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Radiation Therapy

SBRT for Post-Prostatectomy Prostate Cancer (PLUTO Trial)

N/A
Recruiting
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of adenocarcinoma of the prostate
Pathologic stage T3 or T4 (without any gross residual disease), NX-0, M0, and/or +ve surgical margins, and/or a rising PSA post-radical prostatectomy on at least 2 consecutive measurements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 3 years
Awards & highlights

PLUTO Trial Summary

This trial is testing a new, high-precision radiation technique called stereotactic body radiotherapy (SBRT) to see if it is safe and effective in treating localized prostate cancer after a radical prostatectomy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not specified here, typical side effects of SBRT may include urinary issues like frequency and discomfort; bowel changes such as diarrhea; fatigue; skin irritation around the treatment area; and erectile dysfunction.

PLUTO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer diagnosis was confirmed through a tissue examination.
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My prostate cancer is advanced but hasn't spread beyond the prostate.

PLUTO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute genitourinary (GU) and gastrointestinal (GI) toxicities
Secondary outcome measures
Biochemical disease-free survival (bDFS)
Incidence of late GU and GI toxicities (≥6 months)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

PLUTO Trial Design

1Treatment groups
Experimental Treatment
Group I: SBRT post operativeExperimental Treatment1 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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SBRT
2014
Completed Phase 2
~1060

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
654 Previous Clinical Trials
1,543,267 Total Patients Enrolled

Media Library

Linac-Based Ultrahypofractionated Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04067570 — N/A
Radical Prostatectomy Research Study Groups: SBRT post operative
Radical Prostatectomy Clinical Trial 2023: Linac-Based Ultrahypofractionated Radiotherapy Highlights & Side Effects. Trial Name: NCT04067570 — N/A
Linac-Based Ultrahypofractionated Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04067570 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently enrolled in this experiment?

"Affirmative. The information available on clinicaltrials.gov indicates that this research is presently enrolling patients, with the initial post dating back to 11th of July 2019 and most recent update occuring on 17th of March 2020. A total of 30 participants are required for one centre in order to satisfy recruitment requirements."

Answered by AI

Is this trial currently available to participants?

"Clinicaltrials.gov reveals that this clinical trial is actively searching for patients, first posted on November 7th 2019 and most recently edited March 17th 2020."

Answered by AI
~3 spots leftby Oct 2024