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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up Men only

Radiation tailored to protect the blood vessels and nerves that support erections

Official title: Vascular Optimized Radiotherapy Tuned to Critical Structures for Erectile Function Using High-Precision X-Ray Treatment

Run by Jonsson Comprehensive Cancer Center · NCT07293585 · Data updated 2026-11-12

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.

More Prostate Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment200 (estimated)
SponsorJonsson Comprehensive Cancer Center
Academic / other
Drugs / interventionsradiation
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedDecember 16, 2025
Main results expectedDecember 16, 2035
Study endsDecember 16, 2036
Registry record updatedDecember 19, 2025
Trial IDNCT07293585 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of California at Los Angeles
    Los Angeles, California, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.