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

Summary

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.

Conditions

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

Interventions

DRUG

Abiraterone acetate

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 \[unless the Veteran has had prior bilateral orchiectomy\].

DRUG

Apalutamide

Apalutamide (ERLEADA®), 240 mg (four 60 mg tablets) administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].

DRUG

Enzalutamide

Enzalutamide (XTANDI®), 160 mg (four 40 mg capsules) administered orally once daily + physician's choice GnRH agonist/antagonist \[unless the Veteran has had prior bilateral orchiectomy\].

Sponsors & Collaborators

• VA Puget Sound Health Care System

  collaborator FED

• VA Greater Los Angeles Healthcare System

  collaborator FED

• James A. Haley Veterans Administration Hospital

  collaborator FED

• VA New York Harbor Healthcare System

  collaborator FED

• VA Ann Arbor Healthcare System

  collaborator FED

• Corporal Michael J. Crescenz VA Medical Center

  collaborator FED

• W.G. Bill Hefner Medical Center

  collaborator FED

• Portland VA Medical Center

  collaborator FED

• Michael E. DeBakey VA Medical Center

  collaborator FED

• VA St. Louis Health Care System

  collaborator FED

• VA Hudson Valley HealthCare System

  collaborator UNKNOWN

• Sun Pharmaceutical Industries Limited

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-31

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations