Actively Recruiting
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Led by VA Office of Research and Development · Updated on 2026-04-08
464
Participants Needed
20
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Age 18 years or older
- Able to provide informed consent
- ECOG performance status 2 or better at enrollment
- Histologically or cytologically confirmed prostate cancer
- If recurrent, prior curative local therapy with radiation or prostatectomy
- Biochemical recurrence with PSA criteria met before starting standard systemic therapy
- Serum testosterone 100 ng/dl after prior therapy or not required if no prior therapy
- Required imaging (CT/MRI, bone scan, and PET/CT) within 90 days before enrollment
- 1 to 10 metastatic or nodal lesions on imaging as determined by investigator
- Completed or planned tumor DNA sequencing (NPOP sequencing)
- On standard systemic therapy for at least 180 days if enrolled while on treatment
- For local recurrence, biopsy confirmed and candidate for salvage local therapy
- For de novo prostate cancer, candidate for prostate-directed radiation
You will not qualify if you...
- Evidence of castration-resistant prostate cancer (two rising PSA values ≥1 ng/ml with testosterone <50 ng/dl)
- Prior malignancies except treated non-melanoma skin cancer, early-stage cancers in remission, or cancers disease-free for 3 years
- Symptomatic metastases requiring palliative radiation
- Brain metastases, leptomeningeal disease, spinal cord compression, or cauda equina syndrome
- Prior metastases after curative therapy not eligible for PET-directed local therapy
- Prior radiation therapy to sites planned for PET-directed or salvage local therapy causing high toxicity risk
- Any condition interfering 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
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here