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

Primary Purpose

Prostatic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Image-guided radiotherapy
Image-guided radiotherapy
Sponsored by
CancerCare Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Radiotherapy, Hypofractionation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • BC Cancer Agency - Abbotsford Centre
  • CancerCare Manitoba
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Short treatment time (11 days)

Long treatment time (29 days)

Arm Description

Outcomes

Primary Outcome Measures

Bowel related quality-of-life

Secondary Outcome Measures

Gastrointestinal toxicity
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
Genitourinary toxicity
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
PSA relapse rate
Patient Overall Quality of life
Salvage androgen deprivation therapy rate

Full Information

First Posted
August 23, 2011
Last Updated
February 15, 2019
Sponsor
CancerCare Manitoba
Collaborators
Sunnybrook Health Sciences Centre, British Columbia Cancer Agency
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1. Study Identification

Unique Protocol Identification Number
NCT01423474
Brief Title
Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time
Acronym
PATRIOT
Official Title
Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CancerCare Manitoba
Collaborators
Sunnybrook Health Sciences Centre, British Columbia Cancer Agency

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Radiotherapy, Hypofractionation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short treatment time (11 days)
Arm Type
Experimental
Arm Title
Long treatment time (29 days)
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Image-guided radiotherapy
Intervention Description
40 Gy / 5 fractions / 11 days
Intervention Type
Radiation
Intervention Name(s)
Image-guided radiotherapy
Intervention Description
40 Gy / 5 fractions / 29 days
Primary Outcome Measure Information:
Title
Bowel related quality-of-life
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Gastrointestinal toxicity
Description
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
Time Frame
During radiotherapy, at 3 and 6 months, then every 6 months after
Title
Genitourinary toxicity
Description
Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema
Time Frame
During radiotherapy, at 3 and 6 months, then every 6 months after
Title
PSA relapse rate
Time Frame
3 and 5 years
Title
Patient Overall Quality of life
Time Frame
During radiotherapy, at 3 and 6 months, then every 6 months after
Title
Salvage androgen deprivation therapy rate
Time Frame
3 and 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldrich Ong, MD
Organizational Affiliation
CancerCare Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Loblaw, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer Agency - Abbotsford Centre
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 0C2
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29551231
Citation
Quon HC, Ong A, Cheung P, Chu W, Chung HT, Vesprini D, Chowdhury A, Panjwani D, Pang G, Korol R, Davidson M, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Loblaw A. Once-weekly versus every-other-day stereotactic body radiotherapy in patients with prostate cancer (PATRIOT): A phase 2 randomized trial. Radiother Oncol. 2018 May;127(2):206-212. doi: 10.1016/j.radonc.2018.02.029. Epub 2018 Mar 15.
Results Reference
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Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

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