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Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients

This study is currently recruiting participants.
Verified December 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01488968
First received: December 2, 2011
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
High-risk Prostate Cancer
 Radiation: Standard Radiation Treatment
Radiation: Hypofractionated radiation treatment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The biochemical control (freedom from PSA failure) rate [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 134
Study Start Date: March 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard
Standard Radiation Treatment
 Radiation: Standard Radiation Treatment
39 radiation treatments
Experimental: Hypofractionated
Hypofractionated
 Radiation: Hypofractionated radiation treatment
25 radiation treatments

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488968

Contacts
Contact: Nadeem Pervez 780-432-8517 nadeem.pervez@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Nadeem Pervez Cross Cancer Institute
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT01488968     History of Changes
Other Study ID Numbers: Pervez 11/30/2011 25859
Study First Received: December 2, 2011
Last Updated: December 10, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
high risk prostate cancer
hypofractionated radiation treatment
higher biological doses
acceptable rectal toxicity
Radiation Treatment

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013