Clinical trial · Interventional
Stereotactic Ablative 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
NCT05668351CI-TRIAL-00103617SUPR-SABRactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SUPR-SABR treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SUPR-SABR treatment
- description
- The prescription dose of this study will be 40 Gy in 5 fractions assigned to PTV\_4000 which permits sparing of the rectum, urethra and pudendal artery. There will be a secondary dose level of 36.25 Gy in 5 fractions. A minimum dose of 36.25 Gy will be given to the entire prostate PTV\_3625. 36.25 Gy in five fractions is currently endorsed as a standard of care for localized prostate cancer by the National Comprehensive Cancer Network guidelines in prostate cancer. Escalating the therapeutic radiation dose above 36.25 Gy provides potential for improved biochemical control of prostate cancer and decrease in relapse free survival.
- interventionNames
- Radiation: SUPR-SABR treatment
Primary outcomes (2)
- measure
- 12 month Expanded Prostate Cancer Index Composite (EPIC) genitourinary score
- timeFrame
- 12 months
- description
- EPIC score at 12 months post intervention will be compared with pre-intervention scores. Score scale is 0 to 100 with lower scores indicating more severe symptoms.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 consentReferences
Publications (0)
Data not yet available
No reference posted for this study.