Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer
18 Years
N/A
Male
Prostatic Neoplasms
Trial Information
Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer
Vitamin C for palliative treatment:
Intravenous vitamin C has been used since the 1970's for terminally ill cancer patients
claiming big increases in survival time. The efficacy of the drug is questioned and no
randomized, controlled trial of Vitamin C's efficacy on cancer patients survival has been
made.
Recent results from in vitro and xenograft studies in mice has shown some promise for
vitamin c as a cytotoxic agent against cancer cells.
The following parameters are recorded for baseline:
- Biomarkers (PSA, bALP, NTX, PINP)
- Routine blood work (hgb, creatinine, p-vitamin c etc.)
- Radio nucleotide bone scintigraphy
- Prostate biopsies for later microarray (Affymetrix ST1.0)
- Urine samples 8-oxo-guanine(for oxidative DNA-damage measurements)
These parameters are repeated after treatment, usually after 12 to 26 weeks after the first
vitamin c infusion.
Inclusion Criteria:
- Castration resistant metastatic prostate cancer (bony or visceral metastases)
- Gleason sum > 6
- PSA > 10 ng/ml
- ECOG < 3
- Prior orchidectomy or LHRH antagonist/agonist treatment
- Must give informed content
Exclusion Criteria:
- Synchronous active cancer (skin cancer excluded)
- Prior chemotherapy
- History of oxalate renal stones
- Glucose-6-phosphate dehydrogenase deficiency
- Impaired renal function (creatinine > 200micromoles/L
- Haemochromatosis
- Cardiac disease (NYHA > 2, CSS > 2, recent AMI (less than 6 months)
- Recent major surgery (less than 4 weeks before inclusion and more than 2 days of
admittance time)
- Prior intended curative treatment of prostate cancer
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
PSA changes after 12-20 weeks of treatment
Outcome Time Frame:
12, 20 and 26 weeks
Safety Issue:
No
Principal Investigator
Kari J Mikines, MD, DsMC
Investigator Role:
Principal Investigator
Investigator Affiliation:
Copenhagen University Hospital at Herlev
Authority:
Denmark: The Regional Committee on Biomedical Research Ethics
Study ID:
2008-008692-33
NCT ID:
NCT01080352
Start Date:
November 2010
Completion Date:
March 2013
Related Keywords:
- Prostatic Neoplasms
- Prostate cancer
- palliative care
- antioxidants
- ascorbic acid
- rna expression
- Neoplasms
- Prostatic Neoplasms
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