Recruiting
Phase 3

SBRT with Neurovascular Sparing

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT07293585

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurovascular sparing stereotactic body radiation therapy

Study Details

Brief summary:

With people living longer after being treated for prostate cancer, quality of life has become a concern when considering the treatment plan. Sometimes after radiation therapy, patients may experience problems that affect the urinary and bowel systems, along with sexual function.

Stereotactic body radiotherapy (SBRT) is a type of radiation technique that delivers five high doses of radiation. At University of California at Los Angeles (UCLA), we have the option to administer SBRT in both our CT-guided and MRI-guided radiation machines.

This trial aims to determine the most effective method for protecting the nerves and blood vessels essential for erectile function, utilizing a technique known as neurovascular sparing.

This technique uses images (i.e., MRI) to map the neurovascular bundles of nerves and blood vessels, which are crucial for erectile function. "Adapting" the radiotherapy treatment for each of these five treatment sessions could enable a more precise delivery of your radiation treatment that is customized based on your internal anatomy immediately before the treatment starts. This is also a standard and low-risk intervention used in many different types of cancer. However, it is a very labor-intensive and time-consuming procedure that requires a team of experts to work together before each of your radiotherapy sessions. We are unsure if the increased complexity associated with this adaptive treatment reduces side effects.

Conditions

Prostate Cancer

Study ID

NCT07293585

Start date

Dec 16, 2025

Status verified date

Dec, 2025

Completion date

Dec 16, 2036

Anticipated

Primary completion date

Dec 16, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1 non-adaptive SBRT

Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or on consecutive days if necessary, for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.

experimental: Arm 2 Neurovascular sparing stereotactic body radiation therapy

Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or on consecutive days if necessary, for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.

Interventions

Neurovascular sparing stereotactic body radiation therapy

Use of adaptive radiotherapy

Primary outcome measure

  • Expanded Prostate Cancer Index Composite (EPIC-26) sexual function Questionnaire [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Christy Palodichuk

310-267-8988cpalodichuk@mednet.ucla.edu

Care Felix

310-825-9771cfelix@mednet.ucla.edu

Locations

University of California at Los Angeles

Recruiting

Los Angeles, California, United States, 90045

Contacts

Christy Palodichuk

310-794-2971cpalodichuk@mednet.ucla.edu

Care Felix

310-825-9771cfelix@mednet.ucla.edu

Principal Investigator:

Amar Kishan, MD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • sexual function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2025-12-19.