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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Hypofracitonated Boost to the Prostate with Pelvic Radiation Therapy<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, high risk prostate cancer, high-risk prostate cancer, node positive prostate cancer, nod-positive prostate cancer, hypofractionation