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

Not Applicable

Completed

• Conditions: Prostate Cancer; Cancer; Prostate cancer

• Registration Number: ISRCTN47114653
• Lead Sponsor: Foundation for the Promotion of Urological Scientific Research (STIWU) (The Netherlands)

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/27330919 (added 24/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-22
• Study Completion: 2012-03-31
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSA progression after three years of study treatment.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Quality of life<br> 2. Performance Status<br> 3. Disease progression<br> 4. Survival<br> 5. Nature and number of Adverse Events (AEs)<br>