Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001271998
Ethics application status
Approved
Date submitted
8/12/2011
Date registered
12/12/2011
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Micronutrients on Gene Expression in Prostate Cancer: Lycopene
Scientific title
The Impact of Micronutrients on Gene Expression in Prostate Cancer: Lycopene
Secondary ID [1] 273565 0
Nil
Universal Trial Number (UTN)
U1111-1126-3180
Trial acronym
ImoGEX(TM)-PC-Lyc
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 279362 0
Condition category
Condition code
Cancer 285549 285549 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lycopene - oral supplement 3 times daily - 15-90mg for 6-10 weeks; differs on a case-by-case basis as determined by clinician
Intervention code [1] 283867 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286112 0
Global gene expression via blood and tissue analysis
Timepoint [1] 286112 0
Baseline - post-prostatectomy
Secondary outcome [1] 295174 0
A range of markers measured using blood analysis, including: full blood count, PSA, lipids, IGF-1, IGFBP3
Timepoint [1] 295174 0
Baseline - post-prostatectomy

Eligibility
Key inclusion criteria
(1) Age 35-80 years
(2) Non-smoker
(3) Patients with a diagnosis of clinically localised prostate cancer who are scheduled to undergo radical prostatectomy in 6-8 weeks
(4) Normal liver function tests, as verification that the tumour is localized to the prostate gland
Minimum age
35 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
(1) No diagnosis of prostate cancer
(2) Body mass index <18.5kg/m2 (underweight) or >35kg/m2 (obese – class II)
(3) Current infection
(4) Prior therapy for prostate cancer (e.g. chemotherapy; radiation therapy; hormonal therapy)
(5) Current consumption of testosterone replacement medicines
(6) Current consumption of 5-alpha-reductase inhibitors
(7) Consumption of other herbal or nutritional supplements, apart from a single multi-vitamin tablet
(8) Inability to provide informed consent due to diminished understanding or comprehension, or a language other than English spoken and an interpreter unavailable

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



Intervention assignment
Single group
Other design features
Patients serve as their own control
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
An appropriate trial product could not be sourced for this study (lycopene), so a different study in the same area utilising a different intervention was registered with ANZCTR.
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 284350 0
Charities/Societies/Foundations
Name [1] 284350 0
Sanofi Aventis Prostate Cancer Research Award
Country [1] 284350 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 283288 0
None
Name [1] 283288 0
Nil
Address [1] 283288 0
Nil
Country [1] 283288 0
Other collaborator category [1] 260381 0
Other Collaborative groups
Name [1] 260381 0
Mater Medical Research Institute
Address [1] 260381 0
Level 3, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Country [1] 260381 0
Australia
Other collaborator category [2] 260382 0
University
Name [2] 260382 0
Diamantina Institute, The University of Queensland
Address [2] 260382 0
R-Wing
Princess Alexandra Hospital
Ipswich Road, Woolloongabba QLD 4102
Country [2] 260382 0
Australia
Other collaborator category [3] 260383 0
Other Collaborative groups
Name [3] 260383 0
Translational Research Institute
Address [3] 260383 0
Princess Alexandra Hospital
Ipswich Road, Woolloongabba QLD 4102
Country [3] 260383 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286310 0
Greenslopes Private Hospital Human Research Ethics Committee
Ethics committee address [1] 286310 0
Ethics committee country [1] 286310 0
Australia
Date submitted for ethics approval [1] 286310 0
Approval date [1] 286310 0
21/09/2011
Ethics approval number [1] 286310 0
11/40
Ethics committee name [2] 286311 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [2] 286311 0
Ethics committee country [2] 286311 0
Australia
Date submitted for ethics approval [2] 286311 0
06/09/2011
Approval date [2] 286311 0
Ethics approval number [2] 286311 0
1839P

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

Contacts
Principal investigator
Name 33515 0
Dr Olivia Wright
Address 33515 0
School of Human Movement and Nutrition Sciences
The University of Queensland
QLD 4072
Australia
Country 33515 0
Australia
Phone 33515 0
+61 7 33656669
Fax 33515 0
Email 33515 0
o.wright@uq.edu.au
Contact person for public queries
Name 16762 0
Dr Olivia Wright
Address 16762 0
School of Human Movement Studies
Level 5, Connell Building
The University of Queensland
St Lucia QLD 4072
Country 16762 0
Australia
Phone 16762 0
+61 7 3346 7768
Fax 16762 0
+61 7 3365 6877
Email 16762 0
o.wright@uq.edu.au
Contact person for scientific queries
Name 7690 0
Dr Olivia Wright
Address 7690 0
School of Human Movement Studies
Level 5, Connell Building
The University of Queensland
St Lucia QLD 4072
Country 7690 0
Australia
Phone 7690 0
+61 7 3346 7768
Fax 7690 0
+61 7 3365 6877
Email 7690 0
o.wright@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study as it was first registered has been withdrawn.


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.