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

NCT06990542 | Recruiting Phase 2 DMC

• 1 other identifier: 812494
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  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).

  3 months

Study Arms (2)

Standard of care dose radiotherapy

NO INTERVENTION

Standard dose radiation therapy

Tumor-focused radiotherapy

EXPERIMENTAL

Image-guided tumor-focused radiation therapy

Radiation: Image-guided tumor-focused radiation therapy

Interventions

Image-guided tumor-focused radiation therapy RADIATION

Image-guided tumor-focused radiation therapy

Tumor-focused radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Veracyte, Inc.: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tyler Seibert, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler Seibert, MD, PhD

CONTACT

(858) 822-5354; cancerCTO@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)