SUPR-SABR Treatment for Prostate Cancer

(SUPR-SABR Trial)

Overseen By Alan Brisendine

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical University of South Carolina

Must not be taking: Testosterone supplementation

Disqualifiers: Female, ATM mutation, Prior pelvic RT, others

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. ^{1 2 3 4 5}

Is 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. ^{1 2 5 6 7}

How 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. ^{1 2 4 5 8}

Research Team

Harriet Eldredge-Hindy, MD

Principal Investigator

MUSC Department of Radiation Oncology

Eligibility 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.

Inclusion Criteria

I am a man aged 18 or older.

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Unwilling or unable to provide informed consent

I have had treatments like surgery, cryotherapy, or radiation for prostate cancer.

I have had radiation therapy to my pelvic area before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SUPR-SABR treatment with 40 Gy in 5 fractions, sparing the urethra, pudendal artery, and rectum

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of genitourinary and gastrointestinal toxicity

24 months

Regular visits as per protocol

Long-term follow-up

Participants' erectile function and biochemical failure rates are assessed at 24 months

24 months

Treatment Details

Interventions

• SUPR-SABR treatment (Radiation)

Trial Overview 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.

Participant Groups

Group I: SUPR-SABR treatment Experimental Treatment 1 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 Canada for the following indications:

Approved in Canada as SABR for:

• Prostate cancer
• Oligometastatic prostate cancer

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.

While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. Loblaw, A.[2021]

Stereotactic ablative radiation (SAbR) at a dose of 45 Gy in 5 fractions shows a promising safety profile for treating localized prostate cancer, with acute urinary and gastrointestinal toxicity rates of 20.4% and 7.3%, respectively, and low rates of late toxicity after 2 years.

The treatment demonstrated excellent efficacy, with a biochemical failure-free survival rate of 100% at 1 year and 98.7% at 2 years, indicating strong disease control outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. Chen, L., Gannavarapu, BS., Desai, NB., et al.[2022]

In a study of 84 low-risk prostate cancer patients treated with Stereotactic Ablative Body Radiotherapy (SABR), long-term quality of life (QOL) outcomes were generally positive, with a median follow-up of 50.8 months, although some patients reported declines in urinary (17.9%), bowel (26.2%), and sexual (37.5%) QOL domains.

Dosimetric factors such as rectal D1cc and penile bulb V35 were identified as significant predictors of worse QOL, highlighting the importance of adhering to strict dosimetric constraints to minimize side effects from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. Elias, E., Helou, J., Zhang, L., et al.[2018]

In a study comparing two different fractionation schedules of stereotactic ablative radiotherapy (SABR) for prostate cancer, the 2-fraction treatment (26 Gy/2) showed significantly better quality of life (QOL) outcomes in the bowel domain compared to the 5-fraction treatment (40 Gy/5), with a lower rate of clinically important changes in bowel function.

Both treatment groups had low five-year biochemical failure rates (3.3% for 2-fraction and 4.6% for 5-fraction), indicating that the 2-fraction SABR is not only effective but also well tolerated, warranting further randomized trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. Alayed, Y., Quon, H., Cheung, P., et al.[2020]

CyberKnife stereotactic ablative radiotherapy (SABR) for treating intermediate- to very-high-risk prostate cancer showed a high 3-year biochemical relapse-free survival rate of 90.2%, indicating its efficacy in managing this condition.

The treatment was well-tolerated, with no patients experiencing severe toxicity (≥ grade 3), and only mild genitourinary and gastrointestinal side effects were reported, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. Fan, CY., Chao, HL., Huang, WY., et al.[2017]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

In a study of 152 men with intermediate risk prostate cancer, weekly stereotactic ablative radiotherapy (SABR) resulted in better short-term bowel and urinary quality of life compared to every other day treatment, but there were no significant differences in late toxicity or long-term quality of life outcomes after 62 months.

Both treatment regimens showed similar rates of biochemical failure and overall survival, indicating that while weekly SABR may reduce acute side effects, it does not compromise long-term efficacy or safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT). Alayed, Y., Quon, H., Ong, A., et al.[2021]

Stereotactic ablative body radiation (SABR) is a promising non-invasive treatment for localized prostate cancer, showing similar efficacy to brachytherapy in terms of disease control and lower side effects, making it a potentially safer option.

SABR is also more cost-effective and resource-efficient compared to traditional radiation techniques, but further well-powered studies are needed to confirm its benefits before it can be considered standard care, especially for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. Loblaw, A., Liu, S., Cheung, P.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Intensified Stereotactic Ablative Radiation for Localized Prostate Cancer. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Two versus five stereotactic ablative radiotherapy treatments for localized prostate cancer: A quality of life analysis of two prospective clinical trials. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy with CyberKnife in the treatment of locally advanced prostate cancer: preliminary results. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]

7. Ireland pubmed.ncbi.nlm.nih.gov

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]

8. China pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy in patients with prostate cancer. [2023]