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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Princess Margaret Cancer Center
Toronto, Ontario, Canada
RECRUITINGAcute 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.
Time frame: Baseline to 5-year follow-up
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)
Time frame: 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)
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
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.
Time frame: 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)
Time frame: Baseline to 5-year Follow-up
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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
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: Baseline to 5-year Follow-up