Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03732820
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    300 mg (2 x 150 milligrams (mg) tablets) twice daily
  • abiraterone acetate — DRUG
    1000 milligrams (mg) once daily

Study Details

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

Key Dates

Start date
Oct 31, 2018
Status verified
May 2026
Primary completion
Jul 30, 2021
Completion
Feb 5, 2027

Study Design

Enrollment
895 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: olaparib plus abiraterone
    Olaparib is available as a film-coated tablet containing 100 milligrams (mg) or 150 milligrams (mg) of olaparib. Subjects will be administered olaparib orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.
  • Placebo Comparator: placebo plus abiraterone
    Placebo to match olaparib is available as a film-coated tablet in 100 milligrams (mg) or 150 milligrams (mg). Subjects will be administered placebo orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.

Primary Outcome Measure

Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment [ Time Frame: Assessed from date of randomisation to data cut off (DCO1): 30Jul2021 (Approx. 2 years 9 months) ]

Locations (28)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35209-
Research SiteAnchorageAlaska99503-
Research SiteTucsonArizona85704-
Research SiteTucsonArizona85741-
Research SiteClovisCalifornia93611-
Research SiteLos AngelesCalifornia90027-
Research SiteLos AngelesCalifornia90073-
Research SiteSacramentoCalifornia95817-
Research SiteSan DiegoCalifornia92123-
Research SiteDenverColorado80211-
Research SiteLisleIllinois60532-
Research SiteJeffersonvilleIndiana47130-
Research SiteNew OrleansLouisiana70112-
Research SiteDetroitMichigan48202-
Research SiteGrand RapidsMichigan49503-
Research SiteSt LouisMissouri63106-
Research SiteBozemanMontana59715-
Research SiteOmahaNebraska68130-
Research SiteParamusNew Jersey07652-
Research SiteBrooklynNew York11220-
Research SiteNew Hyde ParkNew York11042-
Research SiteRochesterNew York14642-
Research SiteSyracuseNew York13210-
Research SiteDurhamNorth Carolina27710-
Research SitePhiladelphiaPennsylvania19111-
Research SiteCharlestonSouth Carolina29425-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Birmingham, ALResearch Site· Anchorage, AKResearch Site· Tucson, AZResearch Site· Clovis, CAResearch Site· Los Angeles, CAResearch Site· Sacramento, CA

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