Vitamin C as an Anti-cancer Drug
Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer
1 other identifier
interventional
31
1 country
1
Brief Summary
Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate cancer? Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the Unites States. When metastatic disease is present cure is no longer possible. The main treatment at this stage is castration, either surgical or medical, ending the patients testosterone production and causing a temporary regression in disease activity. Eventually, the cancer will progress, usually within 2 years from the castration, with a more aggressive course and a survival of 2-3 years. The current treatment option for the patients, who have undergone castration and have disease progression, is chemotherapy with only limited gains in quality of life and survival. This clinical study is a phase 2 study to evaluate the effects of high dose intravenous vitamin c in subjects with early castration resistant prostate cancer. Primary endpoint:
- Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions Secondary endpoints:
- Bone metastases changes after 12 to 20 weekly vitamin c infusions
- Changes in bone specific alkaline phosphates, oxidative DNA-damage, PINP, NTX after 12 to 20 weekly vitamin c infusions
- RNA-expression changes in prostatic tumor tissue after 12 to 20 weekly vitamin c infusions
- RNA-expression changes in lymphocytes after 12 to 20 weekly vitamin c infusions Tertiary endpoints:
- Pharmacokinetics of vitamin c in the elderly cancer patients Methods and material:
- 80 subjects are included (efficacy evaluation when 20 subjects have been evaluated for extension arm)
- Each subject receives a weekly infusion of 60 grams vitamin c (in the form of ascorbate) for 12 to 20 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2010
CompletedFirst Posted
Study publicly available on registry
March 4, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMarch 26, 2015
March 1, 2015
3.8 years
March 3, 2010
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PSA changes after 12-20 weeks of treatment
12, 20 and 26 weeks
Secondary Outcomes (5)
Bone metastases changes
12, 26 and 52 weeks
bALP changes
12, 20, 26 and 52 weeks
NTX changes
12, 20, 26 and 52 weeks
PINP changes
12, 20, 26 and 52 weeks
8-oxo-guanine changes
12 weeks
Study Arms (1)
Vitamin C treatment
EXPERIMENTALEach subjects receive 12 weeks of 1 weekly treatment with intravenous vitamin c. 5grams are given at week 1, 30 grams at week 2 and 60 grams at week 3-12. If eligibility criteria are met the subject may continue with 1 weekly vitamin c treatment of 60 grams at week 13-20.
Interventions
60grams of ascorbate given intravenous infusion in 1000ml sterile water.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Prior intended curative treatment of prostate cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copenhagen University Hospital at Herlevlead
- Rigshospitalet, Denmarkcollaborator
- University of Copenhagencollaborator
Study Sites (1)
Departmen of Urology, Copenhagen University Hospital at Herlev
Herlev, DK, 2730, Denmark
Related Publications (2)
Nielsen TK, Hojgaard M, Andersen JT, Jorgensen NR, Zerahn B, Kristensen B, Henriksen T, Lykkesfeldt J, Mikines KJ, Poulsen HE. Weekly ascorbic acid infusion in castration-resistant prostate cancer patients: a single-arm phase II trial. Transl Androl Urol. 2017 Jun;6(3):517-528. doi: 10.21037/tau.2017.04.42.
PMID: 28725594DERIVEDNielsen TK, Hojgaard M, Andersen JT, Poulsen HE, Lykkesfeldt J, Mikines KJ. Elimination of ascorbic acid after high-dose infusion in prostate cancer patients: a pharmacokinetic evaluation. Basic Clin Pharmacol Toxicol. 2015 Apr;116(4):343-8. doi: 10.1111/bcpt.12323. Epub 2014 Oct 7.
PMID: 25220574DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kari J Mikines, MD, DsMC
Copenhagen University Hospital at Herlev
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2010
First Posted
March 4, 2010
Study Start
November 1, 2010
Primary Completion
September 1, 2014
Study Completion
March 1, 2015
Last Updated
March 26, 2015
Record last verified: 2015-03