High-dose radiation therapy for 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
NA · Medical University of South Carolina · NCT05668351
This study is testing a new way to give high-dose radiation therapy for prostate cancer to see if it can reduce side effects while still being effective for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Medical University of South Carolina (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05668351 on ClinicalTrials.gov |
What this trial studies
This trial investigates a new method of delivering stereotactic ablative body radiotherapy (SABR) for prostate cancer, focusing on high-dose treatment while sparing critical structures like the urethra and rectum. The approach involves administering 40 Gy in 5 fractions to patients with localized prostate cancer. The study aims to compare the rates of genitourinary and gastrointestinal toxicity from this new method to historical data from standard SABR treatments. By utilizing advanced imaging techniques, the trial seeks to enhance treatment precision and patient safety.
Who should consider this trial
Good fit: Ideal candidates include male patients aged 18 and older with localized adenocarcinoma of the prostate and specific clinical characteristics.
Not a fit: Patients with previously treated prostate cancer or those with advanced disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could reduce side effects associated with prostate cancer radiation therapy while maintaining effective cancer control.
How similar studies have performed: Previous studies have shown promising results with similar high-dose SABR approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina Hollings Cancer Center — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Harriet Eldredge-Hindy, MD — MUSC Department of Radiation Oncology
- Study coordinator: Alan Brisendine
- Email: brisend@musc.edu
- Phone: 843-792-6382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, stereotactic body radiation therapy, stereotactic ablative body radiotherapy, SBRT, SABR, pudendal artery