Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000558022
Ethics application status
Approved
Date submitted
7/07/2010
Date registered
12/07/2010
Date last updated
17/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective non-interventional study to evaluate the effect of Triptorelin Embonate (Diphereline (Trademark TM) 11.25mg) on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients.
Scientific title
A prospective non-interventional study to evaluate the effect of Triptorelin Embonate (Diphereline (TM) 11.25mg) on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients.
Secondary ID [1] 252037 0
Ipsen Proprietary Limited
A-9B-52014-179
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally advanced or metastatic prostate cancer with Lower Urinary Tract Symptoms (LUTS) 257579 0
Condition category
Condition code
Cancer 257752 257752 0 0
Prostate
Renal and Urogenital 257888 257888 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study investigating the effect of Triptorelin Embonate (Diphereline (TM) 11.25mg) on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients. The study participation duration for each patient will be 48 weeks. Each subject will receive 4 intramuscular injections of the Triptorelin Embonate (Diphereline (TM) 11.25mg) every 12 weeks at baseline, weeks 12, 24 and 36.
This study is collecting data about the subject’s normal treatment with Triptorelin Embonate (Diphereline (TM)) looking at the effect of this drug on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients. The subject will continue to be treated for prostate cancer according to the best medical practice in Australia. The subject's medical care will not change in anyway as a result of the study and no additional tests or examinations are needed. The only difference will be that subject’s medical details will be recorded not only as it is routinely done in their clinic notes, but also anonymously in an electronic database.
Intervention code [1] 256676 0
Not applicable
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258647 0
Evaluation of the percentage of patients suffering from prostate cancer with moderate to severe LUTS (score International Prostate Symptom Score (IPSS) >7) with at-least 3 points reduction of IPSS score at the end of study week 48 (W48)
Timepoint [1] 258647 0
48 weeks after baseline.
Secondary outcome [1] 264622 0
Evaluation of percentage of patients suffering from prostate cancer with moderate to severe LUTS (score IPSS >7) with at-least 3 points reduction of IPSS score at week 24.
Timepoint [1] 264622 0
24 weeks after baseline.
Secondary outcome [2] 264623 0
Correlation between IPSS score changes and total Prostate Specific Antigen (PSA) changes after 24 weeks of treatment compared to baseline in patients with non-operable prostate cancer presenting moderate to severe LUTS (score IPSS > 7) at baseline.
Timepoint [2] 264623 0
At baseline and at 24 weeks after baseline.
Secondary outcome [3] 264624 0
Correlation between IPSS score changes and total PSA changes after 48 weeks of treatment compared to baseline in patients with prostate cancer presenting moderate to severe LUTS (score IPSS >7) at baseline
Timepoint [3] 264624 0
At baseline and at 48 weeks after baseline.
Secondary outcome [4] 264625 0
The correlation between IPSS score changes and Qmax (Maximum Urinary Flow Rate) as measured by flowmetry changes after 48 weeks of treatment compared to baseline in patients with prostate cancer presenting with moderate to severe LUTS (score IPSS >7) at baseline
Timepoint [4] 264625 0
At baseline and at 48 weeks after baseline.

Eligibility
Key inclusion criteria
1.The patient is suffering from locally-advanced (at least Tumour 3 stage) or metastatic prostate cancer scheduled to receive Diphereline (TM) 11.25mg.
2.The patient is presenting with moderate to severe LUTS ((lower urinary tract symptoms) IPSS score >7).
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1.The patient has a risk of serious complication in the case of tumour flare (vertbral metastases threatening spinal cord compression or significant obstructive uropathy).
2.History of surgical castration.
3.History of urethral stricture.
4.Life expectancy of less than 12 months.
5.Has undergone surgery for the treatment of lower urinary tract symptoms(LUTS).
6.Therapy with a Luteinizing hormone-releasing hormone (LHRH) analogue in the last 6 months.
7. Has received alpha receptor blockers in the last two weeks prior to the start of the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/10/2010
Actual
8/03/2011
Date of last participant enrolment
Anticipated
28/06/2013
Actual
12/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 2103 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [2] 2104 0
Repatriation Hospital - Daw Park
Recruitment hospital [3] 2105 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 2106 0
The Alfred - Prahran
Recruitment hospital [5] 2107 0
Figtree Private Hospital - Figtree
Recruitment hospital [6] 2108 0
Epworth Richmond - Richmond
Recruitment hospital [7] 2109 0
Brisbane Private Hospital - Brisbane
Recruitment hospital [8] 2110 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [9] 2111 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 7795 0
2076 - Wahroonga
Recruitment postcode(s) [2] 7796 0
5041 - Daw Park
Recruitment postcode(s) [3] 7797 0
3084 - Heidelberg
Recruitment postcode(s) [4] 7798 0
3004 - Melbourne
Recruitment postcode(s) [5] 7799 0
2525 - Figtree
Recruitment postcode(s) [6] 7800 0
3121 - Richmond
Recruitment postcode(s) [7] 7801 0
4000 - Brisbane
Recruitment postcode(s) [8] 7802 0
2650 - Wagga Wagga
Recruitment postcode(s) [9] 7803 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 257160 0
Commercial sector/Industry
Name [1] 257160 0
Ipsen Pty Ltd
Country [1] 257160 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ipsen Pty Ltd
Address
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, VIC, 3150
Country
Australia
Secondary sponsor category [1] 256416 0
None
Name [1] 256416 0
Address [1] 256416 0
Country [1] 256416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259282 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 259282 0
Human Research and Ethics Department
Room 2A221
Flinders Medical Centre
Flinders Drive
BEDFORD PARK SA 5042
Ethics committee country [1] 259282 0
Australia
Date submitted for ethics approval [1] 259282 0
19/07/2010
Approval date [1] 259282 0
22/10/2010
Ethics approval number [1] 259282 0
Ethics committee name [2] 290578 0
Adventist HealthCare Ltd HREC
Ethics committee address [2] 290578 0
Adventist HealthCare Limited
Australasian Research Institute Building
185 Fox Valley Road
WAHROONGA NSW 2076
Ethics committee country [2] 290578 0
Australia
Date submitted for ethics approval [2] 290578 0
25/01/2011
Approval date [2] 290578 0
01/04/2011
Ethics approval number [2] 290578 0
EC00141
Ethics committee name [3] 290579 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [3] 290579 0
The Flats G5 Flinders Drive
c/- Flinders Medical Centre
BEDFORD PARK SA 5042
Ethics committee country [3] 290579 0
Australia
Date submitted for ethics approval [3] 290579 0
01/07/2010
Approval date [3] 290579 0
22/10/2010
Ethics approval number [3] 290579 0
EC00188
Ethics committee name [4] 290580 0
Austin Health Human Research Ethics Committee
Ethics committee address [4] 290580 0
Office for Research Harold Stokes Building 145 Studley Rd HEIDELBERG VIC 3084
Ethics committee country [4] 290580 0
Australia
Date submitted for ethics approval [4] 290580 0
13/05/2011
Approval date [4] 290580 0
04/04/2012
Ethics approval number [4] 290580 0
EC00204
Ethics committee name [5] 290581 0
Alfred Hospital Ethics Committee
Ethics committee address [5] 290581 0
Alfred Hospital
Commercial Road
MELBOURNE VIC 3004
Ethics committee country [5] 290581 0
Australia
Date submitted for ethics approval [5] 290581 0
31/05/2012
Approval date [5] 290581 0
14/12/2012
Ethics approval number [5] 290581 0
EC00315
Ethics committee name [6] 290582 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [6] 290582 0
Ethics Unit Building 20,
Level 1 (Research Services Office)
University of Wollongong
WOLLONGONG NSW 2522
Ethics committee country [6] 290582 0
Australia
Date submitted for ethics approval [6] 290582 0
28/02/2011
Approval date [6] 290582 0
11/07/2011
Ethics approval number [6] 290582 0
EC00150
Ethics committee name [7] 290583 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [7] 290583 0
Epworth HealthCare
89 Bridge Road 5LP
RICHMOND VIC 3121
Ethics committee country [7] 290583 0
Australia
Date submitted for ethics approval [7] 290583 0
15/09/2010
Approval date [7] 290583 0
08/10/2010
Ethics approval number [7] 290583 0
EC00217
Ethics committee name [8] 290584 0
Bellberry Human Research Ethics Committee A
Ethics committee address [8] 290584 0
129 Glen Osmond Road
81 Flinders Street
Eastwood SA 5063
Ethics committee country [8] 290584 0
Australia
Date submitted for ethics approval [8] 290584 0
08/08/2011
Approval date [8] 290584 0
29/08/2011
Ethics approval number [8] 290584 0
EC00372
Ethics committee name [9] 290585 0
Mount Hospital Ethics Committee
Ethics committee address [9] 290585 0
Mount Hospital Ethics Committee
150 Mounts Bay Road
PERTH WA 6000
Ethics committee country [9] 290585 0
Australia
Date submitted for ethics approval [9] 290585 0
01/11/2010
Approval date [9] 290585 0
06/04/2011
Ethics approval number [9] 290585 0
EC00387

Summary
Brief summary
This study will collect information from routine clinical care with the intention of evaluating the effect of Diphereline on the symptoms that are present in many men with prostate cancer, such as difficulty in postponing urination, how often they have a weak urinary stream and/or the need to push or strain to begin urination. These symptoms are referred to as lower urinary tract symptoms (LUTS).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31299 0
A/Prof Henry Woo
Address 31299 0
San Clinic, Suite 406
185 Fox Valley Road
Wahroonga, NSW, 2076
Country 31299 0
Australia
Phone 31299 0
+61 2 9473 8765
Fax 31299 0
+61 2 9473 8969
Email 31299 0
[email protected]
Contact person for public queries
Name 14546 0
Mr Jay Dharma
Address 14546 0
Ipsen Pty Ltd.
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, VIC, 3150
Country 14546 0
Australia
Phone 14546 0
+ 61 3 8544 8100
Fax 14546 0
+ 61 3 9562 5152
Email 14546 0
[email protected]
Contact person for scientific queries
Name 5474 0
Dr Monica de Abadal
Address 5474 0
Ipsen Pty Ltd.
Level 2, Building 4, Brandon Office Park,
540 Springvale Road,
Glen Waverley, VIC, 3150
Country 5474 0
Australia
Phone 5474 0
+ 61 3 8544 8100
Fax 5474 0
+61 3 9562 5152
Email 5474 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
EmbaseEffect of triptorelin on lower urinary tract symptoms in Australian prostate cancer patients.2017https://dx.doi.org/10.2147/RRU.S125791
N.B. These documents automatically identified may not have been verified by the study sponsor.