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New trial aims to delay prostate cancer progression with targeted local therapy

NCT ID NCT04787744

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study for veterans with prostate cancer that has returned in a few spots (oligorecurrence) compares standard systemic therapy alone versus standard therapy plus PET-directed local treatment using surgery or radiation. The goal is to see if adding local therapy delays the cancer from becoming resistant to hormone therapy. About 464 participants will be enrolled across multiple VA centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PET-directed local therapy (surgery or radiation)
What this could lead to
If successful, this approach could help men with recurrent prostate cancer delay the need for stronger hormone therapy and maintain a better quality of life for longer.
What could go wrong
This is a mid-stage trial, so results are not yet proven. Adding local therapy may increase side effects without improving outcomes, and the benefit may vary depending on the number and location of metastases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 464 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma Neoplasm Metastasis prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

De novo prostate cancer Metastatic prostate cancer Oligometastasis Oligorecurrence Prostate cancer Recurrent prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Bay Pines VA Healthcare System, Pay Pines, FL

    RECRUITING

    Bay Pines, Florida, 33744, United States

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    RECRUITING

    Milwaukee, Wisconsin, 53295-1000, United States

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4551, United States

  • Durham VA Medical Center, Durham, NC

    RECRUITING

    Durham, North Carolina, 27705, United States

  • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

    TERMINATED

    East Orange, New Jersey, 07018, United States

  • Edward Hines Jr. VA Hospital, Hines, IL

    RECRUITING

    Hines, Illinois, 60141-3030, United States

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    RECRUITING

    Richmond, Virginia, 23249, United States

  • Kansas City VA Medical Center, Kansas City, MO

    TERMINATED

    Kansas City, Missouri, 64128-2226, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    RECRUITING

    Houston, Texas, 77030, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    ACTIVE_NOT_RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

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

    RECRUITING

    Indianapolis, Indiana, 46202-2884, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

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

    RECRUITING

    Boston, Massachusetts, 02130, United States

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    RECRUITING

    West Los Angeles, California, 90073, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    RECRUITING

    Long Beach, California, 90822, United States

  • VA NY Harbor Healthcare System, New York, NY

    TERMINATED

    New York, New York, 10010-5011, United States

  • Washington DC VA Medical Center, Washington, DC

    RECRUITING

    Washington D.C., District of Columbia, 20422-0001, United States

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    RECRUITING

    Madison, Wisconsin, 53705-2254, United States

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