This phase III trial compares the effect of stereotactic body radiation therapy (SBRT) with neurovascular (NV) sparing to standard of care SBRT without NV sparing on patient-reported sexual function in patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Sometimes after radiation therapy, patients may experience problems that affect the urinary and bowel systems, along with sexual function. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Neurovascular sparing is a technique that uses images, such as computed tomography (CT) or magnetic resonance imaging (MRI), to map the NV bundles of nerves and blood vessels, which are crucial for erectile function. Adapting the radiation therapy treatment, with NV sparing, may enable a more precise delivery of radiation that is customized on the patient's internal anatomy immediately before the treatment starts. Giving NV sparing SBRT may be more effective than standard of care SBRT without NV sparing in prevention nerve damage and preserving erectile function in patients with localized prostate adenocarcinoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07293585.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Active
Contact: Amar Kishan
Phone: 310-825-6577
PRIMARY OBJECTIVE:
I. To determine whether NV-sparing SBRT to the prostate reduces the proportion of patients experiencing patient-reported sexual function decline when compared to standard of care SBRT to the prostate without explicit NV-sparing.
SECONDARY OBJECTIVES:
I. To determine whether there are differences in acute or chronic changes in another patient-reported measure of sexual function (Sexual Health Inventory for Men [SHIM] score) following NV-sparing SBRT versus conventional SBRT.
II. To determine whether there are differences in other domains of patient reported quality of life (QOL) by Expanded Prostate Cancer Index Composite (EPIC)-26 (urinary, bowel) following NV-sparing SBRT versus conventional SBRT.
III. To determine whether there are differences in acute or late physician-scored genitourinary (GU)/gastrointestinal (GI) toxicity by Common Terminology Criteria for Adverse Events (CTCAE) following NV-sparing SBRT versus conventional SBRT.
IV. To determine the prostate specific antigen (PSA) complete response at 2 years, defined as proportion of patients with PSA < 20% of the pre-SBRT PSA.
V. To determine whether there are differences in the 5-year biochemical recurrence-free survival following NV-sparing SBRT versus conventional SBRT.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo CT-guided or MRI-guided SBRT without explicit NV sparing every other day or on consecutive days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
ARM II: Patients undergo CT-guided or MRI-guided SBRT with NV sparing approach every other day or on consecutive days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed at 1, 3, 6, 9, 12, 24, 36, 48 and 60 months.
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorAmar Kishan
