Hospital Fundació Puigvert
  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Hospital Universitario Puerta del Mar
  • MD Anderson International Espanya, S.A.
  • Hospital Ramón y Cajal
  • Hospital Madrid Norte Sanchinarro
  • H. General Uiversitario Morales Meseguer - Department of Urology
  • Hospital Universitario Virgen de la Victoria | Cardiology Department
  • Virgen del Rocio University Hospital - Oncology Department
  • Instituto Valenciano de Oncología
  • Hospital Universitari i Politècnic La Fe
  • Goteborgs Universitet
  • Skane University Hospital - Department of Urology
  • Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)
  • Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru
  • Mount Vernon Cancer Centre
  • Royal Surrey County Hospital NHS Foundation Trust
  • University College London Hospitals NHS Foundation Trust
  • Royal Marsden Hospital (London)
  • Charing Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Darolutamide+ADT

Placebo+ADT

Arm Description

Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.

Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.

Outcomes

Primary Outcome Measures

Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)

Secondary Outcome Measures

Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
Time to Castration-resistant prostate cancer (CRPC) assessed by investigator
Time to initiation of first subsequent systemic antineoplastic therapy
Time to loco-regional progression by PSMA PET/CT
Time to first Symptomatic skeletal event (SSE)
Overall survival (OS)
Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)
Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score
FACT-P is a multidimension, selfreport QoL instrument specifically designed for patients with prostate cancer. It consists of 39 questions items, made up by 2 parts: the 27 questions for functional assessment of cancer therapy general (FACT-G) and 12 prostate cancer subscale questions. It assesses 4 main domains which are: physical (n=7), social/family (n=7), emotional (n=6) and functional wellbeing (n=7).
Time to symptomatic progression
Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity
Number of participants who discontinue study treatment due to a TEAE

Full Information

First Posted
March 21, 2023
Last Updated
September 26, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05794906
Brief Title
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
Acronym
ARASTEP
Official Title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
January 29, 2027 (Anticipated)
Study Completion Date
February 28, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: take blood and urine samples. measure PSA and testosterone levels in the blood samples do physical examinations check the participants' overall health examine heart health using electrocardiogram (ECG) check vital signs check cancer status using PSMA PET/CT scans, CT, MRI and bone scans take tumor samples (if required) ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biochemically Recurrent Prostate Cancer
Keywords
darolutamide, high risk BCR, PSMA PET imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Darolutamide+ADT
Arm Type
Experimental
Arm Description
Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.
Arm Title
Placebo+ADT
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.
Intervention Type
Drug
Intervention Name(s)
Darolutamide (BAY1841788, Nubeqa)
Intervention Description
Coated tablet, 300 mg / tablet, oral.
Intervention Type
Other
Intervention Name(s)
Placebo matching darolutamide
Intervention Description
Coated tablet, oral
Intervention Type
Other
Intervention Name(s)
ADT
Intervention Description
Luteinizing hormone-releasing hormone [LHRH] agonist/antagonists
Primary Outcome Measure Information:
Title
Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)
Time Frame
After randomization to after last treatment, approximately 24 months
Secondary Outcome Measure Information:
Title
Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
Time Frame
After randomization to after last treatment, approximately 46 months
Title
Time to Castration-resistant prostate cancer (CRPC) assessed by investigator
Time Frame
After randomization to after last treatment, approximately 46 months
Title
Time to initiation of first subsequent systemic antineoplastic therapy
Time Frame
After randomization to after last treatment, approximately 46 months
Title
Time to loco-regional progression by PSMA PET/CT
Time Frame
After randomization to after last treatment, approximately 46 months
Title
Time to first Symptomatic skeletal event (SSE)
Time Frame
After randomization to after last treatment, approximately 46 months
Title
Overall survival (OS)
Time Frame
After randomization to after last treatment, approximately 46 months
Title
Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)
Time Frame
After randomization to after last treatment, approximately 46 months
Title
Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score
Description
FACT-P is a multidimension, selfreport QoL instrument specifically designed for patients with prostate cancer. It consists of 39 questions items, made up by 2 parts: the 27 questions for functional assessment of cancer therapy general (FACT-G) and 12 prostate cancer subscale questions. It assesses 4 main domains which are: physical (n=7), social/family (n=7), emotional (n=6) and functional wellbeing (n=7).
Time Frame
After randomization to after last treatment, approximately 24 months
Title
Time to symptomatic progression
Time Frame
After randomization to after last treatment, approximately 46 months
Title
Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity
Time Frame
After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
Title
Number of participants who discontinue study treatment due to a TEAE
Time Frame
After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol. Male ≥18 years of age at the time of signing the informed consent. Histologically or cytologically confirmed adenocarcinoma of prostate. Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit (or refused) for ART or SRT, or primary radiotherapy (RT). High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted). Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer. Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local or central values accepted). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10^9/L. Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert's disease); Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula. Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period. Exclusion Criteria: Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate. History of bilateral orchiectomy. Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening. Brain metastasis on PSMA PET /CT by BICR at screening. High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy. Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study. Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF. Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization. Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF. Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years. History of pelvic radiotherapy for other malignancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayer Clinical Trials Contact
Phone
(+)1-888-84 22937
Email
clinical-trials-contact@bayer.com
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Arizona Institute of Urology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Tower Urology, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UCSF Med Center Helen Diller Family Comp Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Colorado Urology (Colorado Clinical Research)
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Name
Clermont Oncology Center
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Florida - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mid Florida Cancer Centers
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763-8316
Country
United States
Individual Site Status
Withdrawn
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Jesse Brown VA Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Urology of Indiana, LLC
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
First Urology PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Chesapeake Urology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Johns Hopkins Univ School Med|Sidney Kimmel Comp Cancer Cntr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6084
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UMass Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655-0002
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Barbara Ann Karmanos Cancer Institute - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Michigan Institute of Urology, PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Urology Cancer Center, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130-5606
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
New Jersey Urology (NJU)
City
Saddle Brook
State/Province
New Jersey
ZIP/Postal Code
07663-5227
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
New Jersey Urology, LLC
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Associated Medical Professionals of NY, PLLC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
White Plains Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Alliance Urology
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
MidLantic Urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Urological Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Individual Site Status
Withdrawn
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bon Secours St. Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Carolina Urological Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29579
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Urology Austin, PLLC (an affiliate of Urology America)
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Urology San Antonio Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The Urology Place
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78257
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Spokane Urology PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Macquarie University Hospital
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
GenesisCare Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Individual Site Status
Withdrawn
Facility Name
St Vincents Hospital Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Bundaberg Hospital, Genesis Cancer Care - Bundaberg
City
Bundaberg
State/Province
Queensland
ZIP/Postal Code
4670
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Wide Bay Hospital and Health Service - Hervey Bay Hospital
City
Pialba
State/Province
Queensland
ZIP/Postal Code
4655
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Tasman Health Care
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Eastern Clinical Research Unit - Box Hill
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Epworth HealthCare
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Cabrini Medical Centre
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Austin Health
City
Heidelberg
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Prince of Wales Hospital NSW
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Uniklinikum Salzburg - Landeskrankenhaus
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Wien
ZIP/Postal Code
1020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum AKH Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Assistência Multidisciplinar em Oncologia (AMO)
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950-640
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59062-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital Moinhos de Vento-Centro Clínico
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Instituto do Câncer do Estado de São Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Inst. de Assistência Médica ao Sérvidor Público Estadual
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital Sirio Libanes
City
Sao Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Prostate Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3Z6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
BCCA-Vancouver Island Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Princess Margaret Cancer Centre - UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Hopital Hotel-Dieu de Levis
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Jiangsu
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The 1st Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking Union Medical College Hospital (PUMCH) - East Location
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Aarhus Universitetshospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Docrates Klinikka
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Individual Site Status
Withdrawn
Facility Name
HUS, Meilahden sairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Oulun yliopistollinen sairaala
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Tampereen yliopistollinen sairaala, keskussairaala
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Turun yliopistollinen keskussairaala
City
Turku
ZIP/Postal Code
FIN-20521
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Pellegrin - Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Jean Perrin
City
Clermont-ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Not yet recruiting
Facility Name
CHU GRENOBLE - Hopital Michallon
City
Grenoble
ZIP/Postal Code
38048
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Claude Huriez - Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institut Curie - Ulm - Paris
City
PARIS cedex 5
ZIP/Postal Code
75248
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Bichat - Paris
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institut de Cancérologie Jean Godinot
City
Reims
ZIP/Postal Code
51726
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Pontchaillou
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institue Curie - Saint-Cloud
City
Saint-cloud
ZIP/Postal Code
92210
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institut de Cancérologie de l'Ouest - Saint Herblain
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Not yet recruiting
Facility Name
ICANS - Institut de Cancérologie de Strasbourg Europe
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institut Gustave Roussy - Département de Médecine Oncologique
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Mannheim GmbH
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Studienpraxis Urologie
City
Nürtingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72622
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum rechts der Isar
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum der Universität Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum der Johann Wolfgang Goethe Universität
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Städtisches Klinikum Braunschweig gGmbH
City
Braunschweig
State/Province
Niedersachsen
ZIP/Postal Code
38126
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsmedizin der Georg-August-Universität Göttingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Münster (UKM)
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Fakultät der Otto-von-Guericke Universität
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Marien-Krankenhaus Bergisch Gladbach
City
Bergisch Gladbach
ZIP/Postal Code
51465
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Vivantes Klinikum Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Charité Campus Benjamin Franklin (CBF)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Hadassah Hebrew University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9372212
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Clalit Health Services Rabin Medical Center-Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione G.Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. di Bologna Policlinico S.Orsola Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
AUSL di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. di Modena - Policlinico
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
AUSL-IRCCS di Reggio Emilia
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Centro di Riferimento Oncologico (CRO)
City
Pordenone
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Istituti Fisioterapici Ospitalieri - IFO
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale San Raffaele s.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Molinette Hospital University of Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. Consorziale Policlinico
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. Ospedali Riuniti Foggia
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto Oncologico Veneto IRCCS (IOV)
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria
City
Verona
State/Province
Veneto
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Withdrawn
Facility Name
A.O.U.I. Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Ist Nazionale Tumori GE - Oncologia Medica
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O. di Perugia - Ospedale Santa Maria della Misericordia - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA
City
Perugia
ZIP/Postal Code
06123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Santa Chiara Hospital
City
Trento
ZIP/Postal Code
38122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Auckland City Hosptial
City
Auckland
Country
New Zealand
Individual Site Status
Not yet recruiting
Facility Name
Canterbury Urology Research Trust
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Individual Site Status
Not yet recruiting
Facility Name
Tauranga Urology Research Limited
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Individual Site Status
Not yet recruiting
Facility Name
Centro Clinico Academico - Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
IPO Lisboa
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Hospital CUF Tejo
City
Lisboa
ZIP/Postal Code
1350-352
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Fundacao Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Hospital da Luz - Lisboa
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar Universitário de Lisboa Norte | Heart and Vessels Department
City
Lisboa
ZIP/Postal Code
1649-028
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Fundació Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
MD Anderson International Espanya, S.A.
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
H. General Uiversitario Morales Meseguer - Department of Urology
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Virgen de la Victoria | Cardiology Department
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Virgen del Rocio University Hospital - Oncology Department
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Goteborgs Universitet
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Skane University Hospital - Department of Urology
City
Malmo
ZIP/Postal Code
20502
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru
City
Bedford
State/Province
Bedfordshire
ZIP/Postal Code
MK42 9DJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Mount Vernon Cancer Centre
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7WG
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PQ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Marsden Hospital (London)
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

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