Clinical trial NCT00201916: Shorter Radiation Schedule for the Treatment of Prostate Cancer
Official title: A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
prostate specific antigen
PSA
radiation fractionation
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: NCIC Clinical Trials Group
First posted: 2005-09-20
Enrollment: 936
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To improve the management of patients with early stage prostate cancer.

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 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

Primary outcomes:
measure: time to PSA failure
timeFrame: 10 years
Secondary outcomes:
measure: positive biopsy at two years post radiation
timeFrame: see above
measure: disease free survival
timeFrame: 10 years
measure: toxicity
timeFrame: 10 years
measure: quality of life
timeFrame: 6 years
measure: economic
timeFrame: 10 years
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: B.C. Cancer Agency - Fraser Valley Cancer Centre
state: British Columbia
city: Vancouver
country: Canada
facility: B. C. Cancer Agency - Vancouver Cancer Clinic
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Moncton
country: Canada
facility: Dr. Leon Richard Oncology Centre
state: New Brunswick
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: St. John's
country: Canada
facility: Newfoundland Cancer Clinic
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto-Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network -Princess Margaret Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Juravinski Cancer Centre
name: Himu Lukka, MD
role: STUDY_CHAIR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Charles Hayter, MD
role: STUDY_CHAIR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.