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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
Alberta Health services
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, radiotherapy, hypofraction, radiosensitivity, image-guidance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
August 2, 2005
Last Updated
January 18, 2012
Sponsor
Alberta Health services
Collaborators
Calgary Health Region
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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

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Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer

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