Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

Not Applicable

• Conditions: High-risk Prostate Cancer
• Interventions: Radiation: Hypofractionated radiation treatment; Radiation: Standard Radiation Treatment

• Registration Number: NCT01488968
• Lead Sponsor: AHS Cancer Control Alberta

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-09
• Study Start: 2012-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25
• Primary Completion: 2018-01
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 134

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated	Hypofractionated radiation treatment	Hypofractionated
Standard	Standard Radiation Treatment	Standard Radiation Treatment

Primary Outcome Measures

Name	Time	Method
The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients	5 years

Secondary Outcome Measures

Name	Time	Method
The biochemical control (freedom from PSA failure) rate	10 years
Disease free survival	10 years

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada