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 sitesDecember 21, 2009

Overview

No summary available.

Registry

who.int

Start Date

December 21, 2009

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Department of Urology, Herlev Hospital

•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).

•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