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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 082719
ACTR Number: ACTRN12608000170325
Trial Status: Registered
Date Submitted: 3/04/2008
Date Registered: 8/04/2008

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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
ANZCTR registration title: A Phase II Study to Assess the Effect of Intermittent Androgen Blockade in the Treatment of Advanced Prostate Cancer
Secondary ID: 
UTN:
Trial acronym: GUOG IAB study

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

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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:Treatment: drugs 
Intervention code 2:Treatment: surgery 
Comparator / control treatment: None
Control group: Uncontrolled

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Primary outcome: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: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:None. 
Timepoint:None. 

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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
Healthy volunteers? 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.

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Open (masking not used)
Assignment: Single group
Other design features (specify):
Type of endpoint(s): Safety

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Phase Phase 2
Anticipated or actual date of first participant enrolement: 1/05/1999
Target sample size: 250
Recruitment status: Closed: follow-up complete

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

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Sir Charles Gairdner Hospital 
Address:Verdun Street Nedlands Perth WA 6009 
Country:Australia 
Date of approval:17/05/1999 
HREC Number:99-040 
Countries of recruitment:Australia 
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
Presentations / publication list: 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.

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Contact person for public queries
Name: Associate Professor Nigel Spry
Address: Sir Charles Gairdner Hospital
Block F
Verdun Street
Nedlands WA 6009
Country: Australia
Tel: +61 8 93464900
Fax:
Email: Jonathan.Gopal@health.wa.gov.au

Contact person for scientific queries
Name: Associate Professor Nigel Spry
Address: Sir Charles Gairdner Hospital
Block F
Verdun Street
Nedlands WA 6009
Country: Australia
Tel: +61 8 93464900
Fax:
Email: Jonathan.Gopal@health.wa.gov.au

Contact person responsible for updating information
Name: Associate Professor Nigel Spry
Address: Sir Charles Gairdner Hospital
Block F
Verdun Street
Nedlands WA 6009
Country: Australia
Tel: +61 8 93464900
Fax:
Email: Jonathan.Gopal@health.wa.gov.au
   
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