Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00304759




Registration number
NCT00304759
Ethics application status
Date submitted
17/03/2006
Date registered
20/03/2006
Date last updated
31/07/2017

Titles & IDs
Public title
PROFIT - Prostate Fractionated Irradiation Trial
Scientific title
A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
Secondary ID [1] 0 0
CIHR grant MCT-78776
Secondary ID [2] 0 0
OCOG-2005-PROFIT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - 7800 cGy/39 fractions in 8 weeks
Treatment: Surgery - 6000 cGy/20 fractions in 4 weeks

Experimental: 1 - 6000 cGy / 20 fractions in 4 weeks

Active comparator: 2 - 7800 cGy / 39 fractions in 8 weeks


Treatment: Surgery: 7800 cGy/39 fractions in 8 weeks
see above

Treatment: Surgery: 6000 cGy/20 fractions in 4 weeks
see above
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Biochemical (PSA) Failure
Timepoint [1] 0 0
five years
Secondary outcome [1] 0 0
Biochemical-Clinical Failure
Timepoint [1] 0 0
five years
Secondary outcome [2] 0 0
Prostate Cancer Specific Mortality
Timepoint [2] 0 0
five years
Secondary outcome [3] 0 0
Toxicity
Timepoint [3] 0 0
five years
Secondary outcome [4] 0 0
Quality of Life
Timepoint [4] 0 0
five years

Eligibility
Key inclusion criteria
1. Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung;
2. Intermediate risk prostate cancer (that is, T1-2a, Gleason score <6, PSA 10.1-20.0 ng/ml; T2b-c Gleason <6, PSA = 20.0 ng/ml; T1-2, Gleason 7, PSA = 20.0 ng/ml).
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry;
2. Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection;
3. Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer;
4. Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer;
5. Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial;
6. Previous pelvic radiotherapy;
7. Inflammatory bowel disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/07/2017
Sample size
Target
1204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital & Campbelltown Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle Hospital - Newcastle
Recruitment hospital [3] 0 0
Northern Sydney Cancer Centre, Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
Westmead Cancer Care Centre - Wentworthville
Recruitment hospital [5] 0 0
Wollongong Hospital / Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [6] 0 0
Toowoomba Cancer Research Centre - Toowoomba
Recruitment hospital [7] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [8] 0 0
Ballarat Austin Radiation Oncology Centre (BAROC) - Ballarat
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2310 - Newcastle
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment postcode(s) [4] 0 0
2145 - Wentworthville
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4350 - Toowoomba
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
3350 - Ballarat
Recruitment postcode(s) [9] 0 0
8006 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Newfoundland and Labrador
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Canada
State/province [6] 0 0
Saskatchewan
Country [7] 0 0
France
State/province [7] 0 0
Saint Herblain

Funding & Sponsors
Primary sponsor type
Other
Name
Ontario Clinical Oncology Group (OCOG)
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Trans Tasman Radiation Oncology Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charles Catton, MD
Address 0 0
Princess Margaret Hospital, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00304759