Impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy – lipid metabolism as a novel biomarker to predict prostate cancer progression – phase 3, double-blind randomized clinical trial

Pirkanmaan sairaanhoitopiiri0 个研究点目标入组 400 人开始时间: 2023年2月8日最近更新: 2023年10月30日

试验速览

暂无简介。

•1. Histopathologically confirmed metastatic adenocarcinoma of the prostate (radiologically confirmed bone or soft tissue metastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelvic lymph nodes) for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated no longer than 3 months before recruitment
•oprevious prostatectomy and radiation therapy allowed
•2. The participant is willing to participate and signs informed consent
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•- Androgen deprivation initiated as temporary neoadjuvant treatment
•- Statin use at the time of recruitment or within 6 months of it
•- Previous adverse effects during statin therapy
•- Familial hypercholesterolemia or very high total cholesterol (9.3 mmol/l or above)
•- Clinically significant renal insufficiency (serum creatinine above 170 µmol/l) or liver insufficiency (serum alanine aminotransferase more than 2x above the upper limit of normal range)
•- Use of drugs that may interact with statins (St John’s Wort, HIV protease inhibitors, ciclosporin, macrolide antibiotics, fucidic acid, phenytoin, carbamazepine, dronedarone or oral antifungal medication).

发起方

Pirkanmaan sairaanhoitopiiri