Prostate cancer MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Age: 40 to 85 years old - Language spoken: Finnish - Diagnosis: Histologically confirmed adenocarcinoma of prostate - Adequate histological sampling consisting of at least 3 biopsy samples from each lobe - No previous surgical, radiation or endocrine treatment for prostate carcinoma - Clinical stage: - T1c-T4N0-2M0-1 (Study APhase 1) - Serum creatinine = 1,5 x ULN - Mental status: Patients must be able to understand the meaning of the study - Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff 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 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: - Infections: Patient must not have an uncontrolled serious infection - Contraindications for MRI (cardiac pacemaker, intracranial clips etc) - Prior usage of 5-ARI medication in past 12 months - Patient preference for active surveillance as a method of prostate cancer management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the time course effect of GnRh-antagonist on prostate cancer PSMA expression;Secondary Objective: To determine the time course of testosterone level decline in relation to PSMA expression after initiation of GnRh-antagonist therapy;Primary end point(s): | — |
Countries
Finland
Contacts
Public ContactTurku University Hospital
Turku University Hospital
Outcome results
None listed