SBRT for Post-Prostatectomy Prostate Cancer

(PLUTO Trial)

Overseen By Principle Investigator

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Radical prostatectomy is a common treatment for localized prostate cancer. More than 30% of men who undergo surgery will subsequently develop recurrence, particularly in patients with adverse features where the risk may be even higher. Recurrence typically manifests as a rise in serum-level of prostate-specific antigen (PSA), referred to as biochemical recurrence. Post-operative radiotherapy is a potentially curative option for many patients, as shown in multiple prior randomized studies. A standard course of post-operative radiation requires 6 to 6 and half weeks of treatment, 5 days a week; however, new high-precision radiation techniques with image guidance, termed stereotactic body radiotherapy (SBRT), can deliver an equivalent or higher dose of treatment in 5 visits. Our group, amongst others, have demonstrated in previous studies, that the new 5-treatment technique was safe, convenient and effective in patients with intact prostates. Currently, limited data exists on this approach after prostatectomy. This study will be one of the first to assess the side effect profile and efficacy of SBRT in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Eligibility Criteria

This trial is for men who've had surgery (prostatectomy) for localized prostate cancer but are at risk of recurrence. They should have a specific type of prostate cancer (adenocarcinoma), be in certain stages (T3 or T4, NX-0, M0), possibly with positive surgical margins or rising PSA levels post-surgery. Men with gross residual disease, node-positive status, distant metastases, hip replacements, or conditions that make pelvic radiotherapy risky can't join.

Inclusion Criteria

Completed written informed consent

My prostate cancer diagnosis was confirmed through a tissue examination.

Able and willing to complete self report questionnaires

Exclusion Criteria

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

I cannot undergo intensive pelvic radiotherapy due to certain health conditions.

You have a hip replacement.

Treatment Details

Interventions

• Linac-Based Ultrahypofractionated Radiotherapy

Trial Overview The study tests a new radiation therapy called SBRT after prostate surgery. Unlike traditional post-op radiotherapy which takes over 6 weeks, SBRT delivers the same or higher dose in just 5 sessions using high-precision techniques. The goal is to see if this quicker method is as safe and effective for treating patients without intact prostates.

Participant Groups

Group I: SBRT post operative Experimental Treatment 1 Intervention

Stereotactic Body Radiotherapy (SBRT) 30 Gy in 5 fractions, once weekly to prostate bed * / - 25 Gy in 5 fractions, once weekly simultaneously to pelvic lymph nodes * / - 6-24 months of androgen deprivation therapy (ADT)

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+