Back to resultsHypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Conventionally Fractionated versus Hypofractionated Boost
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring High Risk Prostate Cancer, Radiotherapy
Eligibility Criteria
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
Sites / Locations
- Sunnybrook Odette Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Fractionation
Hypofractionation
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Acute Toxicity
Proportion of patients experiencing grade >=2 acute toxicity
Secondary Outcome Measures
Late Toxicity
Proportion of patients experiencing grade >= 2 late toxicity
Biochemical Control (Phoenix Definition)
Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)
Overall Survival
Actuarial measure of patients being alive
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03526510
Brief Title
Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
Official Title
Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2011 (Actual)
Primary Completion Date
November 2021 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Patrick Cheung
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
High Risk Prostate Cancer, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Fractionation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hypofractionation
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Conventionally Fractionated versus Hypofractionated Boost
Primary Outcome Measure Information:
Title
Acute Toxicity
Description
Proportion of patients experiencing grade >=2 acute toxicity
Time Frame
within 3 months after starting radiotherapy
Secondary Outcome Measure Information:
Title
Late Toxicity
Description
Proportion of patients experiencing grade >= 2 late toxicity
Time Frame
beyond 3 months of starting radiotherapy
Title
Biochemical Control (Phoenix Definition)
Description
Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL)
Time Frame
at 5 years
Title
Overall Survival
Description
Actuarial measure of patients being alive
Time Frame
at 5 years
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Cheung, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer
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