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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Hypofractionated radiation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostatic neoplasms, radiotherapy, hypofractionated, high risk prostate cancer

Eligibility Criteria

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

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

Sites / Locations

  • Odette Cancer Centre, Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated radiation

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of grade 3+ rectal toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Secondary Outcome Measures

Incidence of grade 3+ urinary toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Quality of Life
Expanded Prostate Cancer Index Composite (EPIC)
Biochemical (ie.prostate specific antigen) disease free survival
Incidence of grade 3+ rectal toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Full Information

First Posted
October 5, 2011
Last Updated
November 23, 2020
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01505075
Brief Title
Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer
Acronym
pHART8
Official Title
Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostatic neoplasms, radiotherapy, hypofractionated, high risk prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated radiation
Arm Type
Experimental
Arm Description
40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiation
Other Intervention Name(s)
RapidArc
Intervention Description
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
Primary Outcome Measure Information:
Title
Incidence of grade 3+ rectal toxicity
Description
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Time Frame
Acute period (up to 3 months)
Secondary Outcome Measure Information:
Title
Incidence of grade 3+ urinary toxicity
Description
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Time Frame
Acute (up to 3 months) and Late (after 6 months of follow-up)
Title
Quality of Life
Description
Expanded Prostate Cancer Index Composite (EPIC)
Time Frame
5 years
Title
Biochemical (ie.prostate specific antigen) disease free survival
Time Frame
5 years
Title
Incidence of grade 3+ rectal toxicity
Description
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Time Frame
Late (after 6 months of follow-up)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Loblaw, MD, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suneil Jain, MD
Organizational Affiliation
suneil.jain@sunnybrook.ca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odette Cancer Centre, Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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