An open, single dose, antitumor effect study of 2-hydroxyflutamide as a controlled release product (Liproca® Depot), injected into the prostate in patients with localized prostate cancer.

IDDS AB0 个研究点目标入组 28 人开始时间: 2011年3月21日最近更新: 2016年4月11日

试验速览

暂无简介。

•1) Age = 50 years, = 75 years
•2) Histologically confirmed localized (stage T1c, T2a-T2c) prostate cancer that is judged relevant for prostatectomy.
•3) PSA value < 20 ng/ml within 6 weeks before enrolment.
•4) Gleason score = 3+4 at diagnostic biopsy (or preferably with more precise method for judging the localization of the primary tumour focus (foci).
•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 bacteriuria.
•8) Patient must have ability to cope with the study procedures and to return to scheduled visits including follow up visit.
•9) Patients that has been scheduled for prostatectomy
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 28
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

•1) On-going or previous hormone therapy for prostate cancer.
•2) On-going or previous therapy within 12 month of finasteride or dutasteride.
•3) On-going or previous invasive therapy for benign prostate hyperplasia (TURP, TUMT).
•4) Use of pace maker, other electronic devices or metallic hip prosthesis device
•5) Symptoms or signs of acute prostatitis.
•6) Symptoms or signs of ulceric proctitis
•7) Severe micturation symptoms (I-PSS >17)
•8) On-going therapy with anticoagulant (e.g Warfarin. Other anticoagulant should be withdrawn 1 week before injection).
•9) Concomitant systemic treatment with corticosteroids, or immune modulating agents.
•10) Known immunosuppressive disease (e.g. HIV, diabetes).
•11) 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