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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
stereotactic body radiotherapy (SBRT)
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Sunnybrook Cancer centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Men with prostate cancer post-prostatectomy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Late Adverse Events/toxicities experienced by Participants
Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0
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.
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
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.
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

Full Information

First Posted
April 12, 2021
Last Updated
October 25, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Royal Victoria Regional Health Centre, Princess Margaret Hospital, Canada, Credit Valley Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04848909
Brief Title
Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy
Acronym
PLUTO-MPC
Official Title
Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Royal Victoria Regional Health Centre, Princess Margaret Hospital, Canada, Credit Valley Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
men diagnosed with prostate cancer post-prostatectomy
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Men with prostate cancer post-prostatectomy
Arm Type
Experimental
Arm Description
Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiotherapy (SBRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early Adverse Events/toxicities experience by Participants
Description
Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
6.5 years
Secondary Outcome Measure Information:
Title
Late Adverse Events/toxicities experienced by Participants
Description
Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0
Time Frame
6.5 years
Title
Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire
Description
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.
Time Frame
6.5 years
Title
Biochemical disease-free survival
Description
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
Time Frame
6.5 years
Title
Health Utilities using The Patient-Oriented Prostate Utility Scale
Description
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.
Time Frame
6.5years
Title
Health Utilities using EuroQol- 5 Dimension Questionnaire
Description
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
Time Frame
6.5years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Tassopoulos
Phone
416-480-6100
Ext
88144
Email
tiffany.tassopoulos@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kerri Durrant
Phone
416-480-6100
Ext
89518
Email
keri.durrant@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Chia-Lin Tseng, MD, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Cancer center
City
Toronto
State/Province
Onatrio
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerri Durrant
Phone
416-480-6100
Ext
89518
Email
keri.durrant@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Chia-Lin Tseng, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy

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