Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

Not Applicable

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT01423474
• Lead Sponsor: CancerCare Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-26
• Study Start: 2012-01
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bowel related quality-of-life	3 months

Secondary Outcome Measures

Name	Time	Method
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	Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
PSA relapse rate	3 and 5 years
Gastrointestinal toxicity	During radiotherapy, at 3 and 6 months, then every 6 months after	Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
Salvage androgen deprivation therapy rate	3 and 5 years

Trial Locations

Locations (3)

BC Cancer Agency - Abbotsford Centre; 🇨🇦 Abbotsford, British Columbia, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada