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Comparing standard therapy with or without PET-directed local therapy for prostate cancer in veterans

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)

Phase2; Phase3 Interventional VA Office of Research and Development · NCT04787744

This study is testing if adding a specific local treatment to standard therapy can help veterans with prostate cancer live longer without their cancer getting worse.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment464 (estimated)
Ages18 Years and up
SexMale
SponsorVA Office of Research and Development Federal
Drugs / interventionsradiation, chemotherapy
Locations20 sites (Long Beach, California and 19 other locations)
Trial IDNCT04787744 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the effectiveness of standard systemic therapy (SST) with or without PET-directed local therapy in improving castration-resistant prostate cancer-free survival among veterans with oligometastatic prostate cancer. It is a multi-center, open-label, seamless phase II/III randomized trial that aims to determine if adding local therapy can enhance outcomes for patients who have a limited number of metastatic sites. The study will include patients who have previously undergone curative local therapy and are experiencing biochemical recurrence. Participants will be monitored for progression-free survival and overall survival rates.

Who should consider this trial

Good fit: Ideal candidates for this study are veterans aged 18 and older with confirmed oligometastatic prostate cancer who have previously received curative local therapy.

Not a fit: Patients with advanced metastatic prostate cancer beyond oligometastatic disease or those who have not undergone prior curative local therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment approach that significantly improves survival outcomes for veterans with oligometastatic prostate cancer.

How similar studies have performed: Previous studies have shown promising results for metastasis-directed therapy in oligometastatic prostate cancer, suggesting that this approach may be beneficial.

Eligibility criteria

Show full inclusion / exclusion 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 imaging Studies.

-Serum testosterone obtained prior to randomization based on one of the criteria below:

For patients who have a history of a prior episode of therapy with SST agents for prostate cancer, a total testosterone 100 ng/dl after completion of the prior episode of SST and before the start of current SST or within 30 days of starting current SST if the patient has already started SST for recurrence.

For patients who have no prior history of an episode of therapy with SST agents and have already started SST for recurrence, this pre-SST testosterone is not required.

CT or MRI abdomen/pelvis performed prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST. The results from the CT component of the PET/CT can be used to fulfill this criterion. This is optional for patients who have a PSMA PET/CT. Yechnetium (Tc99m-MDP) or sodium fluoride (NaF) bone scan (sodium fluoride preferred) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST. This is optional for patients who have a PSMA PET/CT. Prostate PET/CT (currently PSMA, Fluciclovine, choline) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST.

1-10 lesions suspicious for nodal recurrence or metastasis from prostate cancer as determined by the investigator based on the above imaging studies.

Has already undergone NPOP sequencing or a plan is in place for NPOP sequencing for prostate cancer.

For participants on SST at the time of enrollment only:

Has been on SST for 180 days. For participants with local recurrence after curative-intent local therapy on imaging :

Patients with local recurrence in the prostate, SV, or prostate bed are eligible as long as there is at least 1 nodal or distant metastatic recurrence. Biopsy must confirm local recurrence for patients who have had prior curative-intent radiation to the prostate, SV, or prostate bed.

Candidate for salvage local therapy (refer to Section 10.4) as determined by a urologist or radiation oncologist (depending on the respective modality to be used to treat the local recurrence).

For participants with de novo prostate cancer:

Candidate for prostate-directed radiation.

Exclusion Criteria:

* Any current or prior evidence of castration-resistant prostate cancer, defined as two consecutive rises in serum PSA, obtained at a minimum of 1-week interval, with the final PSA value \>/= 1 ng/ml, while having a total testosterone \< 50 ng/dl).
* Prior malignancy, except the following:

  * Adequately treated non-melanomatous skin cancer;
  * Adequately treated Stage 0, I, or II cancer from which the patient is currently in complete remission; or
  * Any other cancer from which the patient has been disease free for three years.
* Presence of a symptomatic metastasis that requires palliative radiotherapy.
* Any known brain metastases, presence of leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome.
* Prior nodal, bone, or visceral metastasis after curative-intent therapy other than those identified on the enrollment imaging studies which make the patient ineligible for PET-directed local therapy (per investigator discretion).
* Prior radiation therapy to any sites requiring PET-directed local therapy or salvage local therapy that will lead to prohibitively high risk of toxicity from subsequent local therapy, as determined by the treating radiation oncologist (if radiation is intended as the study local therapy) or surgeon/urologist (if surgery is intended as the study local therapy).
* Any other previous or current condition, which, in the judgement of the LSI, is likely to interfere with any STARPORT treatments or assessments.

Where this trial is running

Long Beach, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerOligometastasisOligorecurrenceRecurrent Prostate CancerMetastatic Prostate CancerDe Novo Prostate CancerMetastasisPET-directed local therapy
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.