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