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Radiation Therapy

SBRT for Post-Prostatectomy Prostate Cancer (PLUTO Trial)

N/A

Waitlist Available

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

Must not have

Histological or radiological node +ve (N1) or distant metastases (M1)

Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 3 years

Awards & highlights

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I still have visible cancer after surgery.

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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute genitourinary (GU) and gastrointestinal (GI) toxicities

Secondary study objectives

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

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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

0 / 6Eligibility criteria met