Actively Recruiting
Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer
Led by University of California, San Diego · Updated on 2026-02-17
150
Participants Needed
1
Research Sites
442 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
V
Veracyte, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase II non-blinded randomized controlled trial of image-guided, tumor-focused radiotherapy in patients with intermediate- or high-risk prostate cancer planning to undergo definitive radiotherapy with or without systemic therapy. The image-guided, tumor-focused radiotherapy will be compared to standard, whole-prostate treatment. The investigators hypothesize that tumor-focused radiotherapy reduces the radiation dose to organs close to the prostate, possibly leading to decreased acute toxicity to the genitourinary and gastrointestinal organs. The investigators will measure acute and late genitourinary and gastrointestinal toxicity due to radiation and regardless of cause. The investigators will also measure overall survival, metastasis-free survival, and quality of life, as well as biomarkers that may help predict, in the future, who may have a worse toxicity following radiation therapy.
CONDITIONS
Official Title
Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and available for the study duration
- At least 18 years old
- Histologic confirmation of prostate adenocarcinoma with plan for curative-intent radiation therapy
- Lesion visible on prostate MRI and/or PSMA PET-CT with matching biopsy pathology
- For participants able to cause pregnancy: use effective contraception during radiation therapy and for at least 6 months afterward
You will not qualify if you...
- Bilateral hip implants
- Prior prostatectomy
- Prior prostate cancer treatment such as focal therapy (except hormone therapy started within 90 days prior to randomization with study-compatible imaging within 4 months before hormone therapy)
- Prior radiation therapy to the area planned for current treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Diego
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
T
Tyler Seibert, MD, PhD
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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