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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT07293585
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neurovascular sparing stereotactic body radiation therapy — RADIATION
    Use of adaptive radiotherapy

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Dec 2025
Primary completion
Dec 16, 2035
Completion
Dec 16, 2036

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California at Los AngelesLos AngelesCalifornia90045
Christy Palodichuk
[email protected]
310-794-2971
Care Felix
[email protected]
310-825-9771
Amar Kishan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California at Los Angeles· Los Angeles, CA

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