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Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC (ANZadapt)

Primary Purpose

Prostatic Neoplasms, Castration-Resistant

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Patient-specific adaptive therapy
Abiraterone acetate
Enzalutamide
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms, Castration-Resistant focused on measuring Antineoplastic Agents, Hormonal, Evolution, Quality of Life, Prostatic Neoplasms, Castration-Resistant / drug therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Willing and able to provide informed consent;
  2. Aged 18 or older;
  3. Histologically or cytologically confirmed adenocarcinoma of the prostate;
  4. Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e. surgical or medical castration with testosterone at screening ≤1.7 nmol/L (<0.5 ng/L)); patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
  5. Presence of metastatic disease on WBBS and/or CT-scan;
  6. Progressive disease at study entry defined as per PCWG3 as one or more of the following criteria that occurred while the patient was on ADT:

    1. PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥4 weeks since last flutamide or ≥6 weeks since last bicalutamide or nilutamide); OR
    2. Radiographic PD on bone scintigraphy and/or CT-scan;
  7. A PSA concentration of ≥10 ng/mL.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  9. Controlled symptoms (opioids for cancer related pain stable for >4 weeks, no need for urgent radiotherapy for symptomatic lesions);
  10. Estimated life expectancy of ≥12 months;
  11. Patient has archival prostate cancer tissue available and which he consents to share or is willing to undergo a new tumour biopsy;
  12. Adequate organ function: absolute neutrophil count > 1,500/μL (> 1.5*109/L); platelet count > 100,000/μL (> 100*109/L), haemoglobin > 90 g/L; total bilirubin < 1.5 times ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 times ULN; creatinine < 175 μmol/L; albumin > 30 g/L;
  13. Any other therapies for CRPC (excluding denosumab and bisphosphonates) have to be discontinued 3 weeks prior to study randomisation;
  14. Able to swallow the study drug and comply with study requirements.

Exclusion Criteria:

  1. Life-threatening or serious medical or psychiatric illness that could, in investigator's opinion, potentially interfere with participation in this study;
  2. Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs. Potential participants with non-melanoma skin cancer, non-muscle invasive bladder cancer, or carcinoma in situ of any type are allowed if they have undergone complete resection;
  3. Known or suspected brain metastasis or leptomeningeal disease;
  4. Small-cell or neuroendocrine differentiation of prostate cancer;
  5. Radiation therapy for treatment of the primary tumour within 3 weeks of screening visit;
  6. Radiation or radionuclide therapy for treatment of metastasis within 3 weeks of screening visit, excluding radiation to reduce pain symptoms;
  7. History of uncontrolled seizures (if patient and investigator wish to choose treatment with enzalutamide)
  8. Unstable symptomatic ischemic heart disease, ongoing arrhythmias or New York Heart Association (NYHA) Class III or IV heart failure;
  9. Known HIV infection, active chronic hepatitis B or C;
  10. Known gastrointestinal (GI) disease that could interfere with GI absorption/tolerance of study drugs;
  11. Prior treatments with CYP17 inhibitors (e.g. ketoconazole) or novel androgen receptor inhibitors (e.g. abiraterone, apalutamide, darolutamide or enzalutamide). Bicalutamide and nilutamide should be stopped >6 weeks before screening visit. Prior treatment with docetaxel in the mHSPC setting is allowed.
  12. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.

Sites / Locations

  • Border Medical Oncology Research Unit / The Border Cancer HospitalRecruiting
  • Chris O'Brien Lifehouse
  • Calvary Mater NewcastleRecruiting
  • Genesis Care North ShoreRecruiting
  • Sydney Adventist Hospital
  • Mater Hospital BrisbaneRecruiting
  • Royal Adelaide HospitalRecruiting
  • Fiona Stanly HospitalRecruiting
  • Radboud Univeristy Medical CentreRecruiting
  • Spaarne Gasthuis
  • Isala Ziekenhuis
  • Meander Medical CentreRecruiting
  • Groene Hart Ziekenhuis
  • Leids Universitair Medisch CentrumRecruiting
  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

In the experimental group, treatment will be paused if there is a >50% decline in baseline PSA. AA/ENZ will be restarted if the PSA rises to the same level or higher than the pre-treatment PSA. AA/ENZ treatment will be paused again after the PSA declines >50% from the baseline. This pause/restart cycle of adaptive therapy will be repeated presuming consent, tolerance and safety. Patients who do not have a >50% decline of their baseline PSA level after restarting AA/ENZ remain on treatment until the criteria for treatment failure are met.

In the control group, patients will receive the standard continuous treatment with abiraterone or enzalutamide (AA/ENZ) until criteria for treatment failure are met.

Outcomes

Primary Outcome Measures

Time to treatment failure
Defined as the time from randomization until death by any cause, or the occurrence of ≥2 of the following events: Radiographic progression according to RECIST 1.1 and/or PWCG3 criteria on the CT-scan and/or WBBS while a subject received treatment with AA/ENZ during the whole period between the imaging tests. NB: Radiologic progression while a subject is off treatment in the experimental arm will trigger the endpoint, but may be an indication to restart treatment and continue with the adaptive dosing strategy PSA progression, defined as an increase of PSA of >25% and >2 ng/mL occurring while a patient is on consecutive treatment with AA/ENZ for at least 8 weeks. Clinical progression in the judgment of the treating clinician occurring while a patient is on consecutive treatment with AA/ENZ for at least 8 weeks.

Secondary Outcome Measures

Time to PSA progression while on treatment
defined as the time from randomization until an increase of PSA of >25% and >2 ng/mL persisting while a patient is on consecutive treatment for at least 8 weeks (according to PCWG3 criteria) or death. Patients without documented PSA progression or have not died will be censored at the last known time that the patient was progression-free. Patients who are lost to follow up will be censored at their last assessment time. Patients who begin a new anticancer treatment and have not had documented PSA progression will be censored at their last assessment point prior to beginning their new treatment.
Radiographic progression-free survival while on study treatment
Defined as the time from randomisation to first occurrence of radiographic progression by PCWG3 criteria and/or RECIST 1.1 on the CT-scan and/or WBBS while a subject received treatment with AA/ENZ during the whole period between the imaging tests or death. Patients without documented disease progression or have not died will be censored at the last known time that the patient was progression-free. Patients who are lost to follow up will be censored at their last assessment time. Patients who begin a new anticancer treatment and have not had a documented treatment failure event will be censored at their last assessment point prior to beginning their new treatment.
Overall survival
defined as the time from randomization to the date of death due to any cause. For patients with no documented death by the end of the study, OS will be censored on the last date the patient was known to be alive. Patients who are lost to follow up will be censored at their last assessment time. Patients who begin a new anticancer treatment and have not had a documented treatment failure event will be censored at their last assessment point prior to beginning their new treatment.
Time to first skeletal-related event
Time from randomization to first skeletal-related event or death will be assessed. A skeletal-related event is defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of anti-neoplastic therapy to treat bone pain. Patients without documented skeletal-related event or have not died will be censored at the last known time that the patient was progression-free. Patients who are lost to follow up will be censored at their last assessment time. Patients who begin a new anticancer treatment and have not had a documented treatment failure event will be censored at their last assessment point prior to beginning their new treatment.
Health Related Quality of Life - FACT-P
FACT-P Quality of Life questionnaire
Health Related Quality of Life - EQ-5D-5L
EQ-5D-5L questionnaire.
Health Related Quality of Life - Pain
Pain score per Brief Pain Inventory.
Adverse events
An adverse event is defined as any symptom, sign, illness, or untoward experience (including a clinically significant laboratory finding classified as Grade 3 or higher by the National Cancer Institute's Common Terminology Criteria for Adverse Events v5.0) that develops or worsens during the course of the study, whether or not the event is considered related to study drug. Such an event should be recorded as an adverse event only after the first dose of study drug is taken. Adverse events will be assessed every 12 weeks.

Full Information

First Posted
May 18, 2022
Last Updated
May 5, 2023
Sponsor
Leiden University Medical Center
Collaborators
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Anticancer Fund, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT05393791
Brief Title
Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC
Acronym
ANZadapt
Official Title
ANZadapt: Phase II Randomised Controlled Trial of Patient-specific Adaptive Versus Continuous Abiraterone or eNZalutamide in Metastatic Castration-resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
November 10, 2027 (Anticipated)
Study Completion Date
November 10, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Anticancer Fund, Belgium

4. Oversight

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

5. Study Description

Brief Summary
Hormone tablets, abiraterone (Zytiga®) and enzalutamide (Xtandi®) are approved to treat advanced prostate cancer. However, even if these drugs are helpful, their effectiveness usually diminishes over time. Small pilot studies have indicated that using hormone tablets sparingly, for just long enough to control the cancer, followed by a break in treatment and restarting them later, seems to improve how long hormone tablets can control the cancer. This study aims to find out if this pause/restart strategy is better than taking hormone tablets every day continuously. The study will include 168 people with metastatic castrate resistant prostate cancer in the Netherlands and Australia. Patients will be randomly 1:1 assigned between the control group and the experimental group. In the control group, patients will take the treatment with AA/ENZ every day until the prostate cancer doesn't respond anymore to the treatment. In the experimental group, patients will start with daily AA/ENZ until the PSA has declined for >50%. The treatment will then be paused and monthly PSA measurements will be performed. The treatment will be re-initiated when the PSA has increased to the level of before starting treatment. The treatment will be continued daily until the PSA has again dropped for >50%. This pause/restart cycle will be repeated until the prostate cancer doesn't respond anymore to the treatment.
Detailed Description
Abiraterone and enzalutamide (AA/ENZ) are drugs which are being used to treat metastatic prostate cancer. These drugs are a form of additional hormonal therapy and have been used for many years. For most patients, these drugs work well and the prostate cancer stays under control for several months to years. In all patients, there will be a moment when the prostate cancer doesn't respond anymore to the treatment. This is called resistance. This leads to increasement of PSA, tumor growth on the CT-scan and/or bone scan or decline of condition. The investigators want to establish if it is possible to delay the development of resistance by using the drugs differently. It is now recommended to use AA/ENZ daily until the prostate cancer doesn't respond anymore to the treatment. During treatment, all cancer cells sensitive to treatment will die and all cells resistant for treatment will survive. Based on evolutionary principles, this might not be a wise strategy. The groups of resistant cancer cells will prevail and will grow faster and faster. This will lead to increasement of PSA, tumor growth on the CT-scan and/or bone scan or decline of condition. The investigators want to establish if it is better to not take the treatment drugs daily, but to pause the treatment on regular basis. The theory of the investigators is that, due to just in time pausing the treatment, a part of the treatment sensitive cells will remain alive. These treatment sensitive cancer cells will compete with the treatment resistant cells for limited space and nutrients. In this way, the treatment sensitive cancer cells prevent the accelerating growth of the treatment resistant cancer cells. Due to this phenomenon, the investigator hypothesis is the prostate cancer will respond longer to treatment. It will take longer until a new treatment is necessary or until a patients develops complaints. When the treatment is paused, patients might experience less side effects. It is easy to establish whether the prostate cancer responds to treatment by measuring PSA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Castration-Resistant
Keywords
Antineoplastic Agents, Hormonal, Evolution, Quality of Life, Prostatic Neoplasms, Castration-Resistant / drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Control group and experimental group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
In the experimental group, treatment will be paused if there is a >50% decline in baseline PSA. AA/ENZ will be restarted if the PSA rises to the same level or higher than the pre-treatment PSA. AA/ENZ treatment will be paused again after the PSA declines >50% from the baseline. This pause/restart cycle of adaptive therapy will be repeated presuming consent, tolerance and safety. Patients who do not have a >50% decline of their baseline PSA level after restarting AA/ENZ remain on treatment until the criteria for treatment failure are met.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
In the control group, patients will receive the standard continuous treatment with abiraterone or enzalutamide (AA/ENZ) until criteria for treatment failure are met.
Intervention Type
Other
Intervention Name(s)
Patient-specific adaptive therapy
Intervention Description
Patients will start taking abiraterone or enzalutamide (AA/ENZ) daily. PSA will be measured every month as well as radiological evaluation by CT-scan and bone scan. Treatment will be continued until PSA has dropped >50%. The treatment will then be paused. Once the PSA has risen again above the pretreatment baseline, treatment will be re-initiated. AA/ENZ will be stopped again after the PSA declines >50% from the baseline. This will be continued until criteria for treatment failure are met (death by any cause or at least 2 out of 3 of the following events while on treatment: radiographic progression on CT-scan and/or bone scan, PSA progression or clinical progression).
Intervention Type
Drug
Intervention Name(s)
Abiraterone acetate
Other Intervention Name(s)
Zytiga
Intervention Description
Use of abiraterone or enzalutamide
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi
Intervention Description
Use of abiraterone or enzalutamide
Primary Outcome Measure Information:
Title
Time to treatment failure
Description
Defined as the time from randomization until death by any cause, or the occurrence of ≥2 of the following events: Radiographic progression according to RECIST 1.1 and/or PWCG3 criteria on the CT-scan and/or WBBS while a subject received treatment with AA/ENZ during the whole period between the imaging tests. NB: Radiologic progression while a subject is off treatment in the experimental arm will trigger the endpoint, but may be an indication to restart treatment and continue with the adaptive dosing strategy PSA progression, defined as an increase of PSA of >25% and >2 ng/mL occurring while a patient is on consecutive treatment with AA/ENZ for at least 8 weeks. Clinical progression in the judgment of the treating clinician occurring while a patient is on consecutive treatment with AA/ENZ for at least 8 weeks.
Time Frame
Time from randomization until death by any cause, or until criteria for treatment failure are met. PSA progression and clinical progression will be measured every 4 weeks, radiographic progression every 12 weeks, both up to 3 years after randomization.
Secondary Outcome Measure Information:
Title
Time to PSA progression while on treatment
Description
defined as the time from randomization until an increase of PSA of >25% and >2 ng/mL persisting while a patient is on consecutive treatment for at least 8 weeks (according to PCWG3 criteria) or death. Patients without documented PSA progression or have not died will be censored at the last known time that the patient was progression-free. Patients who are lost to follow up will be censored at their last assessment time. Patients who begin a new anticancer treatment and have not had documented PSA progression will be censored at their last assessment point prior to beginning their new treatment.
Time Frame
Time from randomization until an increase of PSA of >25% and >2 ng/mL persisting while a patient is on consecutive treatment for at least 8 weeks or death. PSA will be measured every 4 weeks until 3 years after randomization.
Title
Radiographic progression-free survival while on study treatment
Description
Defined as the time from randomisation to first occurrence of radiographic progression by PCWG3 criteria and/or RECIST 1.1 on the CT-scan and/or WBBS while a subject received treatment with AA/ENZ during the whole period between the imaging tests or death. Patients without documented disease progression or have not died will be censored at the last known time that the patient was progression-free. Patients who are lost to follow up will be censored at their last assessment time. Patients who begin a new anticancer treatment and have not had a documented treatment failure event will be censored at their last assessment point prior to beginning their new treatment.
Time Frame
Time from randomization to death or the first occurrence of radiographic progression while a subject received treatment between the imaging tests. Bone scan and CT-scan will be measured every 12 weeks until 3 years after randomization.
Title
Overall survival
Description
defined as the time from randomization to the date of death due to any cause. For patients with no documented death by the end of the study, OS will be censored on the last date the patient was known to be alive. Patients who are lost to follow up will be censored at their last assessment time. Patients who begin a new anticancer treatment and have not had a documented treatment failure event will be censored at their last assessment point prior to beginning their new treatment.
Time Frame
Time from randomization to the date of death due to any cause. Measured every 4 weeks up to 3 years after randomizaton and after end of treatment visit every 6 months until 2 years after end of treatment visit.
Title
Time to first skeletal-related event
Description
Time from randomization to first skeletal-related event or death will be assessed. A skeletal-related event is defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of anti-neoplastic therapy to treat bone pain. Patients without documented skeletal-related event or have not died will be censored at the last known time that the patient was progression-free. Patients who are lost to follow up will be censored at their last assessment time. Patients who begin a new anticancer treatment and have not had a documented treatment failure event will be censored at their last assessment point prior to beginning their new treatment.
Time Frame
Time from randomization to first skeletal-related event or death. Bone scan and CT-scan will be measured every 12 weeks up to 3 years after randomization.
Title
Health Related Quality of Life - FACT-P
Description
FACT-P Quality of Life questionnaire
Time Frame
FACT-P questionnaire will be obtained every 12 weeks up to 3 years after randomization
Title
Health Related Quality of Life - EQ-5D-5L
Description
EQ-5D-5L questionnaire.
Time Frame
EQ-5D-5L questionnaire will be obtained every 12 weeks up to 3 years after randomization
Title
Health Related Quality of Life - Pain
Description
Pain score per Brief Pain Inventory.
Time Frame
Brief Pain Inventory questionnaire will be obtained every 12 weeks up to 3 years after randomization
Title
Adverse events
Description
An adverse event is defined as any symptom, sign, illness, or untoward experience (including a clinically significant laboratory finding classified as Grade 3 or higher by the National Cancer Institute's Common Terminology Criteria for Adverse Events v5.0) that develops or worsens during the course of the study, whether or not the event is considered related to study drug. Such an event should be recorded as an adverse event only after the first dose of study drug is taken. Adverse events will be assessed every 12 weeks.
Time Frame
Adverse events will be measured every 12 weeks, up to 3 years after randomization.
Other Pre-specified Outcome Measures:
Title
Cost-effectiveness analysis
Description
A cost-utility analysis will be performed from a healthcare perspective. Medication and other hospital costs will be assessed from hospital registrations. Quality-adjusted life years (QALYs) will be estimated using the Dutch tariff for the EQ-5D-5L (and the EQ-VAS as secondary analysis). Costs and QALYs will be extrapolated to a life-long horizon.
Time Frame
QoL and adverse events will be measured every 12 weeks up to 3 years after randomization. Treatment duration will be evaluated every 4 weeks up to 3 years after randomization.
Title
Cumulative duration on treatment
Description
defined as the number of weeks on active treatment from randomization to the occurrence of treatment failure while on treatment.
Time Frame
Every 4 weeks up to 3 years after randomization
Title
Translational Biospecimens
Description
Plasma samples suitable for circulating tumour DNA (ctDNA) analyses will be collected. The aim would be to perform explorative analyses on ctDNA to understand mechanisms of resistance, predictors of occurrence of progressive disease, and whether these results support the eco-evolutionary dynamics theory.
Time Frame
Baseline and every 12 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
As the investigated disease is prostate cancer, only males are eligible for inclusion.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to provide informed consent; Aged 18 or older; Histologically or cytologically confirmed adenocarcinoma of the prostate; Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e. surgical or medical castration with testosterone at screening ≤1.7 nmol/L (<0.5 ng/L)); patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial; Presence of metastatic disease on WBBS and/or CT-scan; Progressive disease at study entry defined as per PCWG3 as one or more of the following criteria that occurred while the patient was on ADT: PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥4 weeks since last flutamide or ≥6 weeks since last bicalutamide or nilutamide); OR Radiographic PD on bone scintigraphy and/or CT-scan; A PSA concentration of ≥10 ng/mL. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Controlled symptoms (opioids for cancer related pain stable for >4 weeks, no need for urgent radiotherapy for symptomatic lesions); Estimated life expectancy of ≥12 months; Patient has archival prostate cancer tissue available and which he consents to share or is willing to undergo a new tumour biopsy; Adequate organ function: absolute neutrophil count > 1,500/μL (> 1.5*109/L); platelet count > 100,000/μL (> 100*109/L), haemoglobin > 90 g/L; total bilirubin < 1.5 times ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 times ULN; creatinine < 175 μmol/L; albumin > 30 g/L; Any other therapies for CRPC (excluding denosumab and bisphosphonates) have to be discontinued 3 weeks prior to study randomisation; Able to swallow the study drug and comply with study requirements. Exclusion Criteria: Life-threatening or serious medical or psychiatric illness that could, in investigator's opinion, potentially interfere with participation in this study; Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs. Potential participants with non-melanoma skin cancer, non-muscle invasive bladder cancer, or carcinoma in situ of any type are allowed if they have undergone complete resection; Known or suspected brain metastasis or leptomeningeal disease; Small-cell or neuroendocrine differentiation of prostate cancer; Radiation therapy for treatment of the primary tumour within 3 weeks of screening visit; Radiation or radionuclide therapy for treatment of metastasis within 3 weeks of screening visit, excluding radiation to reduce pain symptoms; History of uncontrolled seizures (if patient and investigator wish to choose treatment with enzalutamide) Unstable symptomatic ischemic heart disease, ongoing arrhythmias or New York Heart Association (NYHA) Class III or IV heart failure; Known HIV infection, active chronic hepatitis B or C; Known gastrointestinal (GI) disease that could interfere with GI absorption/tolerance of study drugs; Prior treatments with CYP17 inhibitors (e.g. ketoconazole) or novel androgen receptor inhibitors (e.g. abiraterone, apalutamide, darolutamide or enzalutamide). Bicalutamide and nilutamide should be stopped >6 weeks before screening visit. Prior treatment with docetaxel in the mHSPC setting is allowed. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom van der Hulle, MD PhD
Phone
0031715263464
Email
t.van_der_hulle@lumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret McJannett
Phone
+61 2 9046 8954
Email
trials@anzup.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom van der Hulle, MD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A/Prof. Craig Gedye, MBChB,FRACP
Organizational Affiliation
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Laurence Krieger, MBChB,FRACP
Organizational Affiliation
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Amy Rieborn
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Border Medical Oncology Research Unit / The Border Cancer Hospital
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2460
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Underhill
Email
cunderhill@bordermedonc.com.au
First Name & Middle Initial & Last Name & Degree
Jacqui McBurnie
Phone
+61260641508
Email
jacqui.mcburnie@bordermedonc.com.au
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacquie Harvey, MBBS FRACP
Phone
+61 2 8514 0194
Email
Jacquie.Harvey@lh.org.au
First Name & Middle Initial & Last Name & Degree
Prof. Lisa Horvath, Horvath
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Adler
Phone
+612 40143282
Email
kim.adler@calvarymater.org.au
First Name & Middle Initial & Last Name & Degree
A.Prof. Craig Gedye, MBChB FRACP
Facility Name
Genesis Care North Shore
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Till
Phone
+61 474 164 541
Email
Grace.Till@genesiscare.com
First Name & Middle Initial & Last Name & Degree
Dr. Laurence Krieger, MBChB, FRACP
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 Contact:
First Name & Middle Initial & Last Name & Degree
Nina Singh
Phone
+61 2 9480 6280
Email
nina.singh@sah.org.au
First Name & Middle Initial & Last Name & Degree
Prof. Gavin Marx
Facility Name
Mater Hospital Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Harvey
Email
Donna.Harvey@mater.org.au
First Name & Middle Initial & Last Name & Degree
Dr. Niara Oliveira
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiang Tan
Phone
+6170742336
Email
hsiang.tan@sa.gov.au
Facility Name
Fiona Stanly Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Stone
Phone
+61 8 6152 6530
Email
caroline.stone@health.wa.gov.au
First Name & Middle Initial & Last Name & Degree
Dr Thomas Ferguson
Facility Name
Radboud Univeristy Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge van Oort, MD PhD
Phone
0031243613735
Email
inge.vanoort@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Inge van Oort, MD PhD
Facility Name
Spaarne Gasthuis
City
Hoofddorp
State/Province
Noord-Holland
ZIP/Postal Code
2134 TM
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aart Beeker, MD PhD
Phone
0031232245802
Email
abeeker@spaarnegasthuis.nl
First Name & Middle Initial & Last Name & Degree
Aart Beeker, MD PhD
Facility Name
Isala Ziekenhuis
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Metin Tascilar, MD PhD
Email
m.tascilar@isala.nl
First Name & Middle Initial & Last Name & Degree
Metin Tascilar, MD PhD
Facility Name
Meander Medical Centre
City
Amersfoort
State/Province
Utrecht
ZIP/Postal Code
3813 TZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce van Dodewaard - de Jong, MD PhD
Phone
0031338507278
Email
jm.van.dodewaard@meandermc.nl
First Name & Middle Initial & Last Name & Degree
Joyce van Dodewaard - de Jong, MD PhD
Facility Name
Groene Hart Ziekenhuis
City
Gouda
State/Province
Zuid-Holland
ZIP/Postal Code
2803 HH
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy van der Deure, MD PhD
Phone
0031182505005
Email
Wendy.van.der.Deure@ghz.nl
First Name & Middle Initial & Last Name & Degree
Wendy van der Deure, MD PhD
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom van der Hulle, MD PhD
Phone
0031715263464
Email
t.van_der_hulle@lumc.nl
First Name & Middle Initial & Last Name & Degree
Amy Rieborn, MD
Phone
0031652887817
Email
a.rieborn@lumc.nl
First Name & Middle Initial & Last Name & Degree
Tom van der Hulle, MD PhD
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel van Kruchten, MD PhD
Email
m.van.kruchten@umcg.nl
First Name & Middle Initial & Last Name & Degree
Michel van Kruchten, MD PhD

12. IPD Sharing Statement

Learn more about this trial

Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC

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