Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04848909
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : September 21, 2021
Sponsor:
Collaborators:
Royal Victoria Regional Health Centre
Princess Margaret Hospital, Canada
Credit Valley Hospital
Information provided by (Responsible Party):
Chia-Lin (Eric) Tseng, Sunnybrook Health Sciences Centre

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: stereotactic body radiotherapy (SBRT) Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: men diagnosed with prostate cancer post-prostatectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study
Actual Study Start Date : June 3, 2021
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Late Adverse Events/toxicities experienced by Participants [ Time Frame: 6.5 years ]
    Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0

  2. Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire [ Time Frame: 6.5 years ]
    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.

  3. Biochemical disease-free survival [ Time Frame: 6.5 years ]
    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

  4. Health Utilities using The Patient-Oriented Prostate Utility Scale [ Time Frame: 6.5years ]
    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.

  5. Health Utilities using EuroQol- 5 Dimension Questionnaire [ Time Frame: 6.5years ]

    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:

    1. Mobility
    2. Self-care
    3. Usual Activities
    4. Pain/discomfort
    5. Anxiety/depression


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04848909


Contacts
Layout table for location contacts
Contact: Tiffany Tassopoulos 416-480-6100 ext 88144 tiffany.tassopoulos@sunnybrook.ca
Contact: Kerri Durrant 416-480-6100 ext 89518 keri.durrant@sunnybrook.ca

Locations
Layout table for location information
Canada, Onatrio
Sunnybrook Cancer center Recruiting
Toronto, Onatrio, Canada, M4N 3M5
Contact: Kerri Durrant    416-480-6100 ext 89518    keri.durrant@sunnybrook.ca   
Principal Investigator: Chia-Lin Tseng, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Royal Victoria Regional Health Centre
Princess Margaret Hospital, Canada
Credit Valley Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dr. Chia-Lin Tseng, MD, FRCPC Sunnybrook Health Sciences Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Chia-Lin (Eric) Tseng, Principal Investigator, Assistant Professor, Dept of Radiation Oncology Sunnybrook Odette Cancer Centre, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04848909    
Other Study ID Numbers: 3596
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases