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NCT04787744PHASE2, PHASE3RECRUITING

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

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)

Sponsor: VA Office of Research and Development

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Prostate Cancer, Oligometastasis, Oligorecurrence, Recurrent Prostate Cancer, Metastatic Prostate Cancer
Interventions
PET-directed Local Therapy using Surgery, PET-directed Local Therapy using Radiation, Salvage Local Therapy for locally recurrent disease, Goserelin, Histrelin, Leuprolide & Triptorelin
Enrollment
464 participants
Primary completion
Sep 2026
Study completion
Mar 2029
First posted
Mar 2021
Last updated
Apr 2026

Primary Endpoints (CT.gov)

Castration-resistant prostate cancer-free survival (CRPC-free survival)

Time frame: 4 years

Secondary Endpoints

Radiographic progression-free survival (rPFS)

Clinical progression-free survival (cPFS)

Freedom from index lesion progression (FFILP)

Eligibility Criteria

Inclusion Criteria: Age 18 years. Ability to provide Informed Consent for participation in the study ECOG Performance Status 2 at time of enrollment. Prostate cancer, confirmed histologically or cytologically. If original documentation of histology and cytology are not available, documentation of prostate cancer satisfies these criteria. If recurrent, prior curative-intent local therapy to all sites of prostate cancer with either upfront radiotherapy or prostatectomy with or without post-operative radiotherapy. If recurrent, PSA suspicious for biochemical recurrence after local therapy, with lab value(s) taken prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST, and meeting one of the three below categories: PSA 0.2 ng/ml x 2 after prostatectomy +/- post-operative radiotherapy; Elevation of PSA 2 ng/ml above the nadir after definitive radiotherapy; Or Two consecutively elevated PSAs with evidence of metastasis on the

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov