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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT05313815

Collaborator

(none)

100

Enrollment

Location

Arm

95.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 18, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy 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	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

Arm

Intervention/Treatment

Experimental: Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy

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

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

Outcome Measures

Primary Outcome Measures

Acute Grade >2 Gastrointestinal Toxicity [Baseline to 5-year follow-up]
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 [Baseline to 5-year Follow-up]
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 [Baseline to 5-year Follow-up]
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 [Baseline to 5-year Follow-up]
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 [Baseline to 5-year Follow-up]
Time to development of castrate-resistant prostate cancer (biochemmical or ardiographic progression while having castrate levels of testosterone)
Measure of oncologic outcomes [Baseline to 5-year Follow-up]
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 [Baseline to 5-year Follow-up]
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 [Baseline to 5-year Follow-up]
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 [Baseline to 5-year Follow-up]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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))