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 - Liproca® Depot

IDDS AB0 个研究点目标入组 0 人开始时间: 2009年3月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Signed Informed Consent must be obtained before any study specific procedures takes place.
•1.Age = 45 years
•2.Histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal 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.No bacturia (test by dipstick).
•8.Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
•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

•1.Previous or ongoing hormone therapy for prostate cancer.
•2.Ongoing or previous therapy (within 3 month) of finasteride or dutasteride.
•3.Ongoing or previous invasive therapy for benign prostata hyperplasia (TURP, TUMT).
•4.Symptoms or signs of acute prostatitis or other local inflammation.
•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, 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 treatment.

发起方

IDDS AB