Prostate Cancer
Conditions
Keywords
prostate cancer, high risk prostate cancer, high-risk prostate cancer, node positive prostate cancer, nod-positive prostate cancer, hypofractionation
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.
Interventions
RADIATIONModerate 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
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
Countries
Canada
Contacts
CONTACTRachel Glicksman, MD
Outcome results
None listed