SBRT for Prostate Cancer

Overseen By Tatiana Carvalho

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Fabio Cury

Must not be taking: Finasteride, Dutasteride, Chemotherapy, others

Disqualifiers: Invasive malignancy, Metastases, Surgery, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

12 Participants Needed

Trial Summary

What is the purpose of this trial?

It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment. Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel

Do I need to stop my current medications to join the trial?

The trial requires stopping finasteride at least 30 days before joining and dutasteride at least 90 days before joining. The protocol does not specify other medications, so check with the trial team for more details.

What data supports the idea that SBRT for Prostate Cancer is an effective treatment?

The available research shows that SBRT, also known as Stereotactic Ablative Radiotherapy (SABR), is promising for treating localized prostate cancer. Studies have shown that it can improve the quality of life for patients compared to traditional methods. For low- and intermediate-risk patients, SBRT has been compared to other types of radiotherapy in large studies, showing it to be effective and well-tolerated. Additionally, SBRT is less costly and can be completed in fewer sessions, making it a convenient option for patients. However, for high-risk patients, more research is needed before it can be widely recommended outside of clinical trials. ^{1 2 3 4 5}

What safety data exists for SBRT in prostate cancer treatment?

Safety data for SBRT in prostate cancer treatment includes findings from various studies. A phase II trial focused on toxicity validated the safety of SBRT with stringent dose constraints over three years. Phase III randomized trials have established the safety and efficacy of SBRT in localized prostate cancer, though data for node-positive cases is limited. Comparisons with IMRT show SBRT as a viable option with concerns about toxicity. Overall, SBRT is considered safe for localized prostate cancer, but optimal dosing and long-term safety at higher doses need further research. ^{6 7 8 9 10}

Is SBRT a promising treatment for prostate cancer?

Yes, SBRT is a promising treatment for prostate cancer because it offers a shorter treatment duration, is non-invasive, and is more effective at targeting tumor cells while minimizing damage to normal tissue. It is also cost-effective and can be more accessible in areas with limited radiation therapy centers. ^{7 11 12 13 14}

Research Team

Fabio Cury, MD

Principal Investigator

McGill University Health Centre- Cedars Cancer Centre

Eligibility Criteria

Men over 18 with low to favorable intermediate-risk prostate cancer, a recent PSA under 15 ng/dL, Gleason score of 6 or 7(3+4), and good performance status. They must not have had previous radical prostate treatments, hormonal therapies, or chemotherapy for prostate cancer and should be free from distant metastases and severe health conditions.

Inclusion Criteria

I have been mostly active and able to carry on all pre-disease activities without restriction recently.

I am older than 18 years.

Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria

My cancer has spread to distant parts of my body.

You have had prostate cancer treatment such as surgery, radiation therapy, or hormone therapy in the past.

I have been cancer-free for at least 5 years, except for non-melanoma skin cancer or in situ carcinoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

A gel is injected between the prostate and the rectum using a transrectal ultrasound, followed by a CT and MRI scan for treatment planning

1 week

2 visits (in-person)

Treatment

Participants receive a single fraction of SBRT with a hydrogel spacer and urinary catheter in place

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessment of GI and GU toxicity

3 months

Long-term follow-up

Participants are monitored for PSA control and late toxicity

5 years

Treatment Details

Interventions

• SBRT

Trial Overview The trial is testing a one-time Stereotactic Body Radiation Therapy (SBRT) treatment in patients who've had SpaceOAR hydrogel inserted to increase space between the prostate and rectum. It's a phase I study focusing on safety for those with specific types of early-stage prostate cancer.

Participant Groups

Group I: Single Fraction SBRT in the treatment of prostate cancer Experimental Treatment 1 Intervention

Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in European Union as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors
• Bone metastases

Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Fabio Cury

Lead Sponsor

Trials

1

Recruited

10+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

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 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]

A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.

The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. Siva, S., Bressel, M., Murphy, DG., et al.[2022]

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]

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]

A study involving 803 patients analyzed the quality of life (QOL) impacts of SBRT, IMRT, and brachytherapy for localized prostate cancer, showing that all treatments resulted in good QOL two years post-treatment.

SBRT demonstrated similar outcomes to IMRT in urinary and sexual domains, but showed a significant improvement in bowel symptoms compared to brachytherapy, suggesting it may be a safer option with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported quality of life after stereotactic body radiotherapy (SBRT), intensity modulated radiotherapy (IMRT), and brachytherapy. Evans, JR., Zhao, S., Daignault, S., et al.[2022]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed similar 5-year survival rates (90.8% for SBRT vs. 88.1% for IMRT) and comparable freedom from biochemical failure (FFBF) rates, indicating its efficacy is on par with intensity-modulated radiation therapy (IMRT).

Both treatment methods had low toxicity, with no severe (grade 3 or higher) side effects reported, suggesting that SBRT is a safe alternative that offers the benefits of shorter treatment duration and lower costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. Oliai, C., Bernetich, M., Brady, L., et al.[2022]

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 prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

Stereotactic body radiotherapy (SBRT) is shown to be safe and effective for treating node-positive prostate cancer, with a median follow-up of 30 months revealing no severe gastrointestinal toxicities and manageable genitourinary side effects.

In a study of 60 patients, SBRT resulted in a 3-year overall survival rate of 89% and a biochemical failure-free survival rate of 77%, indicating promising long-term outcomes even in patients with advanced disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. Telkhade, T., Murthy, V., Kanala, TS., et al.[2021]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed a high two-year biochemical relapse-free survival rate of 99%, indicating its efficacy in controlling the disease.

The treatment was well tolerated, with low rates of gastrointestinal (1%) and genitourinary (31%) toxicities, and most patients who were sexually potent before treatment maintained their potency two years later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. Chen, LN., Suy, S., Uhm, S., et al.[2022]

Stereotactic body radiotherapy (SBRT) for localized prostate cancer shows promising results, with studies indicating that ultra-hypofractionated schedules (like 42.7 Gy in 7 fractions) are non-inferior to standard treatments in terms of 5-year biochemical recurrence-free survival and have similar tolerability.

Current evidence suggests that two-fraction SBRT may be the shortest effective treatment schedule, but caution is advised against single-fraction SBRT due to concerns about inferior efficacy, highlighting the need for ongoing trials to determine optimal fractionation schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The march toward single-fraction stereotactic body radiotherapy for localized prostate cancer-Quo Vadimus? Ong, WL., Loblaw, A.[2023]

Stereotactic body radiotherapy (SBRT) shows a high local control rate of 98.1% in treating oligorecurrent prostate cancer limited to lymph nodes, based on a systematic review of 363 patients across nine studies with a median follow-up of 19.23 months.

The treatment demonstrated a low incidence of toxicity, with only 5.6% of patients experiencing grade ≥2 adverse effects, and no cases of grade 4 toxicity, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. Ponti, E., Lancia, A., Ost, P., et al.[2022]

Stereotactic body radiation therapy (SBRT) is a promising treatment for prostate cancer, offering a shorter treatment course and potentially more effective tumor cell killing compared to conventional radiation therapy, but long-term safety and efficacy data are still lacking.

Current studies show encouraging results for SBRT in terms of biochemical control and late toxicity, but due to limitations like short follow-up and small patient numbers, SBRT should only be used in clinical trials at this time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for prostate cancer: is the technology ready to be the standard of care? Zaorsky, NG., Studenski, MT., Dicker, AP., et al.[2013]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]

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

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

5. 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]

6. Ireland pubmed.ncbi.nlm.nih.gov

Patient-reported quality of life after stereotactic body radiotherapy (SBRT), intensity modulated radiotherapy (IMRT), and brachytherapy. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Propensity score matched comparison of SBRT versus IMRT for the treatment of localized prostate cancer. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ultra-hypofractionation in Node-positive Prostate Cancer. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

The march toward single-fraction stereotactic body radiotherapy for localized prostate cancer-Quo Vadimus? [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring All Avenues for Radiotherapy in Oligorecurrent Prostate Cancer Disease Limited to Lymph Nodes: A Systematic Review of the Role of Stereotactic Body Radiotherapy. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for prostate cancer: is the technology ready to be the standard of care? [2013]