Prostate Cancer Clinical Trial
— MOB-RTOfficial title:
Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
NCT number | NCT05313815 |
Other study ID # | 22-5218 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2022 |
Est. completion date | July 2030 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2030 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Center | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline to 5-year follow-up | |
Secondary | 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) | Baseline to 5-year Follow-up | |
Secondary | 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) | Baseline to 5-year Follow-up | |
Secondary | 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. | Baseline to 5-year Follow-up | |
Secondary | Measure of oncologic outcomes | Time to development of castrate-resistant prostate cancer (biochemmical or ardiographic progression while having castrate levels of testosterone) | Baseline to 5-year Follow-up | |
Secondary | 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 | Baseline to 5-year Follow-up | |
Secondary | 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. | Baseline to 5-year Follow-up | |
Secondary | 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) | Baseline to 5-year Follow-up | |
Secondary | 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). | Baseline to 5-year Follow-up |
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