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Image-guided, Tumor-focused Radiotherapy for Prostate Cancer

This study is testing a new way to give radiation therapy for intermediate or high-risk prostate cancer. It compares "image-guided, tumor-focused radiation therapy" to the standard treatment that targets the whole prostate. Researchers believe that by focusing the radiation more precisely on the tumor, they can reduce the amount of radiation that reaches nearby organs. This might lead to fewer side effects, especially problems with your urinary and digestive systems. The main goal is to see if the new treatment causes less "acute toxicity" (side effects that happen soon after treatment) within three months. You may be able to join if you are at least 18 years old, have prostate cancer confirmed by a biopsy, and are planning to have radiation therapy. The study is currently recruiting 150 participants, but its overall status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be assigned by chance to receive either the new image-guided, tumor-focused radiation therapy or standard whole-prostate treatment. It is a Phase II study and is not blinded, so both you and your doctors will know which treatment you are receiving. The study plans to enroll 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Acute toxicity will be measured at 3 months. The study also plans to measure late genitourinary and gastrointestinal toxicity, but the timeframe for this is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06990542

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of California, San Diego
~150 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Image-guided tumor-focused radiation therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute toxicity
Measured over 3 months

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Tyler Seibert, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Tyler Seibert, MD, PhD
[email protected]
(858) 822-5354
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
At least 18 years old
Histologic confirmation of prostate adenocarcinoma with plan for curative-intent radiation therapy
Lesion visible on prostate Magnetic Resonance Imaging and/or Prostate-Specific Membrane Antigen Positron Emission Tomography-Computed Tomography (according to the treating physician) with concordant pathology from biopsy needle locations.
For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during the radiation therapy treatment and for at least 6 months afterward.

Exclusion

Bilateral hip implants
Prior prostatectomy
Prior prostate cancer treatment (for example, focal therapy). Note that participants who started hormone therapy within the 90 days prior to randomization are eligible, as long as study-compatible imaging was performed within the 4 months prior to starting the hormone therapy.
Prior radiation therapy to an area requiring treatment in the present study

What this trial measures

  • Acute toxicity3 months

    Acute any attribution genitourinary or gastrointestinal toxicity (grade 2 or higher), compared between randomized arms, defined as the percentage of patients with Common Terminology Criteria for Adverse Events genitourinary or gastrointestinal toxicity of grade 2 or higher within 3 months of completing radiation therapy. Based on the Common Terminology Criteria for Adverse Event, grade 1 is the lowest and grade 5 is the highest. Grade 5 represents the worst outcome (death).