Standard Therapy with or without Local Treatment for Prostate Cancer

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

Recruiting Phase 2 Phase 3 Interventional Study
Prostate Cancer Oligometastasis Oligorecurrence Recurrent Prostate Cancer Metastatic Prostate Cancer De Novo Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
464 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for

This trial is looking for veterans with oligometastatic prostate cancer to see if combining standard therapy with local treatment improves outcomes. Participants will be assigned to one of the treatment groups and monitored over time.

Are You a Good Fit for This Trial?
Rules you out Castration-resistant prostate cancerSerious spinal cord issues

You may be able to join if

  • I am at least 18 years old.
  • I can provide informed consent.
  • I have a confirmed diagnosis of prostate cancer.
  • I have had prior local treatment for prostate cancer.
  • If I have recurrent cancer, I have suspicious PSA levels.
  • I had blood tests confirming my testosterone levels.
  • I have had scans of my abdomen and pelvis.
  • I have 1-10 lesions that could be cancer spread.

You may not be able to join if

  • I have castration-resistant prostate cancer.
  • I have had other cancers unless fully treated and in remission.
  • I have symptomatic metastasis needing immediate treatment.
  • I have brain metastases or serious spinal issues.
  • I have had public radiation therapy that rules me out.
  • I cannot have local therapy due to my past treatments.
  • I have any condition that might interfere with treatment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 clinica…
Trial Locations
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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 p…
Contacts

Abhishek Solanki, MD MS

(708) 202-8387

Abhishek.Solanki@va.gov

CONTACT