Evaluation of cytotoxicity and genetic changes of high dose vitamin C infusions in castration resistant metastatic human prostate cancer. - Vitamin C as an anti-cancer drug

Department of Urology, Herlev Hospital0 个研究点开始时间: 2009年12月21日最近更新: 2014年12月1日

试验速览

暂无简介。

•Gender: male
•Age > 18 years
•Biopsy verified PCa
•Gleason sum >6
•PSA >10 ng/ml (no PSA-negative cancers)
•No predominant neuro-endocrine differentiation
•Metastatic PCa defined as extra nodal (visceral) metastasis and/or bone lesions on radionucleotide bone scan.
•Hormone refractory disease defined as at least 2 increases in PSA with at least 10% increases a least 1 week apart within the last 6 months.
•Se-testosterone must be at castrate level
•The patients must have received prior hormonal ablation treatment consisting of either orchiectomy or LHRH-antagonists/agonists with the optional addition of non-steroidal anti-androgens(bicalutamid).
•Any LHRH agonist or antagonist treatment must be continued during the protocol.
•Discontinuation of non-steroidal anti-androgen must be attempted prior to enrolment.
•ECOG performance status 0-2
•Negative test-screen regarding G-6-P DH deficiency.
•Normal to near normal renal function (se-creatinium <200µM and no history of major impaired renal function)
•Bisphophonate and prednisone therapy can be continued during the project
•External beam radiation of extraprostatic metastases allowed
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Adverse and intolerable side effects to infusions (see side effects…” paragraph)
•Deteriorating physical condition not allowing for outpatient infusions
•Physician or patient opting for chemotherapy or other interventional therapy
•Synchronous cancers (non-melanoma skin cancer excluded)
•No chemotherapy for PCa allowed during the treatment period (week 1-12 (20))
•Allergies to vitamin C or additives in project medications
•History of oxalate kidney stone
•History of hemochromatosis
•Major surgery for the past 4 weeks (def.: surgical procedures requiring >2 days of admittance)
•Active cardiac disease (CCS >2, NYHA >2), myocardial infarction for the past 6 months
•Participation in clinical trials involving administration of any pharmaceutical drugs whilst receiving the VC infusions.

发起方

Department of Urology, Herlev Hospital