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Clinical Trials/NCT01146340
NCT01146340
Completed
Phase 1

Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

Sunnybrook Health Sciences Centre1 site in 1 country30 target enrollmentMay 2010
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ConditionsProstate Cancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
30
Locations
1
Primary Endpoint
Incidence of grade 3+ rectal toxicity
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
April 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrew Loblaw

Radiation Oncologist

Sunnybrook Health Sciences Centre

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Incidence of grade 3+ rectal toxicity

Time Frame: Acute period (<3 months)

Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Secondary Outcomes

  • Quality of Life(5 years)
  • Incidence of grade 3+ rectal toxicity(Late (>6 months))
  • Incidence of grade 3+ urinary toxicity(Acute (<3 months) and Late (>6 months))
  • Biochemical (ie. prostate specific antigen) disease free survival(5 year)

Study Sites (1)

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