Back to resultsModerate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer (MOB-RT)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, high risk prostate cancer, high-risk prostate cancer, node positive prostate cancer, nod-positive prostate cancer, hypofractionation
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years.
- Able to provide informed consent.
- Histologic diagnosis of prostate adenocarcinoma.
- ECOG performance status 0-1.
- High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease.
- Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))
Exclusion Criteria:
- Prior pelvic radiotherapy.
- Contraindications to radiotherapy
Sites / Locations
- Princess Margaret Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy
Arm Description
External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes
Outcomes
Primary Outcome Measures
Acute Grade >2 Gastrointestinal Toxicity
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Secondary Outcome Measures
Patient-reported quality-of-life assessed by EPIC-26
Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)
Measure the severity of lower urinary tract symptoms during the study
Patient-Reported symptoms will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: International Prostate Symptom Score (IPSS)
Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity
Acute (less than or equal to 90 days) and long-term (greater than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measure of oncologic outcomes
Time to development of castrate-resistant prostate cancer (biochemmical or ardiographic progression while having castrate levels of testosterone)
Measure of oncologic outcomes
Biochemical control rate will be assessed at baseline and at each follow-up visit (3 weeks after treatment then every 6 months until 5 years or more frequently if clinically necessary) by the blood level of prostate-specific antigen (PSA) levels
Measure of onocologic outcomes
Radiographic control rate will be assess at baseline and weekly during the radiotherapy intervention using cone beam CT or bone scan.
Prostate cancer specific survival based on death from prostate cancer
Safety will be evaluated by recording prostate cancer mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary)
Overall survival
Safety will be evaluated by recording overall mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary).
Full Information
NCT ID
NCT05313815
First Posted
March 15, 2022
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05313815
Brief Title
Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
Acronym
MOB-RT
Official Title
Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, high risk prostate cancer, high-risk prostate cancer, node positive prostate cancer, nod-positive prostate cancer, hypofractionation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy
Arm Type
Experimental
Arm Description
External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes
Intervention Type
Radiation
Intervention Name(s)
Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)
Intervention Description
External beam radiotherapy- 60 Gy in 20 fractions to the prostate, 48 Gy in 20 fractions to the pelvis, 68 Gy in 20 fraction optional boost to prostatic dominant intraprostatic lesion, 55 Gy in 20 fraction optional boost to involved pelvic lymph nodes
Primary Outcome Measure Information:
Title
Acute Grade >2 Gastrointestinal Toxicity
Description
Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
Baseline to 5-year follow-up
Secondary Outcome Measure Information:
Title
Patient-reported quality-of-life assessed by EPIC-26
Description
Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)
Time Frame
Baseline to 5-year Follow-up
Title
Measure the severity of lower urinary tract symptoms during the study
Description
Patient-Reported symptoms will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: International Prostate Symptom Score (IPSS)
Time Frame
Baseline to 5-year Follow-up
Title
Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity
Description
Acute (less than or equal to 90 days) and long-term (greater than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
Baseline to 5-year Follow-up
Title
Measure of oncologic outcomes
Description
Time to development of castrate-resistant prostate cancer (biochemmical or ardiographic progression while having castrate levels of testosterone)
Time Frame
Baseline to 5-year Follow-up
Title
Measure of oncologic outcomes
Description
Biochemical control rate will be assessed at baseline and at each follow-up visit (3 weeks after treatment then every 6 months until 5 years or more frequently if clinically necessary) by the blood level of prostate-specific antigen (PSA) levels
Time Frame
Baseline to 5-year Follow-up
Title
Measure of onocologic outcomes
Description
Radiographic control rate will be assess at baseline and weekly during the radiotherapy intervention using cone beam CT or bone scan.
Time Frame
Baseline to 5-year Follow-up
Title
Prostate cancer specific survival based on death from prostate cancer
Description
Safety will be evaluated by recording prostate cancer mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary)
Time Frame
Baseline to 5-year Follow-up
Title
Overall survival
Description
Safety will be evaluated by recording overall mortality at follow-up visits (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary).
Time Frame
Baseline to 5-year Follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years.
Able to provide informed consent.
Histologic diagnosis of prostate adenocarcinoma.
ECOG performance status 0-1.
High-risk localized disease by NCCN criteria (>cT3, Grade group >4, or PSA >20 ng/mL) or clinical N1 disease.
Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET))
Exclusion Criteria:
Prior pelvic radiotherapy.
Contraindications to radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Glicksman, MD
Phone
416-946-4486
Email
rachel.glicksman@rmp.uhn.ca
Facility Information:
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Glicksman, MD
Phone
416-946-4483
Email
rachel.glicksman@rmp.uhn.ca
12. IPD Sharing Statement
Learn more about this trial
Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
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