Prostate Cancer
Conditions
Brief summary
Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly. Standard Fractionation: 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 over 39 fractions.
Detailed description
Half the participants will receive 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). The other half of the participants will receive 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.
Interventions
RADIATIONHypofractionated IMRT Radiation treatment
Sponsors
Sanofi
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is a randomized Radiation 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. * Clinical stage 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 |
|---|---|---|
| Disease free survival | 5 years | The primary outcome for this study is PSA biochemical disease free survival at 5 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late GI and GU toxicities | 6 month post completion of treatment to end of 5 year follow up | Number of participants with treatment-related adverse events as assessed by CTCAE v3.0, change from 6 months post treatment to end of 5 year follow-up. |
| Quality of life outcome: Expanded Prostate Index Composite (EPIC) | Baseline (start of treatment) to end of 5 year follow-up | Measuring quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire consists of 50 questions. Each question is scored from 1-5, 5 being the better outcome and 1 being the worst outcome in most of the questions |
| Overall survival | Baseline to end of 5 year follow-up | Overall survival comparing two treatment arms |
| Cancer specific survival | Baseline to end of 5 year follow-up | Cancer specific survival comparing two treatment arms |
Outcome results
None listed