Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
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|ClinicalTrials.gov Identifier: NCT02987543|
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Castration-resistant Prostate Cancer||Drug: olaparib Drug: enzalutamide Drug: abiraterone acetate||Phase 3|
This is a prospective, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have a qualifying tumor mutation in one of 15 genes involved in the homologous recombination repair (HRR) pathway. Subjects will be divided into two cohorts based on HRR gene mutation status.
Approximately 340 subjects will be randomized 2:1 (olaparib : investigator choice of enzalutamide or abiraterone acetate) into the trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)|
|Actual Study Start Date :||February 6, 2017|
|Estimated Primary Completion Date :||March 20, 2020|
|Estimated Study Completion Date :||February 5, 2021|
Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions
300 mg (2x 150 mg tablets) twice daily
Other Name: Lynparza
Active Comparator: Enzalutamide OR abiraterone acetate
Enzalutamide is available as capsules containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily.
Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg administered twice daily orally.
160 mg (4 x 40 mg capsules) once daily
Other Name: XTANDIDrug: abiraterone acetate
1,000 mg (4 x 250 mg tablets) once daily
Other Name: ZYTIGA
- Change in radiographic progression free survival (rPFS) [ Time Frame: During study period (up to 3 years) ]rPFS in subjects with BRCA1, BRCA2, or ATM qualifying gene mutations defined as the time from randomization to radiographic progression by blinded independent central reader (BICR) using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria or death.
- Confirmed Objective Response Rate (ORR) by BICR [ Time Frame: During study period (up to 3 years) ]Confirmed ORR by BICR in subjects with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria
- Time to Pain progression [ Time Frame: To be completed by subject daily for 7 consecutive days before each respective 4-week visit/assessment date with Day 1 as the baseline visit date (not required to be at site) ]Time to pain progression defined as the time from randomization to increase in pain based on brief pain inventory (short form) question #3 and opioid analgesic usage
- Overall Survival (OS) [ Time Frame: During study period (up to 4 years) ]OS defined as time from randomization to death due to any cause
- rPFS [ Time Frame: During study period (up to 3 years) ]rPFS in subjects with HRR qualifying mutations defined as the time from randomization to radiographic progression by blinded independent central reader (BICR) using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria or death
- AEs/SAEs and Collection of clinical chemistry/hematology parameters [ Time Frame: From the time of signature of informed consent throughout the treatment period up to and including the 30-day follow-up period. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987543
|Contact: AstraZeneca Clinical Study Information Centerfirstname.lastname@example.org|
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|Principal Investigator:||Johann de Bono, M.D., Ph.D.||The Institute of Cancer Research, United Kingdom|
|Principal Investigator:||Maha Hussain, M.D., FACP, FASCO||Northwestern University, United States of America|