Image-guided tumor-focused radiotherapy for intermediate- and high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, non-blinded phase II trial compares image-guided, tumor-focused radiotherapy to standard whole-prostate radiotherapy in men with intermediate- or high-risk prostate cancer. Tumor targets are identified using prostate MRI and/or PSMA PET and then receive an intensified focal radiation dose while the remainder of the prostate receives a de-escalated dose. The study measures acute and late genitourinary and gastrointestinal toxicity, plus overall survival, metastasis-free survival, quality of life, and exploratory biomarkers. The intent is to maintain excellent cancer control while reducing radiation exposure to nearby organs and thereby lowering treatment-related toxicity.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Diego
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Tyler Seibert, MD, PhD — University of California, San Diego
• Study coordinator: Tyler Seibert, MD, PhD
• Email: cancerCTO@health.ucsd.edu
• Phone: (858) 822-5354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.