Image-guided tumor-focused radiotherapy for intermediate- and high-risk prostate cancer
RAdiation Dose TAiloRing Guided by Enhanced Targeting
This trial will test whether giving higher, tumor-targeted radiation while lowering dose to the rest of the prostate reduces urinary and bowel side effects for people with intermediate- or high-risk prostate cancer receiving curative radiotherapy (with or without systemic therapy).
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT06990542 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men with histologically confirmed intermediate- or high-risk prostate adenocarcinoma who have a lesion visible on prostate MRI or PSMA PET and are planning definitive radiotherapy are ideal candidates.
Not a fit: Patients without an MRI- or PSMA-detected focal lesion, those with prior prostatectomy or prior prostate-directed treatments, or those with bilateral hip implants that interfere with imaging/planning may not receive benefit.
Why it matters
Potential benefit: If successful, this approach could lower short-term and long-term urinary and bowel side effects and improve quality of life without compromising cancer control.
How similar studies have performed: Previous trials of MRI-guided focal boosting (for example, FLAME and other focal-boost studies) have shown promising oncologic outcomes, but randomized evidence specifically demonstrating reduced toxicity remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
La Jolla, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.