Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 178
- Locations
- 1
- Primary Endpoint
- Acute Toxicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
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.
Intervention: Conventionally Fractionated versus Hypofractionated Boost (Radiation)
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).
Intervention: Conventionally Fractionated versus Hypofractionated Boost (Radiation)
Outcomes
Primary Outcomes
Acute Toxicity
Time Frame: within 3 months after starting radiotherapy
Proportion of patients experiencing grade \>=2 acute toxicity
Secondary Outcomes
- Biochemical Control (Phoenix Definition)(at 5 years)
- Overall Survival(at 5 years)
- Late Toxicity(beyond 3 months of starting radiotherapy)
Investigators
Dr. Patrick Cheung
Radiation Oncologist
Sunnybrook Health Sciences Centre