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ACTIVE NOT RECRUITING

NCT05668351

Stereotactic Ablative Radiation Therapy for Prostate Cancer

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

Summary

This single arm trial will investigate a novel way to plan and deliver SABR for prostate cancer. Prostate-directed SABR will be high-dose SABR (40 Gy in 5 fractions) with central sparing of the urethra and peripheral sparing of the rectum and pudendal arteries (SUPR-SABR). This study tests the hypothesis that genitourinary (GU) and gastrointestinal (GI) toxicity rates following SUPR-SABR are comparable to (or possibly lower than) historical GU and GI toxicity rates following standard SABR (stSABR) with 36.25 Gy in the treatment of low- and intermediate-risk prostate cancer.

Official title: Phase II Trial of Sparing the Urethra, Pudendal Artery and Rectum During Stereotactic Ablative Body Radiotherapy (SUPR-SABR) for Low and Intermediate Risk Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-05-12

Completion Date

2028-01-15

Last Updated

2026-02-19

Healthy Volunteers

Conditions

Prostate Cancer

Interventions

RADIATION

SUPR-SABR treatment

SUPR-SABR prescription dose to the PTV\_4000 will be 8 Gy per fraction for five fractions. The prescription dose to PTV\_3625 will be a minimum of 7.25 Gy per fraction for five fractions. SABR will be delivered 2-3 times a week, every other day. There will be a minimum of 40 hours between fractions and maximum of 128 hours between fractions.

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male patients aged 18 years and older 4. In good general health as evidenced by medical history to be a candidate for curative-intent prostate cancer treatment 5. Ability to receive pelvic radiotherapy and be willing to adhere to the SUPR-SABR regimen 6. Previously untreated prostate cancer (with cytotoxic chemotherapy, surgical or radiation therapy) 7. Localized adenocarcinoma of the prostate with the following features: 1. cT1-T2c 2. PSA\<20 * Patients receiving a 5-alpha reductase inhibitor must have a PSA \<10 3. Grade Group 1-3 8. Patient willing and able to complete the EPIC questionnaire at time of registration and 1-, 12-, and 24- months post treatment 9. Prostate volume \<120 cc 10. History and physical including a digital rectal exam 90 days prior to registration 11. ECOG performance status 0-2 12. Be eligible and willing to undergo MRI prostate and pelvis as a component of RT planning 13. Bone and soft tissue imaging as clinically indicated (for unfavorable intermediate risk or symptomatic patients only) within 120 days prior to registration 14. IPSS score ≤20 at time of initial history and physical with treating radiation oncologist Exclusion Criteria: 1. Female patients (due to lack of prostate gland) 2. Concurrent use of testosterone supplementation 3. Known homozygous for ATM pathogenic mutation 4. Prior pelvic RT 5. Treatment with another investigational drug for prostate cancer 6. Pre-existing conditions or overall health status which disqualifies the patient from curative-intent RT 7. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years 8. Patients with distant metastases from prostate cancer 9. Patients with lymph node involvement by prostate cancer 10. Prior prostatectomy, cryotherapy, high-intensity focused ultrasound, pelvic irradiation overlapping with fields needed for prostate cancer treatment, prostate brachytherapy, or previous cytotoxic chemotherapy for prostate cancer 11. Unwilling or unable to provide informed consent

Locations (1)

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, United States