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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
  Purpose

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 Intervention Phase
Prostatic Neoplasms
 Radiation: Image-guided radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of 2 Hypofractionated Radiotherapy Schedules for Low- and Intermediate-Risk Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CancerCare Manitoba:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 144
Study Start Date: January 2012
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • International Prostate Symptom Score >19
  • Immunosuppressive medications
  • Inflammatory bowel disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423474

Locations
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Harvey Quon, MD     (204) 787-2175        
Principal Investigator: Harvey Quon, MD            
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Andrew Loblaw, MD     (416) 480-4806        
Principal Investigator: Andrew Loblaw, MD            
Sponsors and Collaborators
CancerCare Manitoba
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Harvey Quon, MD CancerCare Manitoba
Principal Investigator: Andrew Loblaw, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Harvey Quon, Radiation Oncologist, CancerCare Manitoba
ClinicalTrials.gov Identifier: NCT01423474     History of Changes
Other Study ID Numbers: 50-2011
Study First Received: August 23, 2011
Last Updated: February 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by CancerCare Manitoba:
Radiotherapy
Hypofractionation

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013