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Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients (CHIRP)

Primary Purpose

High-risk Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard Radiation Treatment
Hypofractionated radiation treatment
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High-risk Prostate Cancer focused on measuring high risk prostate cancer, hypofractionated radiation treatment, higher biological doses, acceptable rectal toxicity, Radiation Treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Patient is 18 years of age or older
  • Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).
  • Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10
  • No clinical or radiological evidence of nodal or distant metastasis(es).
  • In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.
  • Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
  • No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.
  • No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.
  • No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is > 80%.
  • Patient signed informed consent.

Sites / Locations

  • Cross Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Hypofractionated

Arm Description

Standard Radiation Treatment

Hypofractionated

Outcomes

Primary Outcome Measures

The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients

Secondary Outcome Measures

The biochemical control (freedom from PSA failure) rate
Disease free survival

Full Information

First Posted
December 2, 2011
Last Updated
January 23, 2017
Sponsor
AHS Cancer Control Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01488968
Brief Title
Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients
Acronym
CHIRP
Official Title
A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-risk Prostate Cancer
Keywords
high risk prostate cancer, hypofractionated radiation treatment, higher biological doses, acceptable rectal toxicity, Radiation Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Standard Radiation Treatment
Arm Title
Hypofractionated
Arm Type
Experimental
Arm Description
Hypofractionated
Intervention Type
Radiation
Intervention Name(s)
Standard Radiation Treatment
Intervention Description
39 radiation treatments
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiation treatment
Intervention Description
25 radiation treatments
Primary Outcome Measure Information:
Title
The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
Time Frame
5 years
Secondary Outcome Measure Information:
Title
The biochemical control (freedom from PSA failure) rate
Time Frame
10 years
Title
Disease free survival
Time Frame
10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is 18 years of age or older Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent). Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10 No clinical or radiological evidence of nodal or distant metastasis(es). In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up. Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases. No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy. No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion. No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is > 80%. Patient signed informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albert Murtha
Phone
780-432-8518
Email
albert.murtha@ahs.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Murtha
Organizational Affiliation
Cross Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

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