Short-course Hypofractionated Radiotherapy for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase I/II Study of Escalated-dose Short-course Hypofractionated Radiotherapy (55 Gy/16 Fractions/4 Weeks) for Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126165
• Other study ID #: 17885
• Secondary ID: 17885
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 2, 2005
• Last updated: January 18, 2012
• Start date: September 2004
• Est. completion date: August 2011

Study information

• Verified date: January 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• radiotherapy

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Health Services	Calgary Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rectal morbidity