The effect of high dose intravenous weekly vitamin c infusion in castration resistant human prostate cancer MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps
Conditions
Interventions
Trade Name: Bio-C-Vitamin "Pharma Nord" syreneutral
Product Name: Bio-C-Vitamin "Pharma Nord" syreneutral
Pharmaceutical Form: Tablet
INN or Proposed INN: ASCORBIC ACID
CAS Number: 50817
Concentration
Sponsors
Department of Urology, Herlev Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Gender: male Age > 18 years Biopsy verified PCa Gleason sum >6 PSA >10 ng/ml (no PSA-negative cancers) No predominant neuro-endocrine differentiation Metastatic PCa defined as extra nodal (visceral) metastasis and/or bone lesions on radionucleotide bone scan. Hormone refractory disease defined as at least 2 increases in PSA with at least 10% increases a least 1 week apart within the last 6 months. Se-testosterone must be at castrate level The patients must have received prior hormonal ablation treatment consisting of either orchiectomy or LHRH-antagonists/agonists with the optional addition of non-steroidal anti-androgens(bicalutamid). Any LHRH agonist or antagonist treatment must be continued during the protocol. Discontinuation of non-steroidal anti-androgen must be attempted prior to enrolment. ECOG performance status 0-2 Negative test-screen regarding G-6-P DH deficiency. Normal to near normal renal function (se-creatinium =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Adverse and intolerable side effects to infusions (see “side effects…” paragraph) Deteriorating physical condition not allowing for outpatient infusions Physician or patient opting for chemotherapy or other interventional therapy Synchronous cancers (non-melanoma skin cancer excluded) No chemotherapy for PCa allowed during the treatment period (week 1-12 (20)) Allergies to vitamin C or additives in project medications History of oxalate kidney stone History of hemochromatosis Major surgery for the past 4 weeks (def.: surgical procedures requiring >2 days of admittance) Active cardiac disease (CCS >2, NYHA >2), myocardial infarction for the past 6 months Participation in clinical trials involving administration of any pharmaceutical drugs whilst receiving the VC infusions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate (Prostate specific antigene) PSA response to high dose, weekly intraveneous vitamin C(VC) treatment after 12, 20, 25 and 52 weeks in subjects with castration resistant prostate cancer.;Secondary Objective: Median survival in subjects vs. patients receiving Docetaxel (def. survival from time of hormone refractory disease until death) ECOG performance status before treatment and at 12, 20, 26 and 52 weeks EORCT Core and P25 changes at week 12 Extent of osseous metastasis using bone scan before treatment and at 12, 26 and 52 weeks Alkaline phosphatase changes before treatment and at 12, 20, 26 and 52 weeks se-Ca2+ changes before treatment and at 12, 20, 26 and 52 weeks Whole genome gene expression changes before treatment and at 12 and possibly 20 weeks Changes in oxidative DNA-damage before treatment and at 12 and possibly 20 weeks ;Primary end point(s): PSA response to treatment with IMP;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A: PSA response to treatment with IMP (8 week extension arm) B: Bone metastases changes C: bALP changes u-NTX changes PINP changes 8-oxo-guanine changes;Timepoint(s) of evaluation of this end point: A: 20 weeks B: 12,26 and 52 weeks C: 12,20,26 and 52 weeks | — |
Countries
Denmark
Contacts
Public ContactKari J. Mikines
Department of Urology, Herlev Hospital
Outcome results
None listed