Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time (PATRIOT)

This study is currently recruiting participants.

Verified February 2012 by CancerCare Manitoba

Sponsor:

Collaborator:

Sunnybrook Health Sciences Centre

Information provided by (Responsible Party):

Harvey Quon, CancerCare Manitoba

ClinicalTrials.gov Identifier:

NCT01423474

First received: August 23, 2011

Last updated: February 9, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 23, 2011

Last Updated Date

February 9, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

October 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bowel related quality-of-life [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01423474 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Gastrointestinal toxicity [ Time Frame: During radiotherapy, at 3 and 6 months, then every 6 months after ] [ Designated as safety issue: Yes ]
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
Genitourinary toxicity [ Time Frame: During radiotherapy, at 3 and 6 months, then every 6 months after ] [ Designated as safety issue: Yes ]
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
PSA relapse rate [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]
Biopsy positive rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: During radiotherapy, at 3 and 6 months, then every 6 months after ] [ Designated as safety issue: Yes ]
Salvage androgen deprivation therapy rate [ Time Frame: 3 and 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Prostatic Neoplasms

Intervention ^ICMJE

Radiation: Image-guided radiotherapy
40 Gy / 5 fractions / 11 days
Radiation: Image-guided radiotherapy
40 Gy / 5 fractions / 29 days

Study Arm (s)

Experimental: Short treatment time (11 days)
Intervention: Radiation: Image-guided radiotherapy
Experimental: Long treatment time (29 days)
Intervention: Radiation: Image-guided radiotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

144

Completion Date

Not Provided

Estimated Primary Completion Date

October 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
International Prostate Symptom Score >19
Immunosuppressive medications
Inflammatory bowel disease

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01423474

Other Study ID Numbers ^ICMJE

50-2011

Has Data Monitoring Committee

Yes

Responsible Party

Harvey Quon, CancerCare Manitoba

Study Sponsor ^ICMJE

CancerCare Manitoba

Collaborators ^ICMJE

Sunnybrook Health Sciences Centre

Investigators ^ICMJE

Principal Investigator:	Harvey Quon, MD	CancerCare Manitoba
Principal Investigator:	Andrew Loblaw, MD	Sunnybrook Health Sciences Centre

Information Provided By

CancerCare Manitoba

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top