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ISRCTN
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ISRCTN47114653
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ClinicalTrials.gov identifier
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Public title
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An open-label, prospective, comparative trial to assess prostate specific antigen progression on bicalutamide monotherapy versus bicalutamide and dutasteride therapy in patients with advanced and/or metastatic carcinoma of the prostate
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Scientific title
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Acronym
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AVOCAT study
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Serial number at source
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N/A
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Study hypothesis
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To evaluate the difference in percentages of patients with Prostate Specific Antigen (PSA) progression treated with either bicalutamide 150 mg/day in monotherapy or bicalutamide 150 mg/day and dutasteride 0.5 mg/day after three years of follow-up in patients with locally advanced or metastatic prostate cancer.
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Lay summary
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Ethics approval
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Approval received from the Committee Human Research region Arnhem-Nijmegen (The Netherlands)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Prostate Cancer
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Participants - inclusion criteria
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1. Patients aged 18 years and above
2. Patients with histologically proven prostate cancer
3. Patients with locally advanced carcinoma of the prostate (T3-4, N0-x) or (T0-x, N1-3; N category should be confirmed histologically or cytologically) or metastatic carcinoma of the prostate (M1)
4. Patients with a high (more than 10 ng/ml) PSA level at baseline
5. Written informed consent to participate in the study
6. Life expectancy is at least 12 months
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Participants - exclusion criteria
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1. Patients simultaneously participating in another study
2. Previous or concurrent chemotherapy, 5-alpha reductase inhibitor therapy or hormonal therapy specifically for the treatment of prostate cancer other than temporary neo-adjuvant hormonal therapy administered longer than one year prior to study entry
3. Development of another invasive neoplastic disease during the previous five years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
4. Patients with a history or presence of hepatic or renal disease or other condition known to interfere with metabolism or excretion of drugs
5. Patients with a history of alcohol or drug abuse
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Anticipated start date
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01/03/2006
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Anticipated end date
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31/03/2012
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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324
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Interventions
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Group one will be hormonally treated with bicalutamide 150 mg/day monotherapy.
Group two will be hormonally treated with bicalutamide 150 mg/day and 0.5 mg dutasteride/day.
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Primary outcome measure(s)
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PSA progression after three years of study treatment.
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Secondary outcome measure(s)
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1. Quality of life
2. Performance Status
3. Disease progression
4. Survival
5. Nature and number of Adverse Events (AEs)
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Sources of funding
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Foundation for the Promotion of Urological Scientific Research (Stichting ter bevordering van het Wetenschappelijk Urologisch onderzoek [STIWU]) (The Netherlands)
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Trial website
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http://www.curatrial.com
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Publications
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Contact name
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Dr
W J
de Bruijn
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Address
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CuraTrial
P.O. Box 30016
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City/town
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Arnhem
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Zip/Postcode
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6803 AA
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Country
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Netherlands
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Tel
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+31 (0)26 3890677
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Fax
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+31 (0)26 3890679
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Email
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w.debruijn@curatrial.com
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Sponsor
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Foundation for the Promotion of Urological Scientific Research (STIWU) (The Netherlands)
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Address
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P.O. Box 9101
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City/town
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Nijmegen
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Zip/Postcode
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6500 HB
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Country
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Netherlands
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Date applied
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22/11/2006
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Last edited
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27/11/2006
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Date ISRCTN assigned
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22/11/2006
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