NCT05422911

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_2

Timeline
17mo left

Started Aug 2022

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Aug 2022Dec 2027

First Submitted

Initial submission to the registry

June 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 31, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

5.3 years

First QC Date

June 9, 2022

Last Update Submit

June 10, 2026

Conditions

Metastatic CancerNeoplasm, ProstateCastrate-sensitiveCastrate-sensitive Prostate Cancer

Keywords

YONSAzytigaenzalutamideapalutamidegrowth ratedoubling time

Outcome Measures

Primary Outcomes (2)

  • Tumor growth rate (g)

    Tumor growth rate (g)

    2 years

  • Testosterone levels

    Testosterone levels to assess testosterone suppression with androgen deprivation therapy (ADT).

    2 years

Secondary Outcomes (1)

  • PSA Response

    2 years

Study Arms (2)

Abiraterone Acetate

ACTIVE COMPARATOR
Drug: Abiraterone acetate

Standard of Care

ACTIVE COMPARATOR
Drug: ApalutamideDrug: Enzalutamide

Interventions

Abiraterone acetateDRUG

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

Also known as: YONSA®, ZYTIGA®, generic ZYTIGA
Abiraterone Acetate
ApalutamideDRUG

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

Also known as: ERLEADA®
Standard of Care
EnzalutamideDRUG

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

Also known as: XTANDI®
Standard of Care

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

RECRUITING

James A. Haley Veterans Administration Hospital

Tampa, Florida, 33612, United States

RECRUITING

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

RECRUITING

VA St. Louis Health Care System

St Louis, Missouri, 63106, United States

RECRUITING

VA New York Harbor Healthcare System

New York, New York, 10010, United States

RECRUITING

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

VA Hudson Valley Health Care System

Wappingers Falls, New York, 12590, United States

RECRUITING

W.G. Bill Hefner Medical Center

Salisbury, North Carolina, 28144, United States

RECRUITING

VA Portland Health Care System

Portland, Oregon, 97239, United States

RECRUITING

Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm MetastasisProstatic Neoplasms

Interventions

Abiraterone Acetateapalutamideenzalutamide

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Tito Fojo, MD, PhD

CONTACT

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

Adrienne A Perea, MPH

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The investigators have used clinical trial data and real-world data including national VHA data to successfully demonstrate how even in the real-world, estimated growth rate (g) values accurately predict OS. This study will test the growth rate (g) endpoint prospectively.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 21, 2022

Study Start

August 31, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(12)