RecruitingPhase 2 / Phase 3

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for Veterans with prostate cancer that has spread to 1–10 spots. It compares standard whole-body drug treatment alone with the same treatment plus treatment aimed at spots found on PET scans. Researchers want to see whether added treatment delays cancer that keeps growing despite treatment to lower testosterone.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed prostate cancer with 1–10 spots of spread, as judged by the study doctor.
  • Be able to give informed consent, meaning you understand and agree to join. The study team will check age and daily activity requirements.
  • If cancer has returned, have had surgery or radiation meant to cure it, and have PSA blood test results that suggest it has returned.
  • Have the required PET scan and, when needed, other scans and testosterone blood tests within the study’s time limits.
  • Have completed, or have a plan for, NPOP testing to look for gene changes in the cancer.
  • If already taking whole-body drug treatment, meet the study’s rules about how long you have taken it.
  • If cancer has returned near the prostate, also have spread to a lymph node or a distant site and be able to receive more local treatment. A tissue sample must confirm local return after prior radiation.
  • If prostate cancer is newly diagnosed, be able to receive radiation aimed at the prostate.

Who can't join

  • Have or have ever had prostate cancer that keeps growing despite very low testosterone, based on the study’s blood test rules.
  • Have had another cancer, unless it was adequately treated non-melanoma skin cancer, treated stage 0–II cancer now fully gone, or another cancer that has been absent for three years.
  • Have a spot of cancer spread causing symptoms that needs radiation for relief.
  • Have cancer spread to the brain or the tissue covering the brain and spinal cord, or cancer pressing on the spinal cord or nerves at its base.
  • Have earlier spread to lymph nodes, bones, or organs that makes PET-guided local treatment unsuitable, as judged by the study doctor.
  • Have had radiation that would make more treatment to a needed site too risky.
  • Have another past or current condition that the study doctor thinks would interfere with study treatment or testing.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (20)

CA

DC

FL

IL

IN

MA

MD

MI

MN

MO

NC

NJ

NY

OH

PA

TX

VA

WI