PMID- 28725594
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2223-4691 (Print)
IS  - 2223-4691 (Electronic)
IS  - 2223-4683 (Linking)
VI  - 6
IP  - 3
DP  - 2017 Jun
TI  - Weekly ascorbic acid infusion in castration-resistant prostate cancer patients: a 
      single-arm phase II trial.
PG  - 517-528
LID - 10.21037/tau.2017.04.42 [doi]
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-naive, 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 microg/L. No patient achieved a 50% PSA reduction; instead, a median 
      increase in PSA of 17 microg/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.
FAU - Nielsen, Torben K
AU  - Nielsen TK
AD  - Department of Urology, Copenhagen University Hospital, Herlev, Denmark.
AD  - Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, 
      Denmark.
FAU - Hojgaard, Martin
AU  - Hojgaard M
AD  - Department of Urology, Copenhagen University Hospital, Herlev, Denmark.
FAU - Andersen, Jon T
AU  - Andersen JT
AD  - Laboratory of Clinical Pharmacology, Copenhagen University Hospital, 
      Rigshospitalet, Copenhagen, Denmark.
AD  - Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg, 
      Frederiksberg, Denmark.
FAU - Jorgensen, Niklas Rye
AU  - Jorgensen NR
AD  - Department of Clinical Biochemistry, Copenhagen University Hospital, 
      Rigshospitalet, Denmark.
AD  - Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
FAU - Zerahn, Bo
AU  - Zerahn B
AD  - Department of Clinical Physiology and Nuclear Medicine, Copenhagen University 
      Hospital, Herlev, Denmark.
FAU - Kristensen, Bent
AU  - Kristensen B
AD  - Department of Clinical Physiology and Nuclear Medicine, Copenhagen University 
      Hospital, Herlev, Denmark.
FAU - Henriksen, Trine
AU  - Henriksen T
AD  - Laboratory of Clinical Pharmacology, Copenhagen University Hospital, 
      Rigshospitalet, Copenhagen, Denmark.
AD  - Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg, 
      Frederiksberg, Denmark.
FAU - Lykkesfeldt, Jens
AU  - Lykkesfeldt J
AD  - Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, 
      Denmark.
FAU - Mikines, Kari J
AU  - Mikines KJ
AD  - Department of Urology, Copenhagen University Hospital, Herlev, Denmark.
AD  - Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, 
      Denmark.
FAU - Poulsen, Henrik E
AU  - Poulsen HE
AD  - Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, 
      Denmark.
AD  - Laboratory of Clinical Pharmacology, Copenhagen University Hospital, 
      Rigshospitalet, Copenhagen, Denmark.
AD  - Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg, 
      Frederiksberg, Denmark.
LA  - eng
SI  - ClinicalTrials.gov/NCT01080352
PT  - Journal Article
PL  - China
TA  - Transl Androl Urol
JT  - Translational andrology and urology
JID - 101581119
PMC - PMC5503969
OTO - NOTNLM
OT  - Prostatic neoplasms
OT  - ascorbic acid (AA)
OT  - cancer
OT  - complementary medicine
OT  - translational medical research
COIS- Conflicts of Interest: The authors have no conflicts of interest to declare.
EDAT- 2017/07/21 06:00
MHDA- 2017/07/21 06:01
PMCR- 2017/06/01
CRDT- 2017/07/21 06:00
PHST- 2017/07/21 06:00 [entrez]
PHST- 2017/07/21 06:00 [pubmed]
PHST- 2017/07/21 06:01 [medline]
PHST- 2017/06/01 00:00 [pmc-release]
AID - tau-06-03-517 [pii]
AID - 10.21037/tau.2017.04.42 [doi]
PST - ppublish
SO  - Transl Androl Urol. 2017 Jun;6(3):517-528. doi: 10.21037/tau.2017.04.42.