Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer

CancerCare Manitoba3 sites in 1 country152 target enrollmentJanuary 2012

ConditionsProstatic Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostatic Neoplasms
Sponsor: CancerCare Manitoba
Enrollment: 152
Locations: 3
Primary Endpoint: Bowel related quality-of-life
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. Patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. Both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

August 2019

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

CancerCare Manitoba

Responsible Party

Principal Investigator

Dr. Aldrich Ong

Radiation Oncologist

CancerCare Manitoba

Eligibility Criteria

Inclusion Criteria

•Low or intermediate risk prostate cancer patients as defined by:
•Clinical stage T1-2b, Gleason Score \<=7, and PSA \<=20 ng/mL
•Age \>= 18 years

Exclusion Criteria

•Androgen deprivation therapy (LHRH-agonists or antiandrogens) \>6 months
•Prior pelvic radiotherapy
•Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
•Diagnosis of bleeding diathesis
•Large prostate (\>90cm3) on imaging
•Immunosuppressive medications
•Inflammatory bowel disease

Outcomes

Primary Outcomes

Bowel related quality-of-life

Time Frame: 3 months

Secondary Outcomes

Patient Overall Quality of life(During radiotherapy, at 3 and 6 months, then every 6 months after)
Genitourinary toxicity(During radiotherapy, at 3 and 6 months, then every 6 months after)
PSA relapse rate(3 and 5 years)
Gastrointestinal toxicity(During radiotherapy, at 3 and 6 months, then every 6 months after)
Salvage androgen deprivation therapy rate(3 and 5 years)