SBRT After Prostatectomy for Prostate Cancer

(PLUTO-MPC Trial)

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a type of radiation therapy called SBRT (Stereotactic Body Radiotherapy) for men who have undergone surgery for prostate cancer. The researchers aim to determine if this treatment is safe and effective for those with localized cancer that may require additional treatment post-surgery. Men who have had prostate surgery and exhibit a rising PSA level (a protein produced by prostate cells) might be suitable candidates for this study. The goal is to discover improved methods for managing prostate cancer after surgery. As an unphased trial, this study provides a unique opportunity to advance prostate cancer treatment options.

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 prior data suggests that SBRT is safe for patients with localized prostate cancer post-prostatectomy?

Research has shown that stereotactic body radiotherapy (SBRT) is generally safe and feasible for prostate cancer patients. One study found that SBRT can be safely used in patients who have undergone other prostate surgeries, such as TURP (a procedure to remove part of the prostate), though these patients might experience more urinary side effects. Another study examined SBRT over a longer period and found that most patients tolerate it well.

For patients who have had their prostate removed, data remains limited. However, one analysis suggested that SBRT is safe enough to warrant further study. While more research is needed, the treatment appears promising without major safety concerns so far.

Overall, SBRT is considered to have manageable side effects, but results can vary for each individual. It is important to consult a healthcare provider to understand how these findings might relate to one's own health situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SBRT (Stereotactic Body Radiation Therapy) for prostate cancer post-prostatectomy because it represents a more precise approach to radiation therapy. Unlike traditional radiation treatments, which often involve multiple sessions over several weeks, SBRT delivers high doses of radiation in fewer sessions, targeting the cancer more accurately and potentially reducing damage to surrounding healthy tissues. This precision not only shortens the treatment timeline but may also lead to fewer side effects and improved quality of life for patients.

What evidence suggests that SBRT is effective for prostate cancer post-prostatectomy?

Research has shown that SBRT, a type of targeted radiation therapy, is a promising treatment for prostate cancer. In this trial, men with localized prostate cancer who have undergone prostatectomy will receive SBRT. Studies have found that SBRT is effective and generally manageable for these patients. One study found that SBRT controls cancer well with few side effects. Another study noted that SBRT is cost-effective and helps maintain a good quality of life for patients. Overall, SBRT has demonstrated positive results in treating prostate cancer, making it a strong option for patients needing radiation after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Chia-Lin Tseng, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9943785/

Preliminary Analysis of a Phase II Trial of Stereotactic Body ... Here, we present a preliminary analysis of a prospective phase II trial that aimed to evaluate the safety and efficacy of postprostatectomy SBRT for adjuvant ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624033686

Stereotactic Radiation Therapy for Localized Prostate Cancer SABR is an economical and effective treatment of localized prostate cancer 1 , 2 and is well tolerated with good toxicity and quality-of-life outcomes.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2723641

Long-term Outcomes of Stereotactic Body Radiotherapy for ... This cohort study of pooled individual patient data assesses long-term outcomes after stereotactic body radiotherapy for low-risk and ...

4. thegreenjournal.com thegreenjournal.com/issue/S0167-8140(25)X0003-7?pageStart=28

May 2025 Adoption of hypofractionation radiotherapy for localised prostate cancer and quality of life outcomes in an Australian population-based cohort

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7761604/

Ablative Radiotherapy in Prostate Cancer: Stereotactic Body ... Hoskin et al. reported favorable results in a cohort of patients who received 19–20 Gy in a single fraction compared to two fractions of 13 Gy ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405630823001349

Stereotactic body radiation therapy for prostate cancer after ... Prostate SBRT is feasible and safe in patients with a previous TURP or adenomectomy. Increased genitourinary toxicity is observed in patients with multiple ...

7. thegreenjournal.com thegreenjournal.com/issue/S0167-8140(25)X0003-7?pageStart=26

May 2025 Prostate cancer focal boost versus no boost in 20 fraction external beam radiotherapy: a prospective cohort on dosimetry, toxicity and quality of life

8. ctv.veeva.com ctv.veeva.com/study/daily-adaptive-post-prostatectomy-with-stereotactic-ablative-radiotherapy-in-patients-with-prostate

Daily Adaptive Post-Prostatectomy With Stereotactic Ablative ... This clinical trial evaluates the feasibility, safety, and tolerability of stereotactic ablative radiotherapy (SABR) using daily adaptive ...