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 range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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