Contact information
Type
Scientific
Primary contact
Dr W J de Bruijn
ORCID ID
Contact details
CuraTrial
P.O. Box 30016
Arnhem
6803 AA
Netherlands
+31 (0)26 3890677
w.debruijn@curatrial.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
AVOCAT study
Study hypothesis
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.
Ethics approval
Approval received from the Committee Human Research region Arnhem-Nijmegen (The Netherlands)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Prostate Cancer
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Bicalutamide and dutasteride
Primary outcome measure
PSA progression after three years of study treatment.
Secondary outcome measures
1. Quality of life
2. Performance Status
3. Disease progression
4. Survival
5. Nature and number of Adverse Events (AEs)
Overall trial start date
01/03/2006
Overall trial end date
31/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
324
Total final enrolment
150
Participant exclusion criteria
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
Recruitment start date
01/03/2006
Recruitment end date
31/03/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
CuraTrial
Arnhem
6803 AA
Netherlands
Funders
Funder type
Research organisation
Funder name
Foundation for the Promotion of Urological Scientific Research (Stichting ter bevordering van het Wetenschappelijk Urologisch onderzoek [STIWU]) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/27330919 (added 24/01/2020)