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

Conditions

• Castrate-sensitive
• Castrate-sensitive Prostate Cancer
• Metastatic Cancer
• Neoplasm, Prostate

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Abiraterone acetate — DRUG
  YONSA® (fine particle formulation 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 \[unless the Veteran has had prior bilateral orchiectomy\]. Note that in the first four months the YONSA® dose should not exceed 500 mg administered orally once daily. ZYTIGA® (abiraterone acetate) or generic ZYTIGA 1000 mg (four 250 mg uncoated tablets or two 500 mg film-coasted tablets) administered orally once daily in combination with prednisone 5 mg administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].
• Apalutamide — DRUG
  Apalutamide (ERLEADA®), 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 (XTANDI®), 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 and uniform across the US. 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, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.

Key Dates

First listed

Jun 21, 2022

Start date

Aug 31, 2022

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

192 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Tumor growth rate (g) [ Time Frame: 2 years ]

Central Contacts

• Tito Fojo, MD, PhD
  718-584-9000
  [email protected]
• Adrienne A Perea, MPH
  718-584-9000
  [email protected]

Locations (12)

Find similar trials in Los Angeles, CA

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