What is PET-directed local therapy studying for oligometastatic prostate cancer?

PET-directed local therapy is being studied to see if adding it to standard systemic therapy improves disease control for Veterans with oligometastatic prostate cancer. Researchers want to know if targeting metastases with surgery or radiation alongside systemic treatment helps delay cancer progression. The VA Office of Research and Development sponsors this trial to improve care options for Veterans.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 years and older with histologically confirmed prostate cancer and 1 to 10 metastatic sites may be eligible. Participants must be male and able to provide consent. They should have started or be candidates for standard systemic therapy and meet specific health and imaging criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive treatments and follow-up without charge during the trial.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

MALE

ID04787744

Phase IIIII VA Trial Comparing Standard Systemic Therapy With or Without PET-Guided Local Treatment for Men With Oligometastatic Prostate Cancer

Led by VA Office of Research and Development · Updated on 2026-04-08

464

Participants Needed

Research Sites

130 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding PET-directed local therapy to standard systemic therapy SST can improve castration-resistant prostate cancer-free survival for Veterans with oligometastatic prostate cancer. This condition involves having 1-10 metastatic sites, and the study focuses on both newly diagnosed and recurrent prostate cancer cases. The trial aims to assess if combining treatments can better control the disease compared to SST alone, and also explores differences in progression patterns, survival, quality of life, and the impact of tumor DNA mutations. Participants will be randomly assigned to receive SST alone or SST plus PET-directed local therapy. SST includes hormonal treatments such as androgen deprivation therapy and may involve chemotherapy or novel hormonal agents. PET-directed local therapy involves surgery or radiation to metastatic sites, and for some participants, treatment of the primary tumor or local recurrence using radiation, surgery, or other local therapies. Treatment choices are personalized through shared decision-making between the physician and Veteran. The study is designed as a seamless phase II to phase III trial conducted at multiple centers. During the study, Veterans will undergo imaging assessments including PETCT scans and bone scans, along with laboratory tests like PSA and testosterone levels. Researchers will monitor disease progression, survival, side effects, and patient-reported quality of life over several years. The primary outcome is castration-resistant prostate cancer-free survival measured at four years. Additional outcomes include progression-free survival, metastasis-free survival, prostate cancer-specific survival, overall survival, treatment toxicity, and health-related quality of life assessed through validated questionnaires. Participation involves regular follow-up visits for evaluations and monitoring throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Male aged 18 years or older
Ability to provide informed consent
Histologically or cytologically confirmed prostate cancer
ECOG Performance Status 2 or better at enrollment
If recurrent, prior curative local therapy with radiotherapy or prostatectomy
PSA suspicious for biochemical recurrence with specific PSA criteria
Serum testosterone levels meeting defined thresholds before randomization
Imaging showing 1-10 metastatic lesions on CT/MRI, bone scan, or PET/CT
Completed or planned next-generation prostate cancer sequencing (NPOP)
On standard systemic therapy (SST) for at least 180 days if already started
Candidates for salvage local therapy or prostate-directed radiation as appropriate

You will not qualify if you...

Evidence of castration-resistant prostate cancer
Prior malignancy except adequately treated skin cancer or certain cancers in remission for 3 years
Symptomatic metastasis requiring palliative radiotherapy
Known brain metastases, leptomeningeal disease, spinal cord compression, or cauda equina syndrome
Prior metastasis after curative therapy not eligible for PET-directed local therapy
Prior radiation therapy to sites planned for PET-directed or salvage local therapy with high toxicity risk
Any condition likely to interfere with study treatments or assessments as judged by the investigator

Research Team

Abhishek Solanki, MD MS

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Phase IIIII VA Trial Comparing Standard Systemic Therapy With or Without PET-Guided Local Treatment for Men With Oligometastatic Prostate Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria