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
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
2 other identifiers
interventional
688
16 countries
89
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2014
Longer than P75 for phase_3
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedResults Posted
Study results publicly available
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedApril 8, 2025
April 1, 2025
5.4 years
November 7, 2014
September 29, 2021
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From date of randomization to the earliest of either documented disease progression (median duration: 35 weeks)
Secondary Outcomes (8)
Time to Prostate-specific Antigen (PSA) Progression
From date of randomization to the first PSA value (median duration: 35 weeks)
Prostate-specific Antigen (PSA) Response
Randomization, Week 13, any time after randomization in Period 2 (median of 35 weeks)
Objective Response Rate (ORR)
From date of randomization up to median duration of 35 weeks
Time to Pain Progression
From date of randomization up to median duration of 35 weeks
Time to Opiate Use for Cancer-related Pain
From date of randomization up to median duration of 35 weeks
- +3 more secondary outcomes
Study Arms (2)
Enzalutamide
EXPERIMENTALParticipants (Pts) received OL enzalutamide 160 mg QD from Day 1 in Period 1 (P1) until they were either randomized to Period 2 (P2), were ineligible, experienced intolerable toxicity, withdrew, or died. Pts with confirmed disease progression in P1, meeting eligibility, were randomized to receive placebo/enzalutamide 160 mg QD with docetaxel 75 mg/m\^2 in 1hour infusion every 3 weeks \& prednisolone 5mg twice daily in P2. Docetaxel \& prednisolone were administered for upto 10 cycles (1 cycle=3 weeks) or more per investigator discretion, while placebo/enzalutamide continued until progression, toxicity, withdrawal, or death. Extension(EXT) phase was available for Pts in P1\& P2 who were not meeting primary endpoint. Enzalutamide continued until disease progression, intolerable toxicity, withdrawal, or death. Pts not entering EXT discontinued and received local care. Those benefiting from enzalutamide in EXT at study closure continued in study 9785-CL-0123 or via commercial enzalutamide.
Placebo
PLACEBO COMPARATORParticipants received an OL treatment with enzalutamide 160 mg capsules, orally once daily from day 1 in period 1 until randomization to period 2 treatment, confirmation of ineligibility for period 2 treatment, intolerable toxicity, withdrawal, or death, whichever occurred first. 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, DB in period 2. Docetaxel and prednisolone were administered up to 10 cycles (1 cycle = 3 weeks) or additional cycles as assessed by the investigator and enzalutamide was administered until disease progression, intolerable toxicity, withdrawal or death, whichever occurred first. Participants discontinued the study and received local standard of care.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
Site AT43004
Linz, 4010, Austria
Site AT43001
Vienna, 1090, Austria
Site BE32003
Bonheiden, 2820, Belgium
Site BE32002
Liège, 4000, Belgium
Site BE32004
Ottignies, 1340, Belgium
Site CZ42004
Brno, 656 91, Czechia
Site CZ42003
Olomouc, 77520, Czechia
Site CZ42002
Plzeň -Lochotín, 30460, Czechia
Site CZ42001
Prague, 12808, Czechia
Site FR33012
Albi, 81000, France
Site FR33003
Montpellier, 34298 cedex 5, France
Site FR33002
Nîmes, 30907 cedex 2, France
Site FR33008
Paris, 75014, France
Site FR33014
Paris, 75014, France
Site FR33004
Plérin, 22190, France
Site FR33013
Quimper, 29000, France
Site FR33011
Reims, 51056, France
Site FR33005
Suresnes, 92151, France
Site DE49018
Nürtingen, Baden-Wurttemberg, 72622, Germany
Site DE49008
Aachen, 52074, Germany
Site DE49010
Bergisch Gladbach, 51465, Germany
Site DE49001
Hanover, 30625, Germany
Site DE49006
Heidelberg, 69120, Germany
Site DE49003
Mannheim, 68167, Germany
Site DE49002
Münster, 48149, Germany
Site DE49015
Tübingen, 72076, Germany
Site DE49017
Ulm, 89075, Germany
Site DE49004
Wuppertal, 42103, Germany
Site GR30001
Heraklion, Crete, 70013, Greece
Site GR30004
Heraklion, Crete, 71403, Greece
Site GR30003
Athens, 14564, Greece
Site GR30006
Athens, 155 62, Greece
Site GR30005
Thessaloniki, 54007, Greece
Site IT39001
Arezzo, 52100, Italy
Site IT39012
Brescia, 25126, Italy
Site IT39003
Milan, 20100, Italy
Site IT39008
Naples, 80131, Italy
Site IT39010
Pavia, 27100, Italy
Site IT39005
Roma, 00128, Italy
Site IT39004
Rome, 161, Italy
Site IT39002
Terni, 05100, Italy
Site NL31002
Amsterdam, 1066 CX, Netherlands
Site NL31007
Blaricum, 1261 AN, Netherlands
Site NL31004
Hoofddorp, 2134 TM, Netherlands
Site NL31010
Nieuwegein, 3435 CM, Netherlands
Site NL31003
Rotterdam, 3045 PM, Netherlands
Site NO47005
Drammen, 3004, Norway
Site NO47001
Kristiansand, 4615, Norway
Site NO47004
Stavanger, 4011, Norway
Site PL48004
Gdansk, 80-952, Poland
Site PL48003
Krakow, 31-501, Poland
Site PL48002
Lodz, 93-513, Poland
Site PL48006
Warsaw, 02-507, Poland
Site PL48005
Warsaw, 04-141, Poland
Site RU70004
Obninsk, Kaluga Oblast, 24903, Russia
Site RU70002
Moscow, 105077, Russia
Site RU70001
Moscow, 115478, Russia
Site RU70003
Moscow, 125284, Russia
Site RU70005
Saint Petersburg, 197022, Russia
Site RU70006
Saint Petersburg, 197758, Russia
Site ES34005
Lugo, 27003, Spain
Site ES34003
Madrid, 28007, Spain
Site ES34001
Madrid, 28040, Spain
Site ES34002
Madrid, 28041, Spain
Site ES34010
Madrid, Spain
Site ES34007
Málaga, 29010, Spain
Site ES34009
Murcia, 30008, Spain
Site ES34008
Santander, 39008, Spain
Site ES34004
Seville, 41013, Spain
Site ES34006
Valencia, 46009, Spain
Site SE46002
Gothenburg, 413 45, Sweden
Site SE46005
Kalmar, 39185, Sweden
Site SE46003
Solna, 171 76, Sweden
Site SE46004
Uppsala, 751 85, Sweden
Site CH41005
Locarno, Canton Ticino, 6600, Switzerland
Site CH41009
Zurich, CH-8038, Switzerland
Site TR90001
Ankara, 06500, Turkey (Türkiye)
Site TR90003
Istanbul, 34722, Turkey (Türkiye)
Site TR90002
Izmir, 35340, Turkey (Türkiye)
Site GB44010
Aberdeen, AB25 2ZN, United Kingdom
Site GB44004
Cambridge, CB2 0QQ, United Kingdom
Site GB44018
Cardiff, CF4 7XL, United Kingdom
Site GB44014
Exeter, United Kingdom
Site GB44003
London, SE1 9RT, United Kingdom
Site GB44007
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Site GB44020
Northwood, HA62RN, United Kingdom
Site GB44015
Norwich, NR4 7UY, United Kingdom
Site GB44002
Nottingham, NG5 1PB, United Kingdom
Site GB44017
Swansea, SA2 8QA, United Kingdom
Related Publications (1)
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.
PMID: 36265504DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure
- Organization
- Astellas Pharma Europe Ltd. (APEL)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Europe Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2014
First Posted
November 11, 2014
Study Start
December 1, 2014
Primary Completion
April 30, 2020
Study Completion
March 15, 2024
Last Updated
April 8, 2025
Results First Posted
December 15, 2021
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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 products 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. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.