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Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients (CHIRP)

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ClinicalTrials.gov Identifier: NCT01488968
Recruitment Status : Recruiting
First Posted : December 9, 2011
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
High-risk Prostate Cancer Radiation: Standard Radiation Treatment Radiation: Hypofractionated radiation treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Standard
Standard Radiation Treatment
Radiation: Standard Radiation Treatment
39 radiation treatments

Experimental: Hypofractionated
Hypofractionated
Radiation: Hypofractionated radiation treatment
25 radiation treatments




Primary Outcome Measures :
  1. The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. The biochemical control (freedom from PSA failure) rate [ Time Frame: 10 years ]
  2. Disease free survival [ Time Frame: 10 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488968


Contacts
Contact: Albert Murtha 780-432-8518 albert.murtha@ahs.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Albert Murtha Cross Cancer Institute

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01488968     History of Changes
Other Study ID Numbers: 25859
First Posted: December 9, 2011    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by AHS Cancer Control Alberta:
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