Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

High-risk Prostate Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01488968
• Other study ID #: 25859
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2011
• Last updated: January 23, 2017
• Start date: March 2012
• Est. completion date: December 2021

Study information

• Verified date: January 2017
• Source: AHS Cancer Control Alberta
• Contact: Albert Murtha
• Phone: 780-432-8518
• Email: albert.murtha[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: December 2021
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• High-risk Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Standard Radiation Treatment
39 radiation treatments
• Hypofractionated radiation treatment
25 radiation treatments

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients		5 years
Secondary	The biochemical control (freedom from PSA failure) rate		10 years
Secondary	Disease free survival		10 years