Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients
CHIRP
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.
1 other identifier
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2011
CompletedFirst Posted
Study publicly available on registry
December 9, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2018
CompletedJune 29, 2025
January 1, 2017
6.6 years
December 2, 2011
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
5 years
Secondary Outcomes (2)
The biochemical control (freedom from PSA failure) rate
10 years
Disease free survival
10 years
Study Arms (2)
Standard
ACTIVE COMPARATORStandard Radiation Treatment
Hypofractionated
EXPERIMENTALHypofractionated
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Murtha
Cross Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2011
First Posted
December 9, 2011
Study Start
March 1, 2012
Primary Completion
October 15, 2018
Study Completion
October 15, 2018
Last Updated
June 29, 2025
Record last verified: 2017-01