Prostate Cancer Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California at Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Christy Palodichuk
cpalodichuk@mednet.ucla.edu
310-267-8988
Backup
Care Felix
cfelix@mednet.ucla.edu
310-825-9771
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2036-12-16
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center
Collaborators: Viewray Inc.

This content was sourced from clinicaltrials.gov