RECRUITING

Stereotactic Ablative Radiation Therapy for Prostate Cancer

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Conditions

Prostate Cancerstereotactic body radiation therapystereotactic ablative body radiotherapySBRTSABRpudendal artery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

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

Quick Facts

Study Start:2023-05-12
Study Completion:2026-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05668351

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male patients aged 18 years and older
  4. 4. In good general health as evidenced by medical history to be a candidate for curative-intent prostate cancer treatment
  5. 5. Ability to receive pelvic radiotherapy and be willing to adhere to the SUPR-SABR regimen
  6. 6. Previously untreated prostate cancer (with cytotoxic chemotherapy, surgical or radiation therapy)
  7. 7. Localized adenocarcinoma of the prostate with the following features:
  8. 1. cT1-T2c
  9. 2. PSA\<20
  10. * Patients receiving a 5-alpha reductase inhibitor must have a PSA \<10
  11. 3. Grade Group 1-3
  12. 8. Patient willing and able to complete the EPIC questionnaire at time of registration and 1-, 12-, and 24- months post treatment
  13. 9. Prostate volume \<120 cc
  14. 10. History and physical including a digital rectal exam 90 days prior to registration
  15. 11. ECOG performance status 0-2
  16. 12. Be eligible and willing to undergo MRI prostate and pelvis as a component of RT planning
  17. 13. Bone and soft tissue imaging as clinically indicated (for unfavorable intermediate risk or symptomatic patients only) within 120 days prior to registration
  18. 14. IPSS score ≤20 at time of initial history and physical with treating radiation oncologist
  1. 1. Female patients (due to lack of prostate gland)
  2. 2. Concurrent use of testosterone supplementation
  3. 3. Known homozygous for ATM pathogenic mutation
  4. 4. Prior pelvic RT
  5. 5. Treatment with another investigational drug for prostate cancer
  6. 6. Pre-existing conditions or overall health status which disqualifies the patient from curative-intent RT
  7. 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. 8. Patients with distant metastases from prostate cancer
  9. 9. Patients with lymph node involvement by prostate cancer
  10. 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. 11. Unwilling or unable to provide informed consent

Contacts and Locations

Study Contact

Alan Brisendine
CONTACT
843-792-6382
brisend@musc.edu
Jasmin Brooks
CONTACT
brooksjm@musc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Medical University of South Carolina

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-12
Study Completion Date2026-01-15

Study Record Updates

Study Start Date2023-05-12
Study Completion Date2026-01-15

Terms related to this study

Keywords Provided by Researchers

  • stereotactic body radiation therapy
  • stereotactic ablative body radiotherapy
  • SBRT
  • SABR
  • pudendal artery

Additional Relevant MeSH Terms

  • Prostate Cancer