SBRT After Prostatectomy for Prostate Cancer

(PLUTO-MPC Trial)

Overseen By Kerri Durrant

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Gross residual disease, Node +ve, Metastases, Prior pelvic radiotherapy, 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: Unknown

Duration: 6-8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a precise form of treatment in prostate cancer patients who have had surgery and still show signs of cancer. The goal is to see if this method can effectively treat the cancer with fewer treatments and less impact on healthy tissue. This newer method has shown promising outcomes with minimal side effects for prostate cancer treatment.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment SBRT after prostatectomy for prostate cancer?

Research shows that SBRT (a precise form of radiation therapy) is effective in controlling prostate cancer recurrence after surgery, with studies indicating it can manage local cancer recurrence and has a favorable safety profile. ^{1 2 3 4 5}

Is SBRT safe for treating prostate cancer?

SBRT (Stereotactic Body Radiation Therapy) is generally considered safe for treating prostate cancer, with studies showing low rates of severe side effects. Some patients may experience mild to moderate urinary and gastrointestinal symptoms, but serious long-term adverse effects are rare. ^{4 6 7 8 9}

How is SBRT different from other treatments for prostate cancer after prostatectomy?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers highly focused radiation in fewer sessions compared to traditional radiation therapy, which may help minimize damage to surrounding healthy tissues and organs. This approach is still being studied for its safety and effectiveness in treating prostate cancer after surgery. ^{2 3 5 10 11}

Research Team

Chia-Lin Tseng, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for men with prostate cancer who've had surgery to remove the prostate but have rising PSA levels, indicating potential cancer activity. They must not have any visible remaining disease, no spread to lymph nodes or distant areas, and no previous pelvic radiation. Participants should be able to fill out health questionnaires.

Inclusion Criteria

Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA

Completed written informed consent

I had surgery to remove my prostate due to adenocarcinoma.

Exclusion Criteria

Gross residual disease (per conventional imaging, i.e. CT and/or MRI)

I cannot have intense pelvic radiation due to certain health conditions.

My cancer has spread to nearby lymph nodes or other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Body Radiotherapy (SBRT) post-prostatectomy

6-8 weeks

Follow-up

Participants are monitored for safety, efficacy, and quality of life after treatment

6.5 years

Treatment Details

Interventions

• SBRT

Trial Overview The study is examining the safety and effectiveness of a targeted form of radiation therapy called SBRT for prostate cancer patients after they've undergone surgery (prostatectomy). The focus is on those with localized cancer and increasing PSA levels post-surgery.

Participant Groups

Group I: Men with prostate cancer post-prostatectomy Experimental Treatment 1 Intervention

Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

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?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Royal Victoria Regional Health Centre

Collaborator

Trials

3

Recruited

1,400+

Princess Margaret Hospital, Canada

Collaborator

Trials

121

Recruited

40,000+

Credit Valley Hospital

Collaborator

Trials

3

Recruited

430+

Findings from Research

In a study of 26 patients with low- or intermediate-risk prostate adenocarcinoma, stereotactic body radiation therapy (SBRT) showed excellent biochemical control with no observed failures after a median follow-up of 59.5 months.

The treatment resulted in manageable late toxicity, with only 11.5% of patients experiencing significant genitourinary or gastrointestinal side effects, and patient-reported quality of life remained stable compared to pre-treatment levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate Stereotactic Body Radiation Therapy With a Focal Simultaneous Integrated Boost: 5-Year Toxicity and Biochemical Recurrence Results From a Prospective Trial. Maas, JA., Dobelbower, MC., Yang, ES., et al.[2023]

Salvage stereotactic body radiation therapy (SBRT) for localized prostate cancer recurrence shows promising efficacy, with 2-year recurrence-free survival rates ranging from 40% to 76% across five studies involving 265 participants.

While genitourinary toxicity was more common than gastrointestinal issues, the rates of severe complications were relatively low, with grade 2 complications ranging from 5% to 22% and no grade 3 gastrointestinal complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvage stereotactic body radiation therapy for locally recurrent prostate cancer following primary radiation therapy, are benefits worth toxicity risks?: A systematic review. Bray, G., Bahadori, A., Rama, D.[2023]

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 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]

Stereotactic ablative radiotherapy (SABR) is a safe and effective treatment for low and intermediate risk prostate cancer, with only a 2.25% failure rate observed in a study of 400 patients over a median follow-up of 15 months.

The treatment resulted in a significant decline in prostate-specific antigen (PSA) levels, with no severe late adverse effects reported, indicating that SABR could be considered for more advanced cases of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients Miszczyk, L., Namysł Kaletka, A., Napieralska, A., et al.[2020]

Stereotactic body radiation therapy (SBRT) was administered to 16 patients with isolated prostate cancer recurrence, resulting in a significant biochemical response in 15 out of 16 patients at a median follow-up of 10 months.

The treatment was well tolerated, with only one patient experiencing mild acute toxicity, indicating that SBRT is a safe option for managing isolated recurrences in the prostatic bed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic radiotherapy for isolated recurrence in the prostatic bed. Detti, B., Bonomo, P., Masi, L., et al.[2018]

References

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

Prostate Stereotactic Body Radiation Therapy With a Focal Simultaneous Integrated Boost: 5-Year Toxicity and Biochemical Recurrence Results From a Prospective Trial. [2023]

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

Single-fraction image-guided robotic radiosurgery efficiently controls local prostate cancer recurrence after radical prostatectomy. [2022]

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

Salvage stereotactic body radiation therapy for locally recurrent prostate cancer following primary radiation therapy, are benefits worth toxicity risks?: A systematic review. [2023]

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

A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for Locally Advanced Prostate Cancer. [2023]

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

Preliminary Analysis of a Phase II Trial of Stereotactic Body Radiation Therapy for Prostate Cancer With High-Risk Features After Radical Prostatectomy. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical characteristics and management of late urinary symptom flare following stereotactic body radiation therapy for prostate cancer. [2022]

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

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

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

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

9. Thailand pubmed.ncbi.nlm.nih.gov

Cyberknife Radioablation of Prostate Cancer – Preliminary Results for 400 Patients [2020]

10. Ireland pubmed.ncbi.nlm.nih.gov

Prostate bed and organ-at-risk deformation: Prospective volumetric and dosimetric data from a phase II trial of stereotactic body radiotherapy after radical prostatectomy. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

CyberKnife stereotactic radiotherapy for isolated recurrence in the prostatic bed. [2018]