Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer

Prostate Cancer Clinical Trial

— MOB-RT  

Official title:

Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313815
• Other study ID #: 22-5218
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: July 2030

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Rachel Glicksman, MD
• Phone: 416-946-4486
• Email: rachel.glicksman[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)
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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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