Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001166460
Ethics application status
Approved
Date submitted
15/08/2016
Date registered
26/08/2016
Date last updated
11/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Novel Liver Targeted Testosterone Therapy for Sarcopenia in Androgen Deprived Men with Prostate Cancer - A Blinded Randomized Controlled Trial
Scientific title
A Novel Liver Targeted Testosterone Therapy for Sarcopenia in Androgen Deprived Men with Prostate Cancer - A Blinded Randomized Controlled Trial
Secondary ID [1] 289807 0
nil known
Universal Trial Number (UTN)
U1111-1185-9549
Trial acronym
SADMCAP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 299727 0
Sarcopenia 299728 0
Androgen Deprivation Therapy 299729 0
Condition category
Condition code
Metabolic and Endocrine 299661 299661 0 0
Other metabolic disorders
Cancer 299662 299662 0 0
Prostate
Musculoskeletal 299825 299825 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40mg oral testosterone daily for 6 months

Will monitor adherence by patient log and drug packet return
Intervention code [1] 295482 0
Treatment: Drugs
Comparator / control treatment
Placebo for 6 months - microcellulose
Control group
Placebo

Outcomes
Primary outcome [1] 299125 0
Measure of lean body mass after 6 months enrolment
Aim for difference between treatment and placebo arms of 1.6kg at 80% power with 0.05 significance
Will assess using DEXA scan
Timepoint [1] 299125 0
6 months post commencement of intervention
Secondary outcome [1] 326251 0
Prostate cancer progression
Assessed by PSA test
Timepoint [1] 326251 0
6 months post commencement of intervention

Eligibility
Key inclusion criteria
All men with prostate cancer on Androgen Deprivation therapy
- no time limit regarding diagnosis
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
50% increase in PSA or increase in PSA to >4nmol/L above baseline after commencement of intervention
Previous Thyroid Dysfunction
Serious adverse event caused by product
Participants decision to withdrawl

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using block design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Proof of concept analysis
Assuming that treatment maintains LBM over 6 months, a sample size of 25 per group is required to achieve a significance difference 1.6kg LBM at 0.05 significance with 80% power between treatment and placebo. The present study sample size allows for a 10% drop out.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/08/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
50
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6343 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 6344 0
Greenslopes Private Hospital - Greenslopes
Recruitment postcode(s) [1] 13885 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 13886 0
4120 - Greenslopes

Funding & Sponsors
Funding source category [1] 294194 0
Charities/Societies/Foundations
Name [1] 294194 0
Prostate Cancer Foundation Australia
Country [1] 294194 0
Australia
Primary sponsor type
Hospital
Name
Metro South Health and Hospital Service
Address
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba, QLD 4102
Country
Australia
Secondary sponsor category [1] 293018 0
Charities/Societies/Foundations
Name [1] 293018 0
Prostate Cancer Foundation Australia
Address [1] 293018 0
PO Box 499
St Leonards NSW 1590
Australia
Country [1] 293018 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295597 0
Metro South HHS Human Research Ethics Committee
Ethics committee address [1] 295597 0
Metro South HHS Human Research Ethics Committee
Princess Alexandra Hospital
Ipswich Rd
Wooloongabba
QLD 4102
Ethics committee country [1] 295597 0
Australia
Date submitted for ethics approval [1] 295597 0
10/02/2016
Approval date [1] 295597 0
20/04/2016
Ethics approval number [1] 295597 0
HREC/16/QPAH/105

Summary
Brief summary
The primary purpose of this trial is to evaluate the efficacy of oral testosterone for the prevention and treatment of sarcopenia in men with prostate cancer on Androgen Deprivation Therapy (ADT).

Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with prostate cancer, for which you are undergoing ADT.

Study details
All participants enrolled in this study will be randomly allocated (by chance) to receive either oral testosterone once per day for six months, or to receive an inactive sham tablet once per day for six months. All participants will be reviewed for sarcopenia by assessment of muscle mass with DEXA at six months, and for prostate cancer progression by PSA.

It is hoped that the findings from this trial will provide information on the efficacy of oral testosterone for the prevention of sarcopenia in patients commencing ADT and the reversal of sarcopenia in patients on long term ADT, whilst evaluating whether this treatment has any impact on prostate cancer progression.
Trial website
nil
Trial related presentations / publications
Public notes
Attachments [1] 982 982 0 0
/AnzctrAttachments/370868-2016_March_15 Ho PICF VERSION 2._KHdoc.doc

Contacts
Principal investigator
Name 66530 0
Prof Ken Ho
Address 66530 0
c/o Maria Wojciechowski,
Project Officer & ESO to Professor Ken Ho & Paul Dall’Alba
Centres for Health Research Metro South Health
Level 7, Translational Research Institute, 37 Kent Street, WOOLLOONGABBA QLD 4102
Country 66530 0
Australia
Phone 66530 0
+61 7 34438066
Fax 66530 0
Email 66530 0
[email protected]
Contact person for public queries
Name 66531 0
Prof Ken Ho
Address 66531 0
c/o Maria Wojciechowski, Project Officer & ESO to Professor Ken Ho & Paul Dall’Alba Centres for Health Research Metro South Health Level 7, Translational Research Institute, 37 Kent Street, WOOLLOONGABBA QLD 4102 a
Country 66531 0
Australia
Phone 66531 0
+61 7 34438066
Fax 66531 0
Email 66531 0
[email protected]
Contact person for scientific queries
Name 66532 0
Prof Ken Ho
Address 66532 0
c/o Maria Wojciechowski, Project Officer & ESO to Professor Ken Ho, Centres for Health Research Metro South Health Level 7, Translational Research Institute, 37 Kent Street, WOOLLOONGABBA QLD 4102
Country 66532 0
Australia
Phone 66532 0
+61 7 34438066
Fax 66532 0
Email 66532 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseA Novel Liver-Targeted Testosterone Therapy for Sarcopenia in Androgen Deprived Men with Prostate Cancer.2021https://dx.doi.org/10.1210/jendso/bvab116
N.B. These documents automatically identified may not have been verified by the study sponsor.