Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.

Part of paid clinical trials in The Bronx, New York.

Sponsor
James J. Peters Veterans Affairs Medical Center
Study ID
NCT05422911
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Cancer
  • Neoplasm, Prostate

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone acetate — DRUG
    YONSA® (abiraterone acetate), YONSA® 500 mg (four 125 mg tablets) or 625 mg (five 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].
  • Apalutamide — DRUG
    Apalutamide, 240 mg (four 60 mg tablets) administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].
  • Enzalutamide — DRUG
    Enzalutamide, 160 mg (four 40 mg capsules) administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].

Study Details

The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent, uniform across the US and indifferent to race. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively. But with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, African Americans with prostate cancer fared as well if not better than Caucasians and importantly had better outcomes with abiraterone, an observation needing further exploration as these therapies move up front.

Key Dates

Start date
Jun 30, 2022
Status verified
Jun 2022
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Abiraterone Acetate
  • Active Comparator: Standard of Care

Primary Outcome Measure

PSA Progression [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters VA Medical CenterThe BronxNew York10468
Tito Fojo, MD, PhD
[email protected]
718-584-9000

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By research site
James J. Peters VA Medical Center· The Bronx, NY

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