Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer
NCT ID: NCT04239599
Last Updated: 2022-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
178 participants
INTERVENTIONAL
2011-03-31
2023-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypofractionation
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) + 18-36 months of Eligard Hormone injection.
Hypofractionated IMRT Radiation treatment
Standard Fractination
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 + 18-36 months of Eligard Hormone injection.
Hypofractionated IMRT Radiation treatment
Interventions
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Hypofractionated IMRT Radiation treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Patrick Cheung, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Other Identifiers
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RCT- PHART2
Identifier Type: -
Identifier Source: org_study_id
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