Skip to content

Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01488968
Acronym
CHIRP
Enrollment
111
Registered
2011-12-09
Start date
2012-03-31
Completion date
2018-10-15
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk Prostate Cancer

Keywords

high risk prostate cancer, hypofractionated radiation treatment, higher biological doses, acceptable rectal toxicity, Radiation Treatment

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.

Interventions

39 radiation treatments

25 radiation treatments

Sponsors

AHS Cancer Control Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients5 years

Secondary

MeasureTime frame
The biochemical control (freedom from PSA failure) rate10 years
Disease free survival10 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026