Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, radiotherapy, hypofraction, radiosensitivity, image-guidance
Eligibility Criteria
Inclusion Criteria: Stage T1 and T2 prostate cancer Prostate specific antigen (PSA)>=20 and Gleason score<=6 PSA<=15 and Gleason score 7 Signed informed consent Exclusion Criteria: No hip prosthesis, pins or screws No previous pelvic radiotherapy No inflammatory bowel disease
Sites / Locations
- Tom Baker Cancer Centre
Outcomes
Primary Outcome Measures
rectal morbidity
Secondary Outcome Measures
Full Information
NCT ID
NCT00126165
First Posted
August 2, 2005
Last Updated
January 18, 2012
Sponsor
Alberta Health services
Collaborators
Calgary Health Region
1. Study Identification
Unique Protocol Identification Number
NCT00126165
Brief Title
Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer
Official Title
A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alberta Health services
Collaborators
Calgary Health Region
4. Oversight
5. Study Description
Brief Summary
This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.
Detailed Description
This study is aimed at providing further clinical evidence to support or refute the current understanding of biological sensitivity of prostate cancer to fractionated radiotherapy. Determining the morbidity and cancer control provided by a 4-week course of treatment will greatly influence future radiotherapy services for patients with localized prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, radiotherapy, hypofraction, radiosensitivity, image-guidance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
radiotherapy
Primary Outcome Measure Information:
Title
rectal morbidity
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage T1 and T2 prostate cancer
Prostate specific antigen (PSA)>=20 and Gleason score<=6
PSA<=15 and Gleason score 7
Signed informed consent
Exclusion Criteria:
No hip prosthesis, pins or screws
No previous pelvic radiotherapy
No inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackson Wu
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22280805
Citation
Wu JS, Brasher PM, El-Gayed A, Pervez N, Tai PT, Robinson J, Skarsgard D, Joseph K, Sia MA, Pearcey RG. Phase II study of hypofractionated image-guided radiotherapy for localized prostate cancer: outcomes of 55 Gy in 16 fractions at 3.4 Gy per fraction. Radiother Oncol. 2012 May;103(2):210-6. doi: 10.1016/j.radonc.2011.12.020. Epub 2012 Jan 24.
Results Reference
derived
Learn more about this trial
Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer
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