Back to resultsTrial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer (RCT-PHART2)
Primary Purpose
Prostate Cancer
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypofractionated IMRT Radiation treatment
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Written informed consent obtained.
- 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 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hypofractionation
Standard Fractination
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Disease free survival
The primary outcome for this study is PSA biochemical disease free survival at 5 years.
Secondary Outcome Measures
Late GI and GU toxicities
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0, change from 6 months post treatment to end of 5 year follow-up.
Quality of life outcome: Expanded Prostate Index Composite (EPIC)
Measuring quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire consists of 50 questions. Each question is scored from 1-5, 5 being the better outcome and 1 being the worst outcome in most of the questions
Overall survival
Overall survival comparing two treatment arms
Cancer specific survival
Cancer specific survival comparing two treatment arms
Full Information
NCT ID
NCT04239599
First Posted
October 29, 2019
Last Updated
September 27, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT04239599
Brief Title
Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer
Acronym
RCT-PHART2
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
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2011 (undefined)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.
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.
Detailed Description
Half the participants will receive 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
This is a randomized Radiation trial
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Fractination
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 + 18-36 months of Eligard Hormone injection.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated IMRT Radiation treatment
Other Intervention Name(s)
Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months
Primary Outcome Measure Information:
Title
Disease free survival
Description
The primary outcome for this study is PSA biochemical disease free survival at 5 years.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Late GI and GU toxicities
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0, change from 6 months post treatment to end of 5 year follow-up.
Time Frame
6 month post completion of treatment to end of 5 year follow up
Title
Quality of life outcome: Expanded Prostate Index Composite (EPIC)
Description
Measuring quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire consists of 50 questions. Each question is scored from 1-5, 5 being the better outcome and 1 being the worst outcome in most of the questions
Time Frame
Baseline (start of treatment) to end of 5 year follow-up
Title
Overall survival
Description
Overall survival comparing two treatment arms
Time Frame
Baseline to end of 5 year follow-up
Title
Cancer specific survival
Description
Cancer specific survival comparing two treatment arms
Time Frame
Baseline to end of 5 year follow-up
10. Eligibility
Sex
Male
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.
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 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
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share Individual Participant data. Results from the trial will be available through publications.
Learn more about this trial
Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer
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