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A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone (PRESIDE)

Primary Purpose

Metastatic Castration Resistant Prostate Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Enzalutamide

Docetaxel

Prednisolone

Placebo

About this trial

This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer focused on measuring Metastatic, Castration-resistant, Docetaxel, Chemotherapy- Naïve, Enzalutamide, Prostate Cancer, Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer, Prednisolone, Xtandi, Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
Ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of initiation of investigational medicinal product (IMP), or bilateral orchiectomy (i.e., surgical or medical castration);
Metastatic disease documented by at least 2 bone lesions on bone scan, or soft tissue disease documented by computed tomography (CT)/magnetic resonance imaging (MRI);
Progressive disease at study entry defined as the following occurring in the setting of castrate levels of testosterone: Prostate specific antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination.
Asymptomatic or minimally symptomatic prostate cancer (Brief Pain Inventory - Short Form (BPI-SF) question 3 score of < 4);
Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;
Estimated life expectancy of ≥ 12 months;
Be suitable and willing to receive chemotherapy as part of the trial;
Able to swallow the IMP and comply with study requirements;
Subject agreed not to participate in another interventional study while on treatment.

Exclusion Criteria:

Prior treatment with the following agents for the treatment of prostate cancer: Aminoglutethimide; Ketoconazole; Abiraterone; Enzalutamide or participation in a clinical trial of enzalutamide; 223Ra, 89Sr, 153Sm, 186Re/188Re; Immunomodulatory therapies; Cytotoxic chemotherapy; Participation in a clinical trial of an investigational agent that inhibits the AR or androgen synthesis unless the treatment was placebo;
Current or prior treatment within 4 weeks prior to initiation of investigational medicinal product (IMP) with the following agents for the treatment of prostate cancer: Antiandrogens; 5-α reductase inhibitors; Estrogens; Anabolic steroids; Drugs with antiandrogenic properties; Progestational agents;
Subject had received investigational therapy within 28 days or 5 half-lives whichever was longer, prior to initiation of IMP;
Use of opiate analgesia for pain from prostate cancer within 4 weeks prior to initiation of IMP;
Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to initiation of IMP;
Major surgery within 4 weeks prior to initiation of IMP;
History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months prior to Screening;
Known or suspected brain metastasis or active leptomeningeal disease;
History of another malignancy within the previous 5 years other than non-melanoma skin cancer;
Clinically significant cardiovascular disease;
Gastrointestinal disorders affecting absorption;
Medical contraindications to the use of prednisolone or docetaxel;
Allergies to any of the active ingredients or excipients in the study drugs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enzalutamide

Placebo

Arm Description

Participants received an OL treatment with enzalutamide 160 milligrams (mg) capsules, orally once daily from day 1 in period 1 until randomization to period 2, confirmation of ineligibility for period 2, intolerable toxicity, withdrawal, or death. Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received enzalutamide 160 mg capsules, orally once daily in combination with docetaxel 75 milligrams per square meter (mg/m^2) in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, DB period 2. Docetaxel and prednisolone were administered up to 10 cycles (3 weeks/cycle) or more as assessed by the investigator. Enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death. Participants could continue the extension period, until investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death.

Participants received an OL treatment with enzalutamide 160 mg capsules, orally once daily from day 1 in period 1 until randomization to period 2, confirmation of ineligibility for period 2, intolerable toxicity, withdrawal, or death. Participants with confirmed disease progression on enzalutamide in period 1 and who continued to meet all eligibility criteria received placebo matched to enzalutamide, orally once daily in combination with docetaxel 75 mg/m^2 in a one-hour infusion every 3 weeks and prednisolone 5 mg orally twice daily, in period 2. Docetaxel and prednisolone were administered up to 10 cycles (3 weeks/cyle) or more as assessed by the investigator. Enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death. Participants could continue the extension period, until investigator or participant decided to stop or disease progression, intolerable toxicity, withdrawal or death.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

PFS: time from randomization (Period 2 Week 1) to earliest progression event. Progression is defined as radiographic progression, unequivocal clinical progression, or death on study. Radiographic progression is defined for bone disease by appearance of ≥ 2 new lesions on whole-body radionuclide bone scan per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria (i.e., unconfirmed progressive disease) that needs to be confirmed in the next assessment (i.e., progressive disease in the next assessment) or for soft tissue disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Unequivocal clinical progression is defined as new onset cancer pain requiring chronic administration of opiate analgesia or deterioration from prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to ≥ 3, or initiation of subsequent lines of cytotoxic chemotherapy or radiation therapy or surgical intervention due to complications of tumor progression.

Secondary Outcome Measures

Time to Prostate-specific Antigen (PSA) Progression

Time to PSA progression, defined as the time from randomization (Period 2 Week 1) to the date of the first PSA value in Period 2 demonstrating progression (Period 2). The PSA progression date is defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir recorded in Period 2 is documented, which must be confirmed by a second consecutive value obtained at least 3 weeks later.

Prostate-specific Antigen (PSA) Response

PSA response, defined as a decrease in percentage change from randomization (Period 2 Week 1) of 50% or more. PSA response was derived at Week 13 and at any time after randomization in Period 2. PSA response at any time is defined as a decrease in percentage change from randomization (Period 2 Week 1) at any time after randomization of 50% or more. Percentage of participants with PSA response was reported.

Objective Response Rate (ORR)

ORR, defined as the best overall radiographic response after randomization (Period 2 Week 1) as per Investigator assessments of response for soft tissue disease per RECIST 1.1, in participants who had a measurable tumor. ORR was reported as the percentage of participants with complete response (CR) or partial response (PR). CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.

Time to Pain Progression

The time to an increase of >=30% from randomization (Period 2 Week 1) in average BPI-SF item scores (items 3, 4, 5, 6) at two consecutive evaluations >=3 weeks apart without decrease in analgesic score according to the World health Organization (WHO). Only participants with an average pain intensity item score >=4 were considered. The BPI-SF was an instrument to document pain-related functional impairment and contains 7 questions which included pain intensity [(items 3, 4, 5 and 6): worst pain, least pain, average pain and current pain, with scales from 0 (no pain) to 10 (pain as bad as you can imagine)] and pain interference ](items 9A to 9G): general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life, with scales from 0 (does not interfere) to 10 (completely interferes)]. The BPI-SF total score for pain intensity was calculated as the mean of the 4 scores for the 4 items of pain intensity.

Time to Opiate Use for Cancer-related Pain

Time to opiate use for cancer-related pain, defined as the time from randomization (Period 2 Week 1) to initiation of chronic administration of opiate analgesia [parenteral opiate use for ≥7 days or use of WHO Analgesic Ladder Level 3 oral opiates for ≥3 weeks].

Time to First Skeletal-related Event (SRE)

Time to first SRE, defined as the time from randomization (Period 2 Week 1) to radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain.

Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)

FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer participants. It consists of 27 core items which assess participant function in four domains rated on 0 to 4 Likert-type scale: physical well-being (PWB) (7 items; 0 [worst] to 4 [better], score range 0-28), social/family well-being (SWB) (7 items; 0 [worst] to 4 [better], score range 0-28), emotional well-being (EWB) (6 items; 0 [worst] to 4 [better], score range 0-24), and functional well-being (FWB) (7 items; 0 [worst] to 4 [better], score range 0-28), which is further supplemented by 12 site-specific items to assess for prostate-related symptoms (Prostate Cancer Subscale [PCS] 12 items rated on Likert-type scale 0 [worst] to 4 [better], score range 0-48). The total domain scores and PCS subscale score are then combined to a global quality of life score ranging between 0 to 156; higher scores representing better quality of life.

Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)

The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable).

Full Information

NCT ID

NCT02288247

First Posted

November 7, 2014

Last Updated

October 2, 2023

Sponsor

Astellas Pharma Europe Ltd.

Collaborators

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02288247

Brief Title

A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

Acronym

PRESIDE

Official Title

A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 1, 2014 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Europe Ltd.

Collaborators

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study was to understand if there was benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer had gotten worse when treated with enzalutamide alone.

Detailed Description

The study was conducted in consecutive periods of open label treatment with enzalutamide followed by randomized double-blind treatment with continued enzalutamide or placebo, in combination with docetaxel and prednisolone. Open Label (Period 1) Participants received open label treatment (OL) with enzalutamide. At week 13, all participants were assessed by prostate-specific antigen (PSA) and imaging. Participants with no confirmed PSA response or evidence of radiographic progression were ineligible for participation in Period 2 and typically had safety follow up; however, Period 1 treatment continued for some participants as long as the investigator considered it to be of clinical benefit (stopping on initiation of any new antineoplastic therapy). Participants with confirmed PSA response continued Period 1 until disease progression. Enrollment to Period 2 ceased after approximately 274 participants had been enrolled or 182 primary endpoint events had been reached, whichever occurred first. Participants who were not randomized into period 2 at this time continued to receive open label treatment in an extension period. Randomization (Double Blind [DB]) (Period 2) Participants with confirmed disease progression on enzalutamide alone who continued to meet all eligibility criteria proceeded to randomization. Treatment allocation was in a 1:1 ratio, stratified by disease progression in Period 1 to the following treatments: Enzalutamide with docetaxel and prednisolone Placebo with docetaxel and prednisolone Any ongoing participants in Period 2 at the point of unblinding in the enzalutamide+docetaxel arm that were still receiving and benefitting from enzalutamide treatment, had the option to continue treatment via an extension period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration Resistant Prostate Cancer

Keywords

Metastatic, Castration-resistant, Docetaxel, Chemotherapy- Naïve, Enzalutamide, Prostate Cancer, Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer, Prednisolone, Xtandi, Metastatic Castration Resistant Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

688 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enzalutamide

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Enzalutamide

Other Intervention Name(s)

Xtandi, ASP9785

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

From date of randomization to the earliest of either documented disease progression (median duration: 35 weeks)

Secondary Outcome Measure Information:

Title

Time to Prostate-specific Antigen (PSA) Progression

Description

Time Frame

From date of randomization to the first PSA value (median duration: 35 weeks)

Title

Prostate-specific Antigen (PSA) Response

Description

Time Frame

Randomization, Week 13, any time after randomization in Period 2 (median of 35 weeks)

Title

Objective Response Rate (ORR)

Description

Time Frame

From date of randomization up to median duration of 35 weeks

Title

Time to Pain Progression

Description

Time Frame

From date of randomization up to median duration of 35 weeks

Title

Time to Opiate Use for Cancer-related Pain

Description

Time Frame

From date of randomization up to median duration of 35 weeks

Title

Time to First Skeletal-related Event (SRE)

Description

Time Frame

From date of randomization up to median duration of 35 weeks

Title

Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P)

Description

Time Frame

Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

Title

Change From Baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)

Description

The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled from 0 (worst health imaginable) to 100 (best health imaginable).

Time Frame

Period 2: Baseline, weeks 1, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157, 169, 181

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features; Ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of initiation of investigational medicinal product (IMP), or bilateral orchiectomy (i.e., surgical or medical castration); Metastatic disease documented by at least 2 bone lesions on bone scan, or soft tissue disease documented by computed tomography (CT)/magnetic resonance imaging (MRI); Progressive disease at study entry defined as the following occurring in the setting of castrate levels of testosterone: Prostate specific antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. Asymptomatic or minimally symptomatic prostate cancer (Brief Pain Inventory - Short Form (BPI-SF) question 3 score of < 4); Eastern Cooperative Oncology Group (ECOG) performance score of 0-1; Estimated life expectancy of ≥ 12 months; Be suitable and willing to receive chemotherapy as part of the trial; Able to swallow the IMP and comply with study requirements; Subject agreed not to participate in another interventional study while on treatment. Exclusion Criteria: Prior treatment with the following agents for the treatment of prostate cancer: Aminoglutethimide; Ketoconazole; Abiraterone; Enzalutamide or participation in a clinical trial of enzalutamide; 223Ra, 89Sr, 153Sm, 186Re/188Re; Immunomodulatory therapies; Cytotoxic chemotherapy; Participation in a clinical trial of an investigational agent that inhibits the AR or androgen synthesis unless the treatment was placebo; Current or prior treatment within 4 weeks prior to initiation of investigational medicinal product (IMP) with the following agents for the treatment of prostate cancer: Antiandrogens; 5-α reductase inhibitors; Estrogens; Anabolic steroids; Drugs with antiandrogenic properties; Progestational agents; Subject had received investigational therapy within 28 days or 5 half-lives whichever was longer, prior to initiation of IMP; Use of opiate analgesia for pain from prostate cancer within 4 weeks prior to initiation of IMP; Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to initiation of IMP; Major surgery within 4 weeks prior to initiation of IMP; History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months prior to Screening; Known or suspected brain metastasis or active leptomeningeal disease; History of another malignancy within the previous 5 years other than non-melanoma skin cancer; Clinically significant cardiovascular disease; Gastrointestinal disorders affecting absorption; Medical contraindications to the use of prednisolone or docetaxel; Allergies to any of the active ingredients or excipients in the study drugs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Astellas Pharma Europe Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Site AT43004

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Site AT43001

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Site BE32003

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

Site BE32002

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Site BE32004

City

Ottignies

ZIP/Postal Code

1340

Country

Belgium

Facility Name

Site CZ42004

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Site CZ42003

City

Olomouc

ZIP/Postal Code

77520

Country

Czechia

Facility Name

Site CZ42002

City

Plzeň -Lochotín

ZIP/Postal Code

30460

Country

Czechia

Facility Name

Site CZ42001

City

Praha 2

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Site FR33012

City

Albi

ZIP/Postal Code

81000

Country

France

Facility Name

Site FR33003

City

Montpellier

ZIP/Postal Code

34298 cedex 5

Country

France

Facility Name

Site FR33002

City

Nîmes

ZIP/Postal Code

30907 cedex 2

Country

France

Facility Name

Site FR33008

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Site FR33014

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Site FR33004

City

Plerin

ZIP/Postal Code

22190

Country

France

Facility Name

Site FR33013

City

Quimper

ZIP/Postal Code

29000

Country

France

Facility Name

Site FR33011

City

Reims

ZIP/Postal Code

51056

Country

France

Facility Name

Site FR33005

City

Suresnes

ZIP/Postal Code

92151

Country

France

Facility Name

Site DE49018

City

Nürtingen

State/Province

Baden-Württemberg

ZIP/Postal Code

72622

Country

Germany

Facility Name

Site DE49008

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Site DE49010

City

Bergisch Gladbach

ZIP/Postal Code

51465

Country

Germany

Facility Name

Site DE49001

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Site DE49006

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Site DE49003

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Site DE49002

City

Munster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Site DE49015

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Site DE49017

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

Site DE49004

City

Wuppertal

ZIP/Postal Code

42103

Country

Germany

Facility Name

Site GR30001

City

Heraklion

State/Province

Crete

ZIP/Postal Code

70013

Country

Greece

Facility Name

Site GR30004

City

Heraklion

State/Province

Crete

ZIP/Postal Code

71403

Country

Greece

Facility Name

Site GR30003

City

Athens

ZIP/Postal Code

14564

Country

Greece

Facility Name

Site GR30006

City

Athens

ZIP/Postal Code

155 62

Country

Greece

Facility Name

Site GR30005

City

Thessaloniki

ZIP/Postal Code

54007

Country

Greece

Facility Name

Site IT39001

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

Site IT39012

City

Brescia

ZIP/Postal Code

25126

Country

Italy

Facility Name

Site IT39003

City

Milano

ZIP/Postal Code

20100

Country

Italy

Facility Name

Site IT39008

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Site IT39010

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Site IT39005

City

Roma

ZIP/Postal Code

00128

Country

Italy

Facility Name

Site IT39004

City

Rome

ZIP/Postal Code

161

Country

Italy

Facility Name

Site IT39002

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Site NL31002

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Site NL31007

City

Blaricum

ZIP/Postal Code

1261 AN

Country

Netherlands

Facility Name

Site NL31004

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

Site NL31010

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Site NL31003

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

Facility Name

Site NO47005

City

Drammen

ZIP/Postal Code

3004

Country

Norway

Facility Name

Site NO47001

City

Kristiansand

ZIP/Postal Code

4615

Country

Norway

Facility Name

Site NO47004

City

Stavanger

ZIP/Postal Code

4011

Country

Norway

Facility Name

Site PL48004

City

Gdańsk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Site PL48003

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Site PL48002

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Site PL48006

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Site PL48005

City

Warszawa

ZIP/Postal Code

04-141

Country

Poland

Facility Name

Site RU70004

City

Obninsk

State/Province

Kaluga

ZIP/Postal Code

24903

Country

Russian Federation

Facility Name

Site RU70002

City

Moscow

ZIP/Postal Code

105077

Country

Russian Federation

Facility Name

Site RU70001

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Site RU70003

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Site RU70005

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Site RU70006

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Site ES34005

City

Lugo

ZIP/Postal Code

27003

Country

Spain

Facility Name

Site ES34003

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Site ES34001

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Site ES34002

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Site ES34010

City

Madrid

Country

Spain

Facility Name

Site ES34007

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Site ES34009

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

Site ES34008

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Site ES34004

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Site ES34006

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Site SE46002

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Site SE46005

City

Kalmar

ZIP/Postal Code

39185

Country

Sweden

Facility Name

Site SE46003

City

Solna

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Site SE46004

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Site CH41005

City

Locarno

State/Province

Tessin

ZIP/Postal Code

6600

Country

Switzerland

Facility Name

Site CH41009

City

Zurich

ZIP/Postal Code

CH-8038

Country

Switzerland

Facility Name

Site TR90001

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Site TR90003

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Site TR90002

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Site GB44010

City

Aberdeen

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

Site GB44004

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Site GB44018

City

Cardiff

ZIP/Postal Code

CF4 7XL

Country

United Kingdom

Facility Name

Site GB44014

City

Exeter

Country

United Kingdom

Facility Name

Site GB44003

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Site GB44020

City

Northwood

ZIP/Postal Code

HA62RN

Country

United Kingdom

Facility Name

Site GB44015

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Site GB44002

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Site GB44017

City

Swansea

ZIP/Postal Code

SA2 8QA

Country

United Kingdom

Facility Name

Site GB44007

City

Wirral

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

36265504

Citation

Merseburger AS, Attard G, Astrom L, Matveev VB, Bracarda S, Esen A, Feyerabend S, Senkus E, Lopez-Brea Piqueras M, Boysen G, Gourgioti G, Martins K, Chowdhury S. Continuous enzalutamide after progression of metastatic castration-resistant prostate cancer treated with docetaxel (PRESIDE): an international, randomised, phase 3b study. Lancet Oncol. 2022 Nov;23(11):1398-1408. doi: 10.1016/S1470-2045(22)00560-5. Epub 2022 Oct 18.

Results Reference

derived

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A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone (PRESIDE)

Metastatic Castration Resistant Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial