Actively Recruiting
Veterans Affairs Seamless Phase II/III Randomized Trial of Standard Systemic Therapy With or Without PET-directed Local Therapy for Oligorecurrent Prostate Cancer
Led by VA Office of Research and Development · Updated on 2026-04-08
464
Participants Needed
20
Research Sites
130 weeks
Total Duration
On this page
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 PET/CT 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 180 days
Participants will receive standard systemic therapy (SST) for their prostate cancer. Those in the experimental group will also receive PET-directed local therapy to all metastases using surgery or radiation, and if applicable, prostate-directed radiation or radical prostatectomy for primary or locally recurrent tumors. Treatment plans are tailored using shared decision-making between the physician and participant.
Visits scheduled according to treatment regimen; may include multiple visits for systemic therapy and local therapy procedures
Duration - Up to 4 years
After completing treatment, participants will be monitored to assess disease progression, survival outcomes, and quality of life over time.
Scheduled follow-up visits over 4 years for assessments and monitoring
Trial Site Locations
Total: 20 locations
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
2
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Actively Recruiting
3
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States, 20422-0001
Actively Recruiting
4
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States, 33744
Actively Recruiting
5
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
Actively Recruiting
6
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Actively Recruiting
7
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Actively Recruiting
9
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
10
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Active, Not Recruiting
11
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128-2226
Terminated
12
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, United States, 07018
Terminated
13
VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010-5011
Terminated
14
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Actively Recruiting
15
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Actively Recruiting
16
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19104-4551
Actively Recruiting
17
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Actively Recruiting
18
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
Actively Recruiting
19
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705-2254
Actively Recruiting
20
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-1000
Actively Recruiting
Research Team
A
Abhishek Solanki, MD MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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