Adenoma of the prostate, elevated serum-PSA value
Conditions
Interventions
Product Name: Finasterid
Pharmaceutical Form: Tablet
INN or Proposed INN: Finasterid
Concentration unit: mg milligram(s)
Concentration number: 5-
Sponsors
Urologische Partnerschaft
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - patients with elevated serum-PSA value - Negative biopsy (min. sixfold), max. 2-12 months prior to inclusion - Existence of enlargement of the prostate (>25 ml) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - former or current use of 5-alpha reductase inhibitors - proof of prostate cancer - acute prostatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The relationship between Finasterid-dependent PSA decrease and the diagnosis of prostate cancer will be investigated in patients with BPH and elevated;Secondary Objective: - Proof of prostate cancer in patients at risk of having prostate cancer after previous negative biobsy and the treatment with 5 mg Finasterid. - Distribution of tumor grades (Gleason) tumors diagnosed. - Determination of the BPH-symptome score using IPSS questionare before and after 6 month of treatment with Finasterid 5 mg/d - Volume of the prostate before and after 6 months treatment with Finasterid 5 mg/d - Investigation of new markers (cPSA, PCA3) in predicting prostate cancer in patients with elevated serum PSA;Primary end point(s): Decrease of serum-PSA value after 6 months of treatment with Finasterid 5 mg/d | — |
Countries
Germany
Outcome results
None listed