Vitamin C as an anti-cancer drug

• Conditions: The effect of high dose intravenous weekly vitamin c infusion in castration resistant human prostate cancer; MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-008692-33-DK
• Lead Sponsor: Department of Urology, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-21
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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 <200µM and no history of major impaired renal function)
Bisphophonate and prednisone therapy can be continued during the project
External beam radiation of extraprostatic metastases allowed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>ECOG performance status before treatment and at 12, 20, 26 and 52 weeks<br>EORCT Core and P25 changes at week 12<br>Extent of osseous metastasis using bone scan before treatment and at 12, 26 and 52 weeks<br>Alkaline phosphatase changes before treatment and at 12, 20, 26 and 52 weeks<br>se-Ca2+ changes before treatment and at 12, 20, 26 and 52 weeks<br>Whole genome gene expression changes before treatment and at 12 and possibly 20 weeks<br>Changes in oxidative DNA-damage before treatment and at 12 and possibly 20 weeks<br>;Primary end point(s): PSA response to treatment with IMP;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): A: <br>PSA response to treatment with IMP (8 week extension arm)<br><br>B:<br>Bone metastases changes <br><br>C:<br>bALP changes<br>u-NTX changes <br>PINP changes<br>8-oxo-guanine changes;Timepoint(s) of evaluation of this end point: A:<br>20 weeks<br><br>B:<br>12,26 and 52 weeks<br><br>C:<br>12,20,26 and 52 weeks