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RECRUITING Phase 2

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

NCT04787744 · View on ClinicalTrials.gov ↗

Study Summary

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

Interventions

  • PROCEDURE PET-directed Local Therapy using Surgery
  • RADIATION PET-directed Local Therapy using Radiation
  • OTHER Salvage Local Therapy for locally recurrent disease
  • DRUG Goserelin, Histrelin, Leuprolide & Triptorelin
  • DRUG ADT + Nilutamide, Flutamide, & Bicalutamide

Study Locations (20)

California

  • VA Long Beach Healthcare System, Long Beach, CA — Long Beach
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles

Wisconsin

  • William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison
  • Clement J. Zablocki VA Medical Center, Milwaukee, WI — Milwaukee

District of Columbia

  • Washington DC VA Medical Center, Washington, DC — Washington D.C.

Florida

  • Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines

Illinois

  • Edward Hines Jr. VA Hospital, Hines, IL — Hines

Indiana

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis

Maryland

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore

Massachusetts

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston

Trial Details

FieldValue
Enrollment Target 464 participants
Start Date 2021-07-01
Est. Completion 2029-03-30
Phase Phase 2

Sponsor

VA Office of Research and Development

1,863 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04787744

The ClinicalTrials.gov registry entry for NCT04787744 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 464 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions — of which PET-directed Local Therapy using Surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04787744 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Wisconsin, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04787744 about?

NCT04787744 is a clinical study titled "Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer". This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prost...

What is the current status of trial NCT04787744?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 464 participants. The study started on 2021-07-01. Estimated completion is 2029-03-30.

What conditions does trial NCT04787744 study?

This clinical trial studies the following conditions: Prostate Cancer, Metastatic Prostate Cancer, Recurrent Prostate Cancer, Oligometastasis, Oligorecurrence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04787744?

The interventions under investigation include: PET-directed Local Therapy using Surgery (PROCEDURE), PET-directed Local Therapy using Radiation (RADIATION), Salvage Local Therapy for locally recurrent disease (OTHER), Goserelin, Histrelin, Leuprolide & Triptorelin (DRUG), ADT + Nilutamide, Flutamide, & Bicalutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04787744?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04787744 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial