Abiraterone, Enzalutamide, or Apalutamide in Castration-sensitive Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional study looks at three androgen receptor pathway inhibitors—abiraterone acetate, apalutamide, and enzalutamide—in men with metastatic, castration-sensitive prostate cancer. Real-world data from national VA records informed the framework, with eligibility including prior ADT and adequate organ function. The trial aims to observe safety and potential signals of effectiveness across these agents to guide future treatment decisions in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Veterans must meet the following to be eligible to participate:
* 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.
* Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).
* Laboratory tests meet minimum safety requirements:

  * Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) \[except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10X ULN\].
  * Renal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl
  * Hematological: Platelet count ≥100,000/mm\^3; Hemoglobin \>9 g/dL; ANC \>1 X10\^9/L
  * Serum potassium \>3 mEq/L

Exclusion Criteria:

Subjects with any of the following will not be enrolled:

* 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.
* Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.
* Child-Pugh Class B and C

Where it's running

• VA Greater Los Angeles Healthcare System
  Los Angeles, California, United States Recruiting
• James A. Haley Veterans Administration Hospital
  Tampa, Florida, United States Recruiting
• VA Ann Arbor Healthcare System
  Ann Arbor, Michigan, United States Recruiting
• VA St. Louis Health Care System
  St Louis, Missouri, United States Recruiting
• VA New York Harbor Healthcare System
  New York, New York, United States Recruiting
• James J. Peters VA Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Study coordinator: Tito Fojo, MD, PhD
• Email: antonio.fojo@va.gov
• Phone: 718-584-9000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.