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

ISRCTN	ISRCTN47114653
DOI	https://doi.org/10.1186/ISRCTN47114653
Secondary identifying numbers	N/A

Submission date: 22/11/2006
Registration date: 22/11/2006
Last edited: 24/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr W J de Bruijn
Scientific

CuraTrial
P.O. Box 30016
Arnhem
6803 AA
Netherlands

Phone	+31 (0)26 3890677
Email	w.debruijn@curatrial.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Study acronym	AVOCAT study
Study objectives	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(s)	Approval received from the Committee Human Research region Arnhem-Nijmegen (The Netherlands)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/03/2006
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	324
Total final enrolment	150
Key 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
Key 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
Date of first enrolment	01/03/2006
Date of final enrolment	31/03/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

CuraTrial

Arnhem
6803 AA
Netherlands

Sponsor information

Foundation for the Promotion of Urological Scientific Research (STIWU) (The Netherlands)
Research organisation

P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Funders

Funder type

Research organisation

Foundation for the Promotion of Urological Scientific Research (Stichting ter bevordering van het Wetenschappelijk Urologisch onderzoek [STIWU]) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/05/2016	24/01/2020	Yes	No

Editorial Notes

24/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.