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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSun Pharmaceutical Industries Limited

About this trial

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.

Eligibility criteria

Qualifiers

Be willing and able to provide written informed consent for the trial.

Age ≥18 years of age on day of signing informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).

Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.

Disqualifiers

Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).

Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization.

History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).

Patients who are receiving any other investigational agents concurrently.

Trial design

Treatments tested in this trial

  • Abiraterone acetate
  • Apalutamide
  • Enzalutamide

Treatment groups

192 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Pharmaceutical Industries Limited

Lead sponsor

VA Puget Sound Health Care System

Collaborator

VA Greater Los Angeles Healthcare System

Collaborator

James A. Haley Veterans Administration Hospital

Collaborator

VA New York Harbor Healthcare System

Collaborator

VA Ann Arbor Healthcare System

Collaborator

Corporal Michael J. Crescenz VA Medical Center

Collaborator

W.G. Bill Hefner Medical Center

Collaborator

Portland VA Medical Center

Collaborator

Michael E. DeBakey VA Medical Center

Collaborator

VA St. Louis Health Care System

Collaborator

VA Hudson Valley HealthCare System

Collaborator