Radiation tailored to protect the blood vessels and nerves that support erections
Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray Treatment
This trial tests a tailored five‑session high‑precision radiation approach to better protect the nerves and blood vessels that help with erections in men getting radiation for localized prostate cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07293585 on ClinicalTrials.gov |
What this trial studies
Participants receive stereotactic body radiotherapy (SBRT) delivered in five high‑dose sessions using either CT‑guided or MRI‑guided machines, with treatment planning that fuses MRI/MRA to map neurovascular bundles and internal pudendal arteries. The trial applies a neurovascular‑sparing approach that crops these vascular and nerve structures out of the planning target volume and may adapt the plan for each fraction to limit dose to those organs at risk. The primary goal is to preserve erectile function while still delivering definitive radiation to localized prostate cancer. Eligible patients are adults with clinically localized prostate adenocarcinoma, no distant metastases, and who can undergo pelvic MRA.
Who should consider this trial
Good fit: Men with clinically localized prostate adenocarcinoma who are candidates for SBRT, have ECOG performance status ≤2, no distant metastases, and can undergo pelvic MRA are the ideal candidates.
Not a fit: Patients with metastatic disease, those unable to have MRI/MRA, those requiring urgent radiation, or patients with preexisting severe erectile dysfunction may not receive meaningful benefit.
Why it matters
Potential benefit: If successful, this approach could reduce radiation damage to the vessels and nerves that support erections and increase the chance of preserving sexual function after prostate radiotherapy.
How similar studies have performed: Early feasibility and dosimetric studies have shown neurovascular‑sparing and MRI‑guided adaptive radiotherapy can reduce dose to critical structures, but large randomized phase‑level evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18. 2. Histologically confirmed, clinically localized adenocarcinoma of the prostate. 3. Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping. a. Advanced imaging studies (i.e. prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first. 4. No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET/CT scan below the bifurcation of the renal arteries is allowable). 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 6. Ability to undergo magnetic resonance angiography (MRA) of the pelvis. 7. No indication for urgent or emergent radiation. 8. Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study. Exclusion Criteria: 1. Patients with neuroendocrine or small cell carcinoma of the prostate. 2. Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator. 3. Evidence of intraprostatic lesion by biopsy, MRI, or PSMA PET/CT within the middle third, or both lateral thirds of the prostate gland. 4. History of whole-gland cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate. 5. Prior pelvic radiotherapy. 6. History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia. 7. Penile prosthesis or implant present prior to treatment.
Where this trial is running
Los Angeles, California
- University of California at Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Amar Kishan, MD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Christy Palodichuk
- Email: cpalodichuk@mednet.ucla.edu
- Phone: 310-267-8988
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.