SUPR-SABR Treatment for Prostate Cancer (SUPR-SABR Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByHarriet Eldredge-Hindy, MD
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a new high-dose radiation treatment for men with low- and intermediate-risk prostate cancer. The treatment aims to protect important nearby areas like the urethra, rectum, and certain arteries. It uses precise imaging and positioning to focus radiation on the prostate while reducing side effects.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot use testosterone supplements or be on another investigational drug for prostate cancer during the trial.
What data supports the effectiveness of the SUPR-SABR treatment for prostate cancer?
Research shows that stereotactic ablative radiotherapy (SABR) is promising for treating localized prostate cancer, with studies indicating it is well-tolerated and potentially cost-effective. However, more data is needed to confirm its long-term safety and effectiveness, especially for high-risk patients.
12345Is SUPR-SABR treatment generally safe for humans?
Stereotactic Ablative Radiation Therapy (SABR), also known as SUPR-SABR, has been used for prostate cancer and other conditions, showing promising results in tumor control. However, some serious complications have been reported, and strategies to reduce these risks are important for safe treatment.
12567How is SUPR-SABR treatment different from other prostate cancer treatments?
SUPR-SABR (Stereotactic Ablative Radiation Therapy) is a high-precision, non-invasive radiation treatment that delivers high doses of radiation in fewer sessions compared to traditional methods, potentially reducing side effects and treatment costs. It is particularly appealing for prostate cancer due to its ability to deliver effective doses similar to brachytherapy with less resource use and better quality of life outcomes in the short term.
12458Eligibility Criteria
Men over 18 with untreated, localized prostate cancer (cT1-T2c, PSA<20 or <10 if on certain medications, Grade Group 1-3) and in good health can join. They must be able to undergo specific MRI scans for treatment planning and have a prostate volume less than 120 cc. Those with prior treatments for prostate cancer or other pelvic malignancies, distant metastases from prostate cancer, lymph node involvement by the disease, or severe urinary symptoms are excluded.Participant Groups
The trial is testing SUPR-SABR—a high-dose radiation therapy targeting the prostate while sparing surrounding areas like the urethra and rectum. It aims to see if this method reduces side effects compared to standard SABR in treating low- and intermediate-risk prostate cancer.
1Treatment groups
Experimental Treatment
Group I: SUPR-SABR treatmentExperimental Treatment1 Intervention
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.
SUPR-SABR treatment is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as SABR for:
- Prostate cancer
- Oligometastatic prostate cancer
- Recurrent hormone-sensitive oligometastatic prostate cancer
🇪🇺 Approved in European Union as SABR for:
- Prostate cancer
- Oligometastatic prostate cancer
🇨🇦 Approved in Canada as SABR for:
- Prostate cancer
- Oligometastatic prostate cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Medical University of South Carolina Hollings Cancer CenterCharleston, SC
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
References
Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]Stereotactic ablative radiotherapy (SABR) is a relatively novel form of high precision radiotherapy. For low- and intermediate risk patients, ultrahypofractionation (UHF - more than 5 Gy per day) has been compared to conventionally fractionated or moderately hypofractionated radiotherapy in two large randomized studies. A third smaller randomized study examined the question of the optimal frequency of treatments. The results of these studies will be reviewed. SABR for high risk prostate cancer has been shown to be feasible and is well tolerated with careful planning and setup techniques. However, there is currently insufficient data supporting its use for high-risk patients to offer SABR outside of a clinical trial. SABR costs less to the radiotherapydepartments and, the patient, as well as increasing system capacity. Therefore, it has the potential to be widely adopted in the next few years.
Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]Stereotactic ablative radiation (SAbR) has been increasingly used in prostate cancer (PCa) given its convenience and cost efficacy. Optimal doses remain poorly defined with limited prospective comparative trials and long-term safety/efficacy data at higher dose levels. We analyzed toxicity and outcomes for SAbR in men with localized PCa at escalated 45 Gy in 5 fractions.
Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]Initial results of Stereotactic Ablative Body Radiotherapy (SABR) in the treatment of localized prostate cancer appear promising however long-term quality of life (QOL) outcomes and dosimetric correlates are necessary.
Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. [2020]Stereotactic ablative radiotherapy (SABR) is appealing for prostate cancer (PCa) due to low α/β, and increasing the dose per fraction could improve the therapeutic index and lead to a better quality of life (QOL). Here we report the outcomes of a QOL comparison between two phase II clinical trials: two vs. five fraction prostate SABR.
Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]Recent clinical reports of stereotactic ablative radiotherapy (SABR) in the treatment of low-risk prostate cancer have been encouraging. Our study evaluates the efficacy and safety of SABR using the CyberKnife system for treating intermediate- to very-high-risk prostate cancer.
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]The clinical applications of stereotactic body radiotherapy or stereotactic ablative radiotherapy (SABR) for the treatment of primary and metastatic tumours of different organ sites have been expanding rapidly in the recent decade. SABR requires advanced technology in radiotherapy planning and image guidance to deliver a highly conformal ablative dose precisely to targets (or tumours) in the body. Although this treatment modality has shown promising results with regard to tumour control, some serious complications have been observed and reported. In order to achieve a favourable therapeutic ratio, strategies to mitigate the risk of complications must be in place. This overview will summarise the reported serious complications caused by SABR and strategies to mitigate the risk will be discussed.
Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT). [2021]Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023]Prostate is the most common non-cutaneous cancer diagnosed among men in North America. Fortunately most prostate cancers are screen detected and non-metastatic on diagnosis. Treatment options for men with localized prostate cancer include surgery ± postoperative radiation or radiation ± androgen deprivation therapy (ADT). Brachytherapy ± external beam radiation treatment (EBRT) appears to have superior long-term disease control over EBRT alone likely because of higher biologic effective dose delivered. Stereotactic ablative body radiation (SABR) is a novel, non-invasive, high-precision EBRT technique that allows safe delivery of biologic doses similar to brachytherapy with similar or lower side effects [measured using toxicity or quality of life (QOL) scales]. Efficacy for SABR appears to be similar to brachytherapy including positive biopsy rates 2-3 years post treatment, biochemical failure (BF) rates out to 10-year and incidence of metastases. SABR dose escalation reduces biopsy positivity and prostate-specific antigen (PSA) nadirs but increases genitourinary (GU) and gastrointestinal (GI) toxicity-no effect on BF has been realized yet. The overall treatment time (OTT) varies in many protocols. Phase 2 randomized data shows that QOL is better in the acute setting with a weekly course of treatment compared to an every other day treatment regimen with no difference in late setting. Follow-up data are immature and likely underpowered to determine efficacy differences. SABR is cheaper and uses less resource than any other radiation technique. Given the healthcare resource challenges (including financial resources), SABR would be a welcomed addition if studies show non-inferiority to other radiation techniques. For patients with de novo or metastatic disease on relapse, there is much enthusiasm regarding the use of SABR in the setting of oligometastatic prostate cancer. SABR appears to be feasible to deliver, well tolerated and may delay the next line of therapy. However, until adequately powered randomized studies confirm a benefit, such an approach cannot be considered standard of care treatment at this time. Enrollment of eligible prostate cancer patients onto SABR clinical trials should be encouraged.