Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000566730
Ethics application status
Approved
Date submitted
6/05/2013
Date registered
20/05/2013
Date last updated
23/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Natural Course of Hot Flash Symptoms in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer – a Pilot Investigation.
Scientific title
In men receiving androgen-deprivation therapy for histologically confirmed prostate cancer, what is the natural course of hot flash symptoms?
Secondary ID [1] 282421 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Natural course of hot flashes in men with prostate cancer, receiving ADT for the first time. 289014 0
Condition category
Condition code
Cancer 289353 289353 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This pilot study will prospectively follow a cohort of 20 men with hormone naive prostate cancer who have been commenced on ADT in the form of LHRH analogues. This study will be conducted over a total of three years. Participants will be asked to complete a Hot Flash Score form. The Hot Flash Score will be measured at 1, 2 and 3 months following the initiation of androgen-deprivation therapy, and then every 3 months for total twelve-month period. Hot Flash score forms will be completed 6-monthly thereafter, for the remainder of the observation period. In addition to the Hot Flash Score, patients will have their baseline and progression testosterone and Prostate Specific Antigen (PSA) levels measured as part of their standard of care. No additional pathology tests will be undertaken compared to men who would otherwise not be enrolled in this study.
Intervention code [1] 287057 0
Not applicable
Comparator / control treatment
Nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289465 0
The primary objectives of this study is to determine the natural course of hot flash symptoms in men with receiving ADT for histologically confirmed, hormone-naive prostate cancer.

Men will complete a validated questionnaire called the Hot Flash Score. This will be completed at 1, 2, 3, 6, 9 and 12 months following the commencement of ADT. Thereafter, it will be carried out on a 6 monthly basis until completion of the study at 3 years.
Timepoint [1] 289465 0
The study cohort will be followed for a total of three years. The suggested clinical observation period is monthly for the first three months, three-monthly for the first year, and six-monthly thereafter, until the total three-year observation period concludes.
Secondary outcome [1] 302549 0
1. To measure the frequency and severity of hot flash symptoms in men receiving ADT using a validated hot flash instrument.
Timepoint [1] 302549 0
The Hot Flash Score will be measured at 1, 2 and 3 months following commencement of ADT and every thereafter 3 months until 12 months following commencement of ADT. For the remainder of the observation period, the Hot Flash Score will be completed every 6 months.
Secondary outcome [2] 302750 0
2. To record any impact that testosterone and PSA levels may have on recorded hot flashes.
Timepoint [2] 302750 0
Testosterone will be measured at 3 and 12 months. PSA will be measured at three months, and then every three months thereafter for the first twelve months. PSA will be measured six-monthly thereafter, until the end of the three year observation period.

Eligibility
Key inclusion criteria
Men with histologically confirmed and hormone-naive prostate cancer, being commence on androgen-deprivation therapy for the first time.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include previous androgen-deprivation therapy, participant inability to complete a hot flash score independently, and an ECOG status of 2 or more.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A student T-test will be used for parametric data and Wilcoxon matched pairs for non-parametric data. Categorical analysis will be conducted using a Chi Square test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287194 0
Self funded/Unfunded
Name [1] 287194 0
A/Prof Henry Woo,
Country [1] 287194 0
Australia
Primary sponsor type
Individual
Name
A/Professor Henry Woo
Address
Suite 406, SAN Clinic, 185 Fox Valley Road, Wahroonga.
Country
Australia
Secondary sponsor category [1] 285958 0
Individual
Name [1] 285958 0
Dr Cindy Garcia
Address [1] 285958 0
Hornsby Hospital, Palmerston Rd Hornsby NSW 2077, Australia.
Country [1] 285958 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289188 0
Sydney Adventist Hospital (SAH) Ethics Committee
Ethics committee address [1] 289188 0
185 Fox Valley Road
WAHROONGA NSW 2076
Ethics committee country [1] 289188 0
Australia
Date submitted for ethics approval [1] 289188 0
Approval date [1] 289188 0
29/04/2013
Ethics approval number [1] 289188 0

Summary
Brief summary
This study is observing the natural course of hot flash symptoms in men receiving androgen deprivation therapy (ADT) in the form of luteinizing hormone releasing hormone (LHRH) analogues for histologically confirmed hormone-naive prostate cancer.

Who is it for?
You may be eligible to join this study if you are a male with histologically confirmed and hormone-naive prostate cancer and have commenced on ADT in the form of LHRH analogues for the first time.

Trial details
In this study, you will be observed for a total period of 3 years. You will be required to complete a validated questionnaire called the Hot Flash Score. This will need to be completed at 1, 2, 3, 6, 9 and 12 months following commencement of ADT. Thereafter, you will be required to complete the Hot Flash Score questionnaire every 6 months until the completion of the study at 3 years. All other treatment and investigations will be carried out according to standard care – that is, no additional pathology tests will be undertaken compared to men who would otherwise not be enrolled in this study.
Trial website

Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39674 0
A/Prof Henry Woo
Address 39674 0
Sydney Adventist Hospital, Suite 406, SAN Clinic. 185 Fox Valley Road, Wahroonga. NSW. 2076.
Country 39674 0
Australia
Phone 39674 0
+61 2 9473 8850
Fax 39674 0
Email 39674 0
hwoo@urologist.net.au
Contact person for public queries
Name 39675 0
Dr Cindy Garcia
Address 39675 0
Hornsby Hospital, Palmerston Rd Hornsby NSW 2077, Australia.
Country 39675 0
Australia
Phone 39675 0
+61 2 9477 9123
Fax 39675 0
Email 39675 0
cindy.jc.garcia@gmail.com
Contact person for scientific queries
Name 39676 0
Dr Cindy Garcia
Address 39676 0
Hornsby Hospital, Palmerston Rd Hornsby NSW 2077, Australia.
Country 39676 0
Australia
Phone 39676 0
+61 2 9477 9123
Fax 39676 0
Email 39676 0
cindy.jc.garcia@gmail.com

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
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