This phase II trial studies how well stereotactic ablative radiation therapy (SABR) using adaptive radiation techniques for sparing the urethra, pudendal artery, and rectum (SUPR) works in treating patients with low- or intermediate-risk prostate cancer. SABR uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. This study will use a new method of radiation planning created to protect the normal, healthy tissues including the bladder, urethra, rectum, and blood vessels in men with low- or intermediate-risk prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05668351.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Harriet B Eldredge-Hindy
Phone: 843-792-6382
PRIMARY OBJECTIVE:
I. To evaluate the 12-month patient reported genitourinary (GU) and gastrointestinal (GI) toxicity of SUPR-SABR.
SECONDARY OBJECTIVES:
I. To further evaluate the toxicity profile of SUPR-SABR based on:
Ia. 24-month Expanded Prostate Cancer Index Composite (EPIC) urinary and bowel domain scores (patient reported);
Ib. Incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher safety events (physician reported);
Ic. 1-month patient reported GU toxicity.
II. To evaluate 12- and 24-month erectile function as assessed by the Sexual Health Inventory for Men (SHIM) score.
III. To evaluate the clinical efficacy and biochemical failure rate in prostate cancer patients treated with SUPR-SABR.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To relate changes in erectile function to radiotherapy dose to the pudendal artery.
OUTLINE:
Patients undergo SUPR-SABR in 5 fractions every other day, 2-3 times per week over 2 weeks. Patients undergo foley catheter placement during simulation on visit 1 and endorectal balloon placement during visits 1-6. Patients undergo magnetic resonance imaging (MRI) and computed tomography (CT) during simulation on visit 1 and may undergo MRI, CT, or positron emission tomography (PET) at suspected disease progression during follow-up visits 7-11.
After completion of study treatment, patients are followed-up at 1-, 6-, 12-, 18-, and 24-months post -radiotherapy and then every 6 months for years 2-5 and annually after year 5.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorHarriet B Eldredge-Hindy
