Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderate hypofractionated boost to the prostate with pelvic RT (external beam radiotherapy).
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Acute Grade >2 Gastrointestinal Toxicity [Time frame: Baseline to 5-year follow-up]
Secondary outcome measures (8)
- Patient-reported quality-of-life assessed by EPIC-26 [Time frame: Baseline to 5-year Follow-up]
- Measure the severity of lower urinary tract symptoms during the study [Time frame: Baseline to 5-year Follow-up]
- Graded criteria based on CTCAE version 5.0 for acute genitourinary toxicity and late genitourinary and gastrointestinal toxicity [Time frame: Baseline to 5-year Follow-up]
- Measure of oncologic outcomes [Time frame: Baseline to 5-year Follow-up]
- Measure of oncologic outcomes [Time frame: Baseline to 5-year Follow-up]
- Measure of onocologic outcomes [Time frame: Baseline to 5-year Follow-up]
- Prostate cancer specific survival based on death from prostate cancer [Time frame: Baseline to 5-year Follow-up]
- Overall survival [Time frame: Baseline to 5-year Follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Princess Margaret Cancer Center — Toronto
Identifiers
NCT: NCT05313815 · 22-5218