- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146340
Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer (PHART6)
October 2, 2019 updated by: Andrew Loblaw, Sunnybrook Health Sciences Centre
Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men >18 years
- Histologically confirmed prostate adenocarcinoma
- Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL
Exclusion Criteria:
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Presence of a hip prosthesis
- Pelvic girth >40cm - Large prostate (>90cm3) on imaging
- Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SBRT
SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT
|
40 Gy / 5 fractions / 29 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of grade 3+ rectal toxicity
Time Frame: Acute period (<3 months)
|
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
Acute period (<3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of grade 3+ urinary toxicity
Time Frame: Acute (<3 months) and Late (>6 months)
|
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
Acute (<3 months) and Late (>6 months)
|
Quality of Life
Time Frame: 5 years
|
Expanded Prostate Cancer Index Composite (EPIC)
|
5 years
|
Biochemical (ie. prostate specific antigen) disease free survival
Time Frame: 5 year
|
5 year
|
|
Incidence of grade 3+ rectal toxicity
Time Frame: Late (>6 months)
|
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
Late (>6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Harvey Quon, MD, Sunnybrook Health Sciences Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
June 14, 2010
First Submitted That Met QC Criteria
June 16, 2010
First Posted (Estimate)
June 17, 2010
Study Record Updates
Last Update Posted (Actual)
October 4, 2019
Last Update Submitted That Met QC Criteria
October 2, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 042-2010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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