Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06990542

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of California, San Diego

La Jolla, California, United States, 92093

Actively Recruiting

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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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Image-guided, Tumor-focused Radiotherapy Treatment in Intermediate and High-risk Prostate Cancer | DecenTrialz