Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000108213
Ethics application status
Approved
Date submitted
19/11/2008
Date registered
16/02/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The utility of 18F-fluro-deoxy-glucose (FDG) and 11C-choline (C) positron emission tomography (PET scan) for radiotheraupetic management of high risk prostate cancer patients
Scientific title
The utility of 18F-fluro-deoxy-glucose (FDG) and 11C-choline (C) positron emission tomography (PET) scan in men with localised prostate cancer planned for radiotheraupetic management
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 3998 0
Condition category
Condition code
Cancer 4197 4197 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 non randomised patients with prostate cancer undergo baseline/staging assessments. This include blood analysis for prostate specific antigen (PSA) levels, 1xcomputed tomography (CT), 1xmagnetic resonance imaging (MRI), 1xbone scan, 1xFDG and 1xC PET scan, with a 24 hour time lapse betweeen the 2 PET scans. Patients then commence androgen deprivation therapy for 3 years. This involves Eligard injections (dose:22.5mg) every 3 months. 3 months into hormone therapy, patients undergo their 2nd set of assessments to evaluate initial hormone response and for planning radiotherapy treatment. This involves 1xCT, 1xMRI, 1xFDG and 1x C PET scan, with a 24 hour time lapse between the 2 PET scans. Patients undergo normal radiotherapy treatments for 8weeks, 5 days/week. About 9 months into hormone therapy (and 4 months after radiotherapy), patients undergo their 3rd set of assessments involving 1xCT, 1xMRI, 1xFDG and 1xC scan, with 24 hour time lapse between the 2 PET scans. The 4th and final set of assessments are conducted at the end of study, that is 5 years after commencement into study (ie 2 years after completing their hormone therapy). This involve blood analysis for PSA levels, 1x CT, 1xMRI, 1xFDG and 1xC scan, with a 24 hour time lapse between the 2 PET scans
Intervention code [1] 3723 0
Diagnosis / Prognosis
Comparator / control treatment
Non randomised study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5093 0
Concordance of Choline and FDG PET with the standard imaging technologies, computed tomography (CT) and magnetic resonance imaging (MRI) by comparing the different scan results
Timepoint [1] 5093 0
Time=0 baseline/staging images, time= 3 months for radiotherapy treatment planning and time = 8 months for post radiotherapy review
Secondary outcome [1] 8562 0
Prostate specific antigen (PSA) levels, using blood analysis.
Timepoint [1] 8562 0
Time = 0 to evaluate baseline levels, time = Week 8 to determine initial hormone response, and time = 5 years for end of study review.
Post radiotherapy recurrence is identified either from biochemical (rising PSA levels) or clinical (physical examination) treatment failure.

Eligibility
Key inclusion criteria
PSA > 20 or Gleason score 8-10 or T stage T3a,T3b or T4
Age > 18 years
Eastern Cooperative Oncology Group Performance Status (ECOG) 0 or 1
No significant medical or psychiatric illness
Written informed consent
Be prepared to undergo PET scanning
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Any form of prostate malignancy
T1-2c prostate cancer and PSA , 10 and Gleason score < 7
Previous radical prostatectomy
Known metastatic prostate cancer
Contraindication to MRI
Contraindication to androgen ablation
Contraindication to PET
Commencement of androgen depriavation therapy prior to study entry
Previous pelvic radiotherapy
Contraindication to radiotherapy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4188 0
Government body
Name [1] 4188 0
National Health and Medical Research Council (NHMRC)
Country [1] 4188 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg 3084
VIC
Country
Australia
Secondary sponsor category [1] 3762 0
None
Name [1] 3762 0
Address [1] 3762 0
Country [1] 3762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6242 0
HREC Austin Health
Ethics committee address [1] 6242 0
Ethics committee country [1] 6242 0
Australia
Date submitted for ethics approval [1] 6242 0
Approval date [1] 6242 0
Ethics approval number [1] 6242 0
H2008/03284

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

Contacts
Principal investigator
Name 29146 0
Address 29146 0
Country 29146 0
Phone 29146 0
Fax 29146 0
Email 29146 0
Contact person for public queries
Name 12303 0
Lekshmy Shanker
Address 12303 0
Room 8244
Harold Stokes Building
145 Studley Road
Heidelberg 3084
VIC
Country 12303 0
Australia
Phone 12303 0
+61 3 9496 3965
Fax 12303 0
+61 3 9496 5749
Email 12303 0
lekshmy.shanker@ludwig.edu.au
Contact person for scientific queries
Name 3231 0
Dr Daryl Lim Joon
Address 3231 0
Radiation Oncology Centre
Austin Health
330 Waterdale Road
Heidelber West 3081
VIC
Country 3231 0
Australia
Phone 3231 0
+61 3 9496 2800
Fax 3231 0
Email 3231 0
Daryl.LIMJOON@austin.org.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.