Recruiting
Phase 2

Abiraterone & Enzalutamide

Sponsor:

Sun Pharmaceutical Industries Limited

Code:

NCT05422911

Conditions

Metastatic Cancer

Neoplasm, Prostate

Castrate-sensitive

Castrate-sensitive Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abiraterone acetate

Apalutamide

Enzalutamide

Study Details

Brief 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

Study ID

NCT05422911

Start date

Aug 31, 2022

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Abiraterone Acetate

active comparator: Standard of Care

Interventions

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

Apalutamide

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

Enzalutamide

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tito Fojo, MD, PhD

718-584-9000antonio.fojo@va.gov

Adrienne A Perea, MPH

718-584-9000adrienne.perea@va.gov

Locations

VA Greater Los Angeles Healthcare System

Recruiting

Los Angeles, California, United States, 90073

Contacts

Matthew B Rettig, MD

Matthew.Rettig@va.gov

Samantha M Tran

Samantha.Tran@va.gov

James A. Haley Veterans Administration Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

Terrence Grady, D.O., Ph.D.

terrence.grady@va.gov

Lisa A Braun

Lisa.Braun2@va.gov

VA Ann Arbor Healthcare System

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Phoebe A Tsao, MD

Phoebe.Tsao@va.gov

Laura A Randolph

Laura.Randolph@va.gov

VA St. Louis Health Care System

Recruiting

St Louis, Missouri, United States, 63106

Contacts

Eric M Knoche, MD

Eric.Knoche@va.gov

Carley Browning

Carley.Browning@va.gov

VA New York Harbor Healthcare System

Recruiting

New York, New York, United States, 10010

Contacts

Victor Adorno Febles, MD

Victor.AdornoFebles@va.gov

Sarah K Loh

Sarah.Loh2@va.gov

James J. Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

Contacts

Tito Fojo, MD, PhD

718-584-9000antonio.fojo@va.gov

Francesca Smith

Francesca.Smith@va.gov

VA Hudson Valley Health Care System

Recruiting

Wappingers Falls, New York, United States, 12590

Contacts

Ponciano L Reyes, MD

ponciano.reyes@va.gov

Christina M. Sportiello

Christina.Sportiello@va.gov

W.G. Bill Hefner Medical Center

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

Michael M Goodman, MD

Michael.Goodman2@va.gov

Hillary N Vanskiver

hillary.vanskiver@va.gov

VA Portland Health Care System

Recruiting

Portland, Oregon, United States, 97239

Contacts

Julie Graff, MD

Julie.Graff@va.gov

Abigail K Prager

Abigail.Prager@va.gov

Corporal Michael J. Crescenz VA Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Yu-Ning Wong, MD, MSCE

Yu-Ning.Wong@va.gov

Shraddha Patel

Shraddha.Patel2@va.gov

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dr. Aihua E. Yen, MD

Aihua.yen@va.gov

Shannie S Oben

Shannie.oben@va.gov

VA Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

Robert B Montgomery, MD

Robert.Montgomery@va.gov

Kara Flaherty

Kara.Flaherty@va.gov

More Information

Sponsor

Sun Pharmaceutical Industries Limited

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • YONSA
  • zytiga
  • enzalutamide
  • apalutamide
  • growth rate
  • doubling time

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sun Pharmaceutical Industries Limited on 2026-06-15.