SUPR-SABR Treatment for Prostate Cancer

(SUPR-SABR Trial)

Overseen By Jasmin Brooks

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Testosterone supplementation

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1-2 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for prostate cancer, called SUPR-SABR. The goal is to determine if this method causes fewer side effects, such as urinary and digestive issues, compared to traditional treatment. It delivers a higher dose of radiation while protecting critical areas like the urethra and rectum. Men with low- or intermediate-risk prostate cancer who have not undergone previous treatments like surgery or radiation may be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future prostate cancer treatments.

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 prior data suggests that this method is safe for prostate cancer treatment?

Research has shown that SABR (Stereotactic Ablative Body Radiotherapy) is generally safe and well-tolerated for prostate cancer. One study found that administering 40 Gy of SABR in 5 sessions was feasible and resulted in few additional side effects, with most participants experiencing only minor issues.

Another study examined a slightly higher dose of 45 Gy in 5 sessions and also demonstrated promising safety, indicating that patients tolerated it well. However, further research is needed to confirm these findings over a longer period.

In summary, current evidence suggests that SABR, even at higher doses, is safe for treating prostate cancer. Prospective participants should discuss any concerns with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SUPR-SABR treatment for prostate cancer because it offers a promising advancement over standard radiation therapy. Unlike traditional approaches, which typically deliver a uniform radiation dose, SUPR-SABR administers a higher dose of 40 Gy in just five sessions, with targeted precision that spares critical areas like the rectum, urethra, and pudendal artery. This precision allows for an increased therapeutic dose beyond the standard 36.25 Gy, potentially improving cancer control and reducing the chance of relapse. This approach could lead to better outcomes and fewer side effects for patients, making it a compelling option for prostate cancer treatment.

What evidence suggests that SUPR-SABR treatment might be an effective treatment for prostate cancer?

Research shows that SUPR-SABR, an advanced radiation therapy, holds promise for treating prostate cancer. In this trial, participants will receive a prescription dose of 40 Gy in 5 sessions. Studies have found this regimen to be feasible and generally well-tolerated, with few additional side effects. SUPR-SABR targets the cancer more precisely while protecting critical areas like the urethra and rectum. Previous findings suggest that this method could control prostate cancer more effectively than standard treatments. Additionally, this therapy is convenient and cost-effective, making it an appealing choice for patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Harriet Eldredge-Hindy, MD

Principal Investigator

MUSC Department of Radiation Oncology

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SUPR-SABR treatment

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.

How Is the Trial Designed?

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 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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043737/

Stereotactic ablative body radiotherapy in patients with ... 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850025001511

Clinician- and Patient-Reported Outcomes of Stereotactic ... Conclusions. SABR delivering 40 Gy in 5 fractions is feasible and well-tolerated for high-risk prostate cancer, with minimal additional toxicity ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.779182/full

Dose-Intensified Stereotactic Ablative Radiation for ... Purpose: Stereotactic ablative radiation (SAbR) has been increasingly used in prostate cancer (PCa) given its convenience and cost efficacy.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06325046?term=John

Adaptive Radiation Therapy (ART) Stereotactic Ablative ... Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2763312

Outcomes of Observation vs Stereotactic Ablative ... Conclusions and Relevance Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02353819

Stereotactic Ablative Radiotherapy (SABR) of Pelvis and ... Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and ...