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Vitamin C as an Anti-cancer Drug

NCT01080352 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-03-26

No results posted yet for this study

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

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Ascorbic Acid (Vitamin C)

60grams of ascorbate given intravenous infusion in 1000ml sterile water.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Copenhagen University Hospital at Herlev

    lead OTHER

Principal Investigators

  • Kari J Mikines, MD, DsMC · Copenhagen University Hospital at Herlev

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-09-30
Completion
2015-03-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01080352 on ClinicalTrials.gov