TY - JOUR

T1 - Weekly ascorbic acid infusion in castration-resistant prostate cancer patients

T2 - A single-arm phase II trial

AU - Nielsen, Torben K.

AU - Højgaard, Martin

AU - Andersen, Jon T.

AU - Jørgensen, Niklas Rye

AU - Zerahn, Bo

AU - Kristensen, Bent

AU - Henriksen, Trine

AU - Lykkesfeldt, Jens

AU - Mikines, Kári J.

AU - Poulsen, Henrik E.

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

KW - Ascorbic acid (AA)

KW - Cancer

KW - Complementary medicine

KW - Prostatic neoplasms

KW - Translational medical research

U2 - 10.21037/tau.2017.04.42

DO - 10.21037/tau.2017.04.42

M3 - Journal article

C2 - 28725594

AN - SCOPUS:85021045570

VL - 6

SP - 517

EP - 528

JO - Translational Andrology and Urology

JF - Translational Andrology and Urology

SN - 2223-4683

IS - 3

ER -