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.

AHS Cancer Control Alberta1 site in 1 country111 target enrollmentMarch 1, 2012

ConditionsHigh-risk Prostate Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: High-risk Prostate Cancer
Sponsor: AHS Cancer Control Alberta
Enrollment: 111
Locations: 1
Primary Endpoint: The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
Status: Terminated
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2012

End Date

October 15, 2018

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

AHS Cancer Control Alberta

Responsible Party

Sponsor

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.