Weekly ascorbic acid infusion in castration-resistant prostate cancer patients: A single-arm phase II trial
Research output: Contribution to journal › Journal article › Research › peer-review
Background: Ascorbic acid (AA) has in vivo cytotoxic properties at concentrations that can only be achieved through intravenous (IV) administration in humans. Treatment with intravenous AA is widely and increasingly used in complementary medicine despite a lack of clinical evidence for the efficacy of this treatment.
Methods: This non-comparative, single-center, phase II trial included patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer (mCRPC) from an outpatient clinic to evaluate the efficacy and safety of IV AA therapy. Patients received weekly infusions of AA (week 1, 5 g; week 2, 30 g; and weeks 3-12, 60 g) followed by efficacy evaluation at 12 weeks. The primary endpoint for efficacy was a 50% reduction in the prostate-specific antigen (PSA) level. The secondary endpoints included changes in health-related quality of life (HRQoL), biomarkers of bone metabolism, inflammation and bone scans. Clinicaltrials.gov identifier: NCT01080352.
Results: Twenty-three patients were enrolled in this study, and 20 completed the efficacy evaluation at 12 weeks. The mean baseline PSA level was 43 μg/L. No patient achieved a 50% PSA reduction; instead, a median increase in PSA of 17 μg/L was recorded at week 12. Among the secondary endpoints, no signs of disease remission were observed. In total, 53 adverse events (AEs) were recorded. Eleven were graded as "serious". Three AEs were directly related to AA, and all of which were related to fluid load.
Conclusions: Infusion with 60 g of AA did not result in disease remission. This study does not support the use of intravenous AA outside clinical trials.
Original language | English |
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Journal | Translational Andrology and Urology |
Volume | 6 |
Issue number | 3 |
Pages (from-to) | 517-528 |
Number of pages | 12 |
ISSN | 2223-4683 |
DOIs | |
Publication status | Published - 2017 |
- Ascorbic acid (AA), Cancer, Complementary medicine, Prostatic neoplasms, Translational medical research
Research areas
Links
- http://europepmc.org/articles/pmc5503969?pdf=render
Accepted author manuscript
ID: 184416029