Stereotactic Ablative Radiation Therapy for Prostate Cancer (NCT05668351) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Stereotactic Ablative Radiation Therapy for Prostate Cancer
United States42 participantsStarted 2023-05-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male patients aged 18 years and older
✓. In good general health as evidenced by medical history to be a candidate for curative-intent prostate cancer treatment
✓. Ability to receive pelvic radiotherapy and be willing to adhere to the SUPR-SABR regimen
✓. Previously untreated prostate cancer (with cytotoxic chemotherapy, surgical or radiation therapy)
✓. Localized adenocarcinoma of the prostate with the following features:
✓. cT1-T2c
Exclusion criteria
✕. Female patients (due to lack of prostate gland)
✕. Concurrent use of testosterone supplementation
What they're measuring
1
12 month Expanded Prostate Cancer Index Composite (EPIC) genitourinary score
Timeframe: 12 months
2
12 month Expanded Prostate Cancer Index Composite (EPIC) gastrointestinal score
✕. Treatment with another investigational drug for prostate cancer
✕. Pre-existing conditions or overall health status which disqualifies the patient from curative-intent RT
✕. 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
✕. Patients with distant metastases from prostate cancer