Stereotactic Ablative Radiation Therapy for Prostate Cancer

Description

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.

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

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

Stereotactic Ablative Radiation Therapy for Prostate Cancer

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical University of South Carolina,

Harriet Eldredge-Hindy, MD, PRINCIPAL_INVESTIGATOR, MUSC Department of Radiation Oncology

Study Record Dates

2026-01-15