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pHART8: Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01505075
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
120
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).

Condition or Disease Intervention/Treatment Phase
  • Radiation: Hypofractionated radiation
 Phase 1/Phase 2

Detailed Description

Primary Endpoints:
  • Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities
Secondary Endpoints:

  • Late GI and GU Radiation Therapy Oncology Group (RTOG) toxicities

  • Biochemical disease-free survival

  • Biopsy positive rate at 3 years

  • Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

  • Develop a biobank of DNA and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
Actual Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hypofractionated radiation

40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles

Radiation: Hypofractionated radiation
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
Other Names:
  • RapidArc

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of grade 3+ rectal toxicity [Acute period (up to 3 months)]

      Common Terminology Criteria for Adverse Events (CTCAE) v3.0

    Secondary Outcome Measures

    1. Incidence of grade 3+ urinary toxicity [Acute (up to 3 months) and Late (after 6 months of follow-up)]

      Common Terminology Criteria for Adverse Events (CTCAE) v3.0

    2. Quality of Life [5 years]

      Expanded Prostate Cancer Index Composite (EPIC)

    3. Biochemical (ie.prostate specific antigen) disease free survival [5 years]

    4. Incidence of grade 3+ rectal toxicity [Late (after 6 months of follow-up)]

      Common Terminology Criteria for Adverse Events (CTCAE) v3.0

    Eligibility Criteria

    Criteria

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

    • informed consent obtained

    • men > 18 years

    • histologically confirmed prostate adenocarcinoma (centrally reviewed)

    • high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA > 20ng/mL

    Exclusion Criteria:

    • prior pelvic radiotherapy

    • anticoagulation medication (if unsafe to discontinue for gold seed insertion)

    • diagnosis of bleeding diathesis

    • pelvic girth > 40cm (to ensure visibility of gold seeds on electronic portal imaging)

    • large prostate (> 90cm3) on imaging

    • severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia > 3)

    • No evidence of castrate resistance (defined as PSA < 3ng/mL while testosterone is < 0.7nmol/L). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odette Cancer Centre, Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    • Principal Investigator: Andrew Loblaw, MD, FRCPC, Sunnybrook Health Sciences Centre
    • Principal Investigator: Suneil Jain, MD, suneil.jain@sunnybrook.ca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT01505075
    Other Study ID Numbers:
    • 043-2011
    First Posted:
    Jan 6, 2012
    Last Update Posted:
    Nov 24, 2020
    Last Verified:
    Nov 1, 2020
    Keywords provided by Sunnybrook Health Sciences Centre
    prostatic neoplasms
    radiotherapy
    hypofractionated
    high risk prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Nov 24, 2020