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Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer (PHART6)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Hypofractionated radiotherapy
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, Hypofractionation, Low and Intermediate Risk Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Men >18 years
  • Histologically confirmed prostate adenocarcinoma
  • Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Presence of a hip prosthesis
  • Pelvic girth >40cm - Large prostate (>90cm3) on imaging
  • Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT

Arm Description

SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT

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
June 14, 2010
Last Updated
October 2, 2019
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Association of Radiation Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01146340
Brief Title
Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer
Acronym
PHART6
Official Title
Phase I/II Study of Dose-Escalated Hypofractionated Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Association of Radiation Oncology

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 (40 Gy / 5 fractions / 29 days) for the treatment of low- and intermediate-risk prostate cancer.

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, Hypofractionation, Low and Intermediate 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 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBRT
Arm Type
Experimental
Arm Description
SBRT 40 Gy in 5 fractions over 29 days delivered using step and shoot IGRT
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiotherapy
Intervention Description
40 Gy / 5 fractions / 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 (<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 (<3 months) and Late (>6 months)
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 year
Title
Incidence of grade 3+ rectal toxicity
Description
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Time Frame
Late (>6 months)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men >18 years Histologically confirmed prostate adenocarcinoma Low or low-intermediate risk prostate cancer, defined as Clinical stage T1-2b, Gleason Score <=6, and PSA <15 ng/mL, OR Clinical stage T1-2b, Gleason Score 7, and PSA <=10 ng/mL Exclusion Criteria: Prior pelvic radiotherapy Anticoagulation medication (if unsafe to discontinue for gold seed insertion) Diagnosis of bleeding diathesis Presence of a hip prosthesis Pelvic girth >40cm - Large prostate (>90cm3) on imaging Severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia >3)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Loblaw, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harvey Quon, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27622157
Citation
Quon HC, Musunuru HB, Cheung P, Pang G, Mamedov A, D'Alimonte L, Deabreu A, Zhang L, Loblaw A. Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. Front Oncol. 2016 Aug 29;6:185. doi: 10.3389/fonc.2016.00185. eCollection 2016.
Results Reference
derived

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Safety and Efficacy Study of Dose-escalated Hypofractionated Radiotherapy For Prostate Cancer

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