Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
AstraZeneca
Study ID
NCT02987543
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    300 mg (2x 150 mg tablets) twice daily
  • enzalutamide — DRUG
    160 mg (4 x 40 mg capsules) once daily
  • abiraterone acetate — DRUG
    1,000 mg (4 x 250 mg tablets) once daily
  • abiraterone acetate — DRUG
    1,000 mg (2 x 500 mg tablets) once daily
  • enzalutamide — DRUG
    160 mg (4 x 40 mg tablets) once daily

Study Details

The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

Key Dates

Start date
Feb 6, 2017
Status verified
Sep 2023
Primary completion
Jun 4, 2019
Completion
Feb 15, 2023

Study Design

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

Arms

  • Experimental: Olaparib
    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
  • Active Comparator: Enzalutamide OR abiraterone acetate
    Enzalutamide: Enzalutamide is available as capsules or tablets 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 or 500 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. Prednisolone is permitted for use instead of prednisone if necessary.

Primary Outcome Measure

Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only [ Time Frame: Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively). ]

Locations (35)

FacilityCityStateZIPSite coordinators
Research SiteAnchorageAlaska99503-
Research SiteTucsonArizona85704-
Research SiteTucsonArizona85741-
Research SiteDuarteCalifornia91010-
Research SiteSan DiegoCalifornia92161-
Research SiteSanta BarbaraCalifornia93105-
Research SiteWashington D.C.District of Columbia20007-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30318-
Research SiteChicagoIllinois60611-
Research SiteJeffersonvilleIndiana47130-
Research SiteNew OrleansLouisiana70112-
Research SiteBaltimoreMaryland21287-
Research SiteTowsonMaryland21204-
Research SiteOmahaNebraska68130-
Research SiteLas VegasNevada89135-
Research SiteAlbanyNew York12208-
Research SiteBrooklynNew York11201-
Research SiteSyracuseNew York13210-
Research SiteThe BronxNew York10468-
Research SiteDurhamNorth Carolina27710-
Research SiteSalisburyNorth Carolina28144-
Research SiteColumbusOhio43230-
Research SiteOklahoma CityOklahoma73104-
Research SiteSpringfieldOregon97477-
Research SiteTualatinOregon97062-
Research SiteCharlestonSouth Carolina29401-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteGermantownTennessee38138-
Research SiteNashvilleTennessee37232-
Research SiteSan AntonioTexas78229-
Research SiteSalt Lake CityUtah84112-
Research SiteSalt Lake CityUtah84148-
Research SiteSpokaneWashington99202-
Research SiteWheelingWest Virginia26003-

Find similar trials in Anchorage, AK

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Research Site· Anchorage, AKResearch Site· Tucson, AZResearch Site· Duarte, CAResearch Site· San Diego, CAResearch Site· Santa Barbara, CAResearch Site· Washington D.C., DC

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