Shorter Radiation Schedule for the Treatment of Prostate Cancer
This study has been completed.
Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborator:
NCIC Clinical Trials Group
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00201916
First received: September 13, 2005
Last updated: August 16, 2010
Last verified: August 2010
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Purpose
To improve the management of patients with early stage prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: 5250 cGy/20 fractions over 28 days Procedure: 6600 cGy/33 fractions over 45 days |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Ontario Clinical Oncology Group (OCOG):
Primary Outcome Measures:
- time to PSA failure [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- positive biopsy at two years post radiation [ Time Frame: see above ] [ Designated as safety issue: No ]
- disease free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- toxicity [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- quality of life [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- economic [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Enrollment: | 936 |
| Study Start Date: | March 1995 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
5250 cGy in 20 fractions over 28 days
|
Procedure: 5250 cGy/20 fractions over 28 days
see above
Other Name: short fractionation schedule
|
|
Active Comparator: 2
6600 cGy in 33 fractions over 45 days
|
Procedure: 6600 cGy/33 fractions over 45 days
see above
Other Name: standard
|
Detailed Description:
To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
- stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification
Exclusion Criteria:
- PSA > 40 mcg/L
- previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
- prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
- simulated volume exceeds 1000 cm3
- previous pelvic radiotherapy
- inflammatory bowel disease
- serious non-malignant disease which would preclude radiotherapy or surgical biopsy
- geographic inaccessibility for follow-up
- psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol
- unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy
- failure to give informed consent to participate in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201916
Locations
| Canada, British Columbia | |
| B.C. Cancer Agency - Fraser Valley Cancer Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| B. C. Cancer Agency - Vancouver Cancer Clinic | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Dr. Leon Richard Oncology Centre | |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Saint John Regional Hospital | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Newfoundland Cancer Clinic | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Northeastern Ontario Regional Cancer Centre | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Thunder Bay Regional Health Sciences Centre | |
| Thunder Bay, Ontario, Canada, P7A 7T1 | |
| Toronto-Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| University Health Network -Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Windsor Regional Cancer Centre | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
NCIC Clinical Trials Group
Investigators
| Study Chair: | Himu Lukka, MD | Juravinski Cancer Centre |
| Study Chair: | Charles Hayter, MD | Toronto Sunnybrook Regional Cancer Centre |
| Principal Investigator: | Mark Levine, MD | Ontario Clinical Oncology Group (OCOG) |
More Information
Publications:
| Responsible Party: | Dr. Mark Levine, Ontario Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00201916 History of Changes |
| Other Study ID Numbers: | OCOG-1995-PR.5, CAN-OCOG-V95-0687 |
| Study First Received: | September 13, 2005 |
| Last Updated: | August 16, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
prostate cancer prostate specific antigen PSA radiation fractionation |
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 May 22, 2013