Recruiting
Phase 2

Tumor-Focused Radiotherapy

Sponsor:

UCLA

Code:

NCT06990542

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Image-guided tumor-focused radiation therapy

Study Details

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

Study ID

NCT06990542

Start date

Jun 9, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of care dose radiotherapy

Standard dose radiation therapy

experimental: Tumor-focused radiotherapy

Image-guided tumor-focused radiation therapy

Interventions

Image-guided tumor-focused radiation therapy

Image-guided tumor-focused radiation therapy

Primary outcome measure

  • Acute toxicity [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Tyler Seibert, MD, PhD

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

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Genitourinary Research Team

858-822-5354cancerCTO@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-17.