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

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)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering radiation treatment after prostate surgery to assess its safety and effectiveness. It targets prostate cancer that recurs or is likely to recur after surgery, often indicated by rising PSA levels (a protein produced by the prostate). The study employs a precise form of radiation therapy called SBRT (Stereotactic Body Radiation Therapy), which aims to complete treatment in just 5 visits instead of the usual 6 weeks. It is suitable for men who have undergone prostate surgery, show signs of cancer recurrence, and do not have other major health issues such as hip replacements or previous pelvic radiation. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance future prostate cancer treatments.

Will I have to stop taking my current medications?

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 this technique is safe for post-prostatectomy prostate cancer patients?

Research has shown that a precise type of radiation therapy, called stereotactic body radiotherapy (SBRT), is safe and generally well-tolerated after prostate surgery. Studies have found no serious short-term side effects. Approximately 15% of patients experienced mild long-term side effects, which is considered low. Patients reported a good quality of life during and after treatment. This evidence suggests that SBRT is a safe option for individuals who have undergone prostate surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Linac-Based Ultrahypofractionated Radiotherapy for post-prostatectomy prostate cancer because it offers a unique approach compared to traditional treatments like conventional radiotherapy and surgery. This treatment delivers high doses of radiation in just five sessions, once a week, rather than over several weeks, which could potentially shorten treatment time and improve patient convenience. Additionally, it targets the prostate bed and can simultaneously treat pelvic lymph nodes, possibly enhancing effectiveness. The combination with androgen deprivation therapy (ADT) for up to 24 months might also improve outcomes by reducing hormone levels that fuel cancer growth.

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

Studies have shown that stereotactic body radiotherapy (SBRT), a precise radiation treatment, can be safe and effective for prostate cancer patients. In this trial, participants will receive SBRT post-operatively, delivering 30 Gy in 5 fractions once weekly to the prostate bed, with optional treatment to the pelvic lymph nodes and androgen deprivation therapy (ADT) for 6-24 months. Research indicates that using SBRT on the prostate area after surgery effectively controls cancer markers, with no severe early side effects and manageable later ones. This method uses higher doses of radiation in fewer sessions, which has been linked to good control of cancer markers, effectively keeping them in check. Patients have reported that SBRT does not significantly affect their quality of life, making it a promising option for those who have had their prostate removed. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

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) 30 Gy in 5 fractions, once weekly to prostate bed and 25 Gy in 5 fractions, once weekly to pelvic lymph nodes

5 weeks

5 visits (in-person)

Androgen Deprivation Therapy (ADT)

Participants undergo 6-24 months of androgen deprivation therapy

6-24 months

Follow-up

Participants are monitored for acute and late genitourinary (GU) and gastrointestinal (GI) toxicities, as well as biochemical disease-free survival

Up to 3 years

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. urotoday.com urotoday.com/conference-highlights/astro-2024/astro-2024-prostate-cancer/155245-astro-2024-post-prostatectomy-linac-based-ultrahypofractionated-radiotherapy-for-patients-with-localized-prostate-cancer-toxicity-and-quality-of-life-results-from-a-prospective-trial.html

ASTRO 2024: Post-Prostatectomy Linac-Based ... Data from multiple studies suggest that prostate cancer may be more sensitive to higher doses per fraction of RT, aligning with the Stereotactic Body ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143922004860

Treatment outcomes of postoperative ultra ... Postoperative ultra-fractionated SBRT showed no severe acute toxicity and late toxicity rates of about 15%, in addition to excellent biochemical control rates.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10726256/

Toxicity profile and Patient-Reported outcomes following ... Our findings show that post-prostatectomy SBRT did not result in increased toxicity nor a significant decline in QoL measures, thus showing that it can be ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04848909

Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients. Official Title. Post- ...

5. trial.medpath.com trial.medpath.com/clinical-trial/5d3217095c710208/post-prostatectomy-linac-based-radiotherapy-prostate-cancer

Post-Prostatectomy Linac-Based Ultrahypofractionated ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9776836/

Acute Toxicity and Quality of Life in a Post-Prostatectomy ... Conclusions: Our preliminary findings show that SBRT can be safely extended to the postoperative setting, without an increase in short-term ...

7. ctro.science ctro.science/article/S2405-6308(23)00129-5/fulltext

Toxicity profile and Patient-Reported outcomes following ... In this multicentric prospective study, post-prostatectomy SBRT did not result in increased toxicity nor in a significant decline in QoL ...