Prostate Cancer
Conditions
Keywords
High Risk Prostate Cancer, Radiotherapy
Brief summary
Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
Detailed description
Patients enrolled onto this study will be randomized to one of the following treatment arms: * Standard fractionation: Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy. * Hypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost). In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.
Interventions
RADIATIONConventionally Fractionated versus Hypofractionated Boost
Sponsors
Dr. Patrick Cheung
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent obtained. * Histologically confirmed diagnosis of adenocarcinoma of the prostate. * T1-2 N0 M0, Gleason Score \<= 7, PSA 20 - 100 * T1-2 N0 M0, Gleason Score 8 - 10, PSA \<= 100 * T3 N0 M0, any Gleason Score, PSA \<= 100
Exclusion criteria
* Patients with unilateral or bilateral hip replacement. * Patients with active collagen vascular disease. * Patients with active inflammatory bowel disease. * Patients with previous radiotherapy to the pelvis. * Patients with ataxia telangiectasia. * Patients with nodal or distant metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Toxicity | within 3 months after starting radiotherapy | Proportion of patients experiencing grade \>=2 acute toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Toxicity | beyond 3 months of starting radiotherapy | Proportion of patients experiencing grade \>= 2 late toxicity |
| Biochemical Control (Phoenix Definition) | at 5 years | Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL) |
| Overall Survival | at 5 years | Actuarial measure of patients being alive |
Countries
Canada
Outcome results
None listed