Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
NCT ID: NCT03526510
Last Updated: 2022-03-08
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
2011-06-30
2024-12-31
Brief Summary
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Detailed Description
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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.
* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Conventionally Fractionated versus Hypofractionated Boost
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).
Conventionally Fractionated versus Hypofractionated Boost
Interventions
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Conventionally Fractionated versus Hypofractionated Boost
Eligibility Criteria
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Inclusion Criteria
* 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 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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Dr. Patrick Cheung
OTHER
Responsible Party
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Dr. Patrick Cheung
Radiation Oncologist
Principal Investigators
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Patrick Cheung, MD
Role: STUDY_CHAIR
Toronto Sunnybrook Regional Cancer Centre
Locations
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Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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pHART2 RCT
Identifier Type: -
Identifier Source: org_study_id
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