An Open, Single and Multiple Dose, Efficacy and Safety Proof of Principle Study of Liproca Depot, a Controlled Release Formulation of 2-hydroxyflutamide, Injected Into the Prostate in Patients With Localized Prostate Cancer
1. Age ≥ 45years
2. Histologically confirmed localized prostate cancer (T1-T2), predominantly in one side
of the peripheral zone, verified by biopsy.
3. PSA value < 20 ng/ml within 6 weeks before enrolment.
4. Gleason score ≤ 3+4 at diagnostic biopsy
5. Adequate renal function: Creatinine < 1.5 times upper limit of normal.
6. Adequate hepatic function: ASAT, ALAT and ALP < 1.5 times upper limit of normal.
7. Negative dipstick for bacturia.
8. Patient must have ability to cope with the study procedures and to return to
scheduled visits including follow up visit.
1. Previous or ongoing hormone therapy for prostate cancer.
2. Ongoing or previous therapy (within3 month) of finasteride or dutasteride.
3. Ongoing or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
4. Symptoms or signs of acute prostatitis.
5. Symptoms or signs of ulceric proctitis
6. Severe micturation symptoms (I-PSS >17)
7. Concomitant systemic treatment with corticosteroids, or immunomodulating agents.
8. Known immunosuppressive disease (e.g. HIV, insulin dependent diabetes).
9. Simultaneous participation in any other study involving not market authorized drugs
or having participated in a study within the last 12 months prior to start of study