Shorter Radiation Schedule for the Treatment of Prostate Cancer
A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
2 other identifiers
interventional
936
1 country
16
Brief Summary
To improve the management of patients with early stage prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Mar 1995
Longer than P75 for phase_3 prostate-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1995
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 17, 2010
August 1, 2010
13.8 years
September 13, 2005
August 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to PSA failure
10 years
Secondary Outcomes (5)
positive biopsy at two years post radiation
see above
disease free survival
10 years
toxicity
10 years
quality of life
6 years
economic
10 years
Study Arms (2)
1
EXPERIMENTAL5250 cGy in 20 fractions over 28 days
2
ACTIVE COMPARATOR6600 cGy in 33 fractions over 45 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ontario Clinical Oncology Group (OCOG)lead
- NCIC Clinical Trials Groupcollaborator
Study Sites (16)
B.C. Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2, Canada
B. C. Cancer Agency - Vancouver Cancer Clinic
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland Cancer Clinic
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7A 7T1, Canada
Toronto-Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network -Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (1)
Lukka H, Hayter C, Julian JA, Warde P, Morris WJ, Gospodarowicz M, Levine M, Sathya J, Choo R, Prichard H, Brundage M, Kwan W. Randomized trial comparing two fractionation schedules for patients with localized prostate cancer. J Clin Oncol. 2005 Sep 1;23(25):6132-8. doi: 10.1200/JCO.2005.06.153.
PMID: 16135479RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
March 1, 1995
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
August 17, 2010
Record last verified: 2010-08