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Clinical Trials/ISRCTN47114653
ISRCTN47114653
Completed
未知

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

Foundation for the Promotion of Urological Scientific Research (STIWU) (The Netherlands)0 sites150 target enrollmentNovember 22, 2006
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ConditionsProstate CancerCancerProstate cancer

Overview

Phase
未知
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Foundation for the Promotion of Urological Scientific Research (STIWU) (The Netherlands)
Enrollment
150
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
who.int
Start Date
November 22, 2006
End Date
March 31, 2012
Last Updated
6 years ago
Study Type
Interventional
Sex
Male

Investigators

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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