Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy (PLUTO-MPC)

Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study

This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: stereotactic body radiotherapy (SBRT)

Detailed Description

Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiffany Tassopoulos; Phone Number: 88144 416-480-6100; Email: tiffany.tassopoulos@sunnybrook.ca
• Study Contact Backup: Name: Kerri Durrant; Phone Number: 89518 416-480-6100; Email: keri.durrant@sunnybrook.ca

Study Locations

• Canada
  • Onatrio
    • Toronto, Onatrio, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Cancer center
      • Contact: Kerri Durrant; Phone Number: 89518 416-480-6100; Email: keri.durrant@sunnybrook.ca
      • Principal Investigator: Chia-Lin Tseng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
• Completed written informed consent
• Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
• A detectable PSA ≤ 2.0 ng/ml
• Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA

Exclusion Criteria:

• Gross residual disease (per conventional imaging, i.e. CT and/or MRI)
• Histological or radiological node +ve (N1) or distant metastases (M1)
• Prior pelvic radiotherapy
• Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Men with prostate cancer post-prostatectomy; Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.

Radiation: stereotactic body radiotherapy (SBRT); Stereotactic body or external-beam radiation therapy (SBRT) is a method of delivery of radiation in precision manner to the prostate bed in this study. The SBRT dose prescription will be 3000 cGy in 5 fractions to the prostate bed and 2500 cGy in 5 fractions to the pelvic nodes if elective nodal irradiation (ENI) is used, delivered every other business day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Adverse Events/toxicities experience by Participants	Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0	6.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Adverse Events/toxicities experienced by Participants	Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0	6.5 years
Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire	Acute and late GU and GI quality of life (QoL) using the Expanded Prostate Cancer Index Composite questionnaire which evaluates participant's function and bother after prostate cancer treatment. Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.	6.5 years
Biochemical disease-free survival	Biochemical disease-free survival (bDFS), defined as survival until first evidence of either biochemical progression (PSA of 0.4 ng/mL or greater) following postoperative radiotherapy, PSA of more than 2.0 ng/mL at any time after postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol hormone therapy, or death from prostate cancer	6.5 years
Health Utilities using The Patient-Oriented Prostate Utility Scale	Health utilities using The Patient-Oriented Prostate Utility Scale to measure health-related quality of life, whether it improves, deteriorates or stay the same. There are 10 questions, each questions has 5 possible answers, with 1 being the better outcome and 5 being the worst outcome.	6.5years
Health Utilities using EuroQol- 5 Dimension Questionnaire	Health utilities using the EuroQol- 5 Dimension Questionnaire determines 5 variables, each with 5 possible options, with the first being the best outcome and the last being the worst outcome. The 5 variables include: Mobility; Self-care; Usual Activities; Pain/discomfort; Anxiety/depression	6.5years

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Princess Margaret Hospital, Canada; Royal Victoria Regional Health Centre; Credit Valley Hospital
• Investigators: Principal Investigator: Dr. Chia-Lin Tseng, MD, FRCPC, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 3596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No