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PATRIOT: Prostate Accurately Targeted Radiotherapy Investigation of Overall Treatment Time

Sponsor
CancerCare Manitoba (Other)
Overall Status
Unknown status
CT.gov ID
NCT01423474
Collaborator
Sunnybrook Health Sciences Centre (Other), British Columbia Cancer Agency (Other)
152
Enrollment
3
Locations
2
Arms
105
Duration (Months)
50.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Image-guided radiotherapy
  • Radiation: Image-guided radiotherapy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Short treatment time (11 days)

Radiation: Image-guided radiotherapy
40 Gy / 5 fractions / 11 days
Experimental: Long treatment time (29 days)

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

Outcome Measures

Primary Outcome Measures

  1. Bowel related quality-of-life [3 months]

Secondary Outcome Measures

  1. Gastrointestinal toxicity [During radiotherapy, at 3 and 6 months, then every 6 months after]

    Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema

  2. Genitourinary toxicity [During radiotherapy, at 3 and 6 months, then every 6 months after]

    Radiation Therapy Oncology Group Acute and Late Morbidity Scoring Schema

  3. PSA relapse rate [3 and 5 years]

  4. Patient Overall Quality of life [During radiotherapy, at 3 and 6 months, then every 6 months after]

  5. Salvage androgen deprivation therapy rate [3 and 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 BC Cancer Agency - Abbotsford Centre Abbotsford British Columbia Canada V2S 0C2
2 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
3 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • CancerCare Manitoba
  • Sunnybrook Health Sciences Centre
  • British Columbia Cancer Agency

Investigators

  • Principal Investigator: Aldrich Ong, MD, CancerCare Manitoba
  • Principal Investigator: Andrew Loblaw, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Aldrich Ong, Radiation Oncologist, CancerCare Manitoba
ClinicalTrials.gov Identifier:
NCT01423474
Other Study ID Numbers:
  • 50-2011
First Posted:
Aug 26, 2011
Last Update Posted:
Feb 19, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Dr. Aldrich Ong, Radiation Oncologist, CancerCare Manitoba
Radiotherapy
Hypofractionation
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Feb 19, 2019