Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
Study Details
Study Description
Brief Summary
Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Patients enrolled onto this study will be randomized to one of the following treatment arms:
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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.
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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
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: 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. |
Radiation: Conventionally Fractionated versus Hypofractionated Boost
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Experimental: 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). |
Radiation: Conventionally Fractionated versus Hypofractionated Boost
|
Outcome Measures
Primary Outcome Measures
- Acute Toxicity [within 3 months after starting radiotherapy]
Proportion of patients experiencing grade >=2 acute toxicity
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent obtained.
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Histologically confirmed diagnosis of adenocarcinoma of the prostate.
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T1-2 N0 M0, Gleason Score <= 7, PSA 20 - 100
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T1-2 N0 M0, Gleason Score 8 - 10, PSA <= 100
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T3 N0 M0, any Gleason Score, PSA <= 100
Exclusion Criteria:
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Patients with unilateral or bilateral hip replacement.
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Patients with active collagen vascular disease.
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Patients with active inflammatory bowel disease.
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Patients with previous radiotherapy to the pelvis.
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Patients with ataxia telangiectasia.
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Patients with nodal or distant metastases
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sunnybrook Odette Cancer Centre | Toronto | Ontario | Canada | M4N 3M5 |
Sponsors and Collaborators
- Dr. Patrick Cheung
Investigators
- Study Chair: Patrick Cheung, MD, Toronto Sunnybrook Regional Cancer Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- pHART2 RCT