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

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ClinicalTrials.gov Identifier: NCT01423474
Recruitment Status : Active, not recruiting
First Posted : August 26, 2011
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
British Columbia Cancer Agency
Information provided by (Responsible Party):
Dr. Aldrich Ong, 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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Radiation: Image-guided radiotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : January 2012
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Bowel related quality-of-life [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Gastrointestinal toxicity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 and 5 years ]
  4. Quality of life [ Time Frame: During radiotherapy, at 3 and 6 months, then every 6 months after ]
  5. Salvage androgen deprivation therapy rate [ Time Frame: 3 and 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
  • Immunosuppressive medications
  • Inflammatory bowel disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423474


Locations
Canada, British Columbia
BC Cancer Agency - Abbotsford Centre
Abbotsford, British Columbia, Canada, V2S 0C2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Aldrich Ong, Radiation Oncologist, CancerCare Manitoba
ClinicalTrials.gov Identifier: NCT01423474     History of Changes
Other Study ID Numbers: 50-2011
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Aldrich Ong, CancerCare Manitoba:
Radiotherapy
Hypofractionation

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