Actively Recruiting
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc
Led by VA Office of Research and Development · Updated on 2025-12-31
60
Participants Needed
4
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.
CONDITIONS
Official Title
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, 18 years of age or older
- Written informed consent provided
- Diagnosed with prostate adenocarcinoma
- Metastatic disease confirmed by bone scan, PET scan, CT, or MRI
- At least one metastasis showing PSMA avidity greater than liver on 18F-DCFPyL scan
- Progressive castration-resistant prostate cancer with serum testosterone below 50 ng/mL and evidence of PSA or radiographic progression
- Prior use of a novel androgen receptor signaling inhibitor for at least 4 weeks
- ECOG performance status grade 0-2
- Up to 10 detectable metastases on molecular imaging amenable to radiation
- Life expectancy of at least 6 months
- Adequate organ function including blood counts, liver enzymes, and kidney function
- Agreement to use contraception during treatment and for 120 days after last dose
You will not qualify if you...
- Presence of visceral metastases including liver or brain (lung metastases allowed)
- Small cell or neuroendocrine carcinoma histology
- Anti-cancer therapies completed less than 2 weeks before study start (4 weeks for investigational agents)
- Unrecovered toxicities from previous treatments above grade 1
- Prior radiotherapy within 2 weeks of study treatment or unresolved radiation toxicities
- Major surgery within 4 weeks prior to therapy without adequate recovery
- Active infection requiring antibiotics
- Symptomatic local recurrence after prior curative therapy
- Other active malignancy needing treatment within 24 months except certain skin or urothelial cancers
- Psychiatric or substance abuse disorders interfering with study participation
- Planning to father children during study and 120 days after last treatment
- Current or impending spinal cord compression or need for urgent palliative radiation therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003
Actively Recruiting
2
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
Actively Recruiting
3
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Actively Recruiting
4
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Actively Recruiting
Research Team
N
Nicholas G Nickols, MD PhD
CONTACT
M
Matthew B Rettig, MD
CONTACT
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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