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NCT04787744 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Prostate Cancer and Metastatic Prostate Cancer, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 464
- Enrollment target
- 20
- Study locations
NCT04787744: Recruiting Phase 2 study of Prostate Cancer and Metastatic Prostate Cancer, sponsored by VA Office of Research and Development.
NCT04787744 is a Phase 2 study of Prostate Cancer and Metastatic Prostate Cancer that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 464 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04787744, a Phase 2 study of Prostate Cancer and Metastatic Prostate Cancer, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 464 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
CRPC-free survival is a time-to-event outcome defined as the length of time from randomization to the first occurrence of failure. The following are forms of failure in the setting of a castrate testosterone level: PSA progression, radiographic progression, symptomatic skeletal event due to progression, and death.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 2 |
What NCT04787744 shows while recruiting
NCT04787744 is an interventional study that assigns participants to a tested intervention. The registered 464 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (24% lower).
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.
NCT04787744 names 20 study sites across 18 states, led by California, Wisconsin, District of Columbia.
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.
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).
Who is sponsoring clinical trial NCT04787744?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04787744's enrollment target sits among peer trials
464 121st of 735 higher than 615 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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