Condition category
Cancer
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
27/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.curatrial.com

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

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 measures

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

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

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

Sponsor information

Organisation

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

Sponsor details

P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes