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Trial registered on ANZCTR


Registration number
ACTRN12608000170325
Ethics application status
Approved
Date submitted
3/04/2008
Date registered
8/04/2008
Date last updated
8/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Assess the Effect of changing testosterone levels on quality of life and physiology in men with prostate cancer undergoing hormone therapy
Scientific title
A Phase II Study to Assess the Effect of Intermittent Androgen Blockade in the Treatment of Advanced Prostate Cancer
Universal Trial Number (UTN)
Trial acronym
GUOG IAB study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 2993 0
Condition category
Condition code
Cancer 3143 3143 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intermittant androgen suppression. Flutamide (Eulexin) 250 mg three times a day and Leuprolide (Lucrin) 22.5 mg three monthly depot for 9 months (this is the treatment phase), at which point patients cease therapy and remain off therapy providing prostate specific antigen (PSA) < 4 ng/mL. Further androgen suppression treatment as above recommenced when the PSA exceeded 20 ng/mL or greater than pretreatment PSA if that was lower.
Intervention code [1] 2734 0
Treatment: Drugs
Intervention code [2] 2752 0
Treatment: Surgery
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4027 0
Quality of life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) + Prostate Module and physiological measures: Full blood count, serum lipids, waist and hip measures, weight, bone turnover markers, Dual Energy X-ray Absorptiometry (DEXA) bone densitometry, fat assessment from DEXA scan, muscle strength by timed stands, lean mass from DEXA scan, Blood pressure (BP), and pulse.
Timepoint [1] 4027 0
Descriptive observational study over 3 years, with assessment 3 monthly. Effect on quality of life at each time point, with BP, weight, hip and waist measures, weight, timed stands, disease activity measured at each time point, DEXA scan assessments at baseline, end of treatment phase (9 months) then at 1 and 2 yeasr after. Bone activity measures at baseline, during treatement and post treatment period.
Secondary outcome [1] 6813 0
None.
Timepoint [1] 6813 0
None.

Eligibility
Key inclusion criteria
Prostate cancer requiring commencement of androgen suppression, and likely to be a candidate for an intermittant program.
Minimum age
Not stated
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prior treatment with hormonal therapy, chemotherapy or biologic response modifiers (other than neoadjuvant hormonal therapy that meets the criteria of 3.1.(i)
b) Patients presenting with acute or impending cord compression.
c) Patients with extensive involvement manifest by a report of ‘superscan’ type uptake pattern.
d) History of prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, or other cancer for which the patient has been disease-free for at least 5 years.
e) Patients with known history of hypersensitivity reaction to either study medication or drugs with a similar structure.

Study design
Purpose of the study
Treatment
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)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3258 0
Commercial sector/Industry
Name [1] 3258 0
Abbott pharmaceuticals Pty Ltd
Address [1] 3258 0
Abbott Australasia Pty Ltd
Abbot Pharmaceuticals Pty Ltd
32-34 Lord Street
Botany NSW 1455
Country [1] 3258 0
Australia
Funding source category [2] 3271 0
Commercial sector/Industry
Name [2] 3271 0
Schering Plough Pty Ltd
Address [2] 3271 0
Schering-Plough Pty Ltd
Level 4
66 Waterloo Road
North Ryde NSW 2113
Telephone: +61 2 89888000
Facsimile: +61 2 8988800
Country [2] 3271 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Abbott pharmaceuticals Pty Ltd
Address
Abbot Pharmaceuticals Pty Ltd
32-34 Lord Street
Botany NSW 1455
Country
Australia
Secondary sponsor category [1] 2925 0
Commercial sector/Industry
Name [1] 2925 0
Schering Plough Pty Ltd
Address [1] 2925 0
Schering-Plough Pty Ltd
Level 4
66 Waterloo Road
North Ryde NSW 2113
Telephone: +61 2 89888000
Facsimile: +61 2 8988800
Country [1] 2925 0
Australia
Other collaborator category [1] 260 0
Other Collaborative groups
Name [1] 260 0
Genito Urinary Oncology Group, NSW.
Address [1] 260 0
Dr Andrew Kneebone
Secretary
Genito Urinary Oncology Group, NSW
Cancer Centre
Elizabeth Street
Liverpool BC NSW 1871
Country [1] 260 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5240 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 5240 0
Verdun Street
Nedlands Perth WA 6009
Ethics committee country [1] 5240 0
Australia
Date submitted for ethics approval [1] 5240 0
19/04/1999
Approval date [1] 5240 0
17/05/1999
Ethics approval number [1] 5240 0
99-040

Summary
Brief summary
1.1 To identify the variation in health related quality of life (HQOL) of patients with advanced prostate cancer treated with intermittent maximal androgen blockade therapy (IMAB).
1.2 To observe the effects of intermittent androgen blockade therapy on the rate and extent of androgen dependent physiological parameters as well as noting serial side effects and patient compliance with the treatment program.
1.3 To gain information regarding time to disease progression and overall survival of patients with advanced prostate cancer treated with intermittent maximal androgen blockade therapy.
1.4 To quantify the relative and absolute amounts of time achieved off treatment from the commencement of active therapy
Trial website
None
Trial related presentations / publications
Longitudinal Quality of Life (QOL) study of Australian men following intermittent maximal androgen blockade for prostate cancer using the EORTC QLQ-C30 + Prostate 26 module
SPRY N.A., Kristjanson L., Hooton B., Hayden L., Neerhut G., Gurney H., Corica T., Korbel E., Weinstein S., McCaul K. Eur J Cancer 42: (6) 1083-92, 2006
galvao changes in muscle and fat, iab study can exercise ameliorate the side effects of ast
3. International study into the use of intermittent therapy in the treatment of carcinoma of the prostate (ISICAP), a meta-analysis of 1443 patients.
Shaw G, Wilson P, Cuzick J, Prowse D, Goldenberg SL, SPRY N, Oliver RTD BJU Int. 2007 May;99(5):1056-65. Epub 2007 Mar 6.
2. International study into the use of intermittent therapy in the treatment of carcinoma of the prostate (ISICAP), a meta-analysis of 1443 patients.
Shaw G, Wilson P, Cuzick J, Prowse D, Goldenberg SL, SPRY N, Oliver RTD
BJU Int. 2007 May;99(5):1056-65. Epub 2007 Mar 6.
Public notes

Contacts
Principal investigator
Name 28488 0
Address 28488 0
Country 28488 0
Phone 28488 0
Fax 28488 0
Email 28488 0
Contact person for public queries
Name 11645 0
Associate Professor Nigel Spry
Address 11645 0
Sir Charles Gairdner Hospital
Block F
Verdun Street
Nedlands WA 6009
Country 11645 0
Australia
Phone 11645 0
+61 8 93464900
Fax 11645 0
Email 11645 0
Jonathan.Gopal@health.wa.gov.au
Contact person for scientific queries
Name 2573 0
Associate Professor Nigel Spry
Address 2573 0
Sir Charles Gairdner Hospital
Block F
Verdun Street
Nedlands WA 6009
Country 2573 0
Australia
Phone 2573 0
+61 8 93464900
Fax 2573 0
Email 2573 0
Jonathan.Gopal@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary