Stereotactic Ablative Radiation Therapy for Prostate Cancer

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Dec 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new method of delivering a type of radiation therapy called Stereotactic Ablative Radiation Therapy (SABR) for men with prostate cancer. The goal is to see if this new approach, known as SUPR-SABR, can reduce side effects related to the urinary and digestive systems compared to traditional SABR treatments. In this study, researchers will focus on giving a high dose of radiation while protecting nearby healthy tissues, specifically the urethra and rectum, to see if patients experience fewer complications.

To participate in this trial, men aged 18 and older with localized prostate cancer that has not been treated before may be eligible. Participants should be in good health and able to follow the treatment plan. They will need to complete some questionnaires about their health before starting the study and again at various times afterward. If you are interested in learning more or think you might qualify, it’s important to discuss this with your doctor, who can provide more details and help you understand if this trial is right for you.

Gender

MALE

Eligibility criteria

• 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