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

NCT07293585 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: 25-2129
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

sexual function

Outcome Measures

Primary Outcomes (1)

• Expanded Prostate Cancer Index Composite (EPIC-26) sexual function Questionnaire

  The primary endpoint is clinically relevant (≥24 point) decline in EPIC-26 sexual function domain scores at 24 months following treatment in patients randomized to NV-sparing SBRT relative to patients randomized to conventional SBRT without explicit NV-sparing.

  24 months

Secondary Outcomes (7)

• Clinically relevant acute change in International Prostate Symptom Score (I-PSS) domain of EPIC-26.

  From initiation to 90 days post treatment

• Clinically relevant acute change in Sexual Health Inventory for Men (SHIM) domain of EPIC-26.

  From initiation to 90 days post treatment

• Clinically relevant chronic changes in IPSS, of EPIC-26.

  From initiation to 90 days post treatment

• Clinically relevant chronic changes in SHIM, of EPIC-26.

  From initiation to 90 days post treatment

• Gastric ulcer (GU) or Gastriointestinal (GI) toxicity

  From initiation to 90 days post treatment

Study Arms (2)

Arm 1 non-adaptive SBRT

ACTIVE COMPARATOR

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.

Radiation: Neurovascular sparing stereotactic body radiation therapy

Arm 2 Neurovascular sparing stereotactic body radiation therapy

EXPERIMENTAL

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.

Radiation: Neurovascular sparing stereotactic body radiation therapy

Interventions

Neurovascular sparing stereotactic body radiation therapy RADIATION

Use of adaptive radiotherapy

Arm 1 non-adaptive SBRT; Arm 2 Neurovascular sparing stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate is required to treat
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18.
• Histologically confirmed, clinically localized adenocarcinoma of the prostate.
• 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.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Ability to undergo magnetic resonance angiography (MRA) of the pelvis.
• No indication for urgent or emergent radiation.
• Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.

You may not qualify if:

• Patients with neuroendocrine or small cell carcinoma of the prostate.
• 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.
• Evidence of intraprostatic lesion by biopsy, MRI, or PSMA PET/CT within the middle third, or both lateral thirds of the prostate gland.
• History of whole-gland cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate.
• Prior pelvic radiotherapy.
• History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.
• Penile prosthesis or implant present prior to treatment.

Sponsors & Collaborators

• Viewray Inc.: collaborator
• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90045, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Amar Kishan, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Palodichuk

CONTACT

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

Care Felix

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: magnetic resonance angiography (MRA) guided active aid in identifying and avoiding internal pudendal arteries, corpora cavernosa and neurovascular bundles sensitive structures during SBRT.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 19, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 16, 2035
• Study Completion (Estimated): December 16, 2036
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)