Prostatic NeoplasmsPhase 2NCT01080352
Vitamin C as an Anti-cancer Drug
A Phase 2 study testing Ascorbic Acid (Vitamin C) in people with Prostatic Neoplasms, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate cancer? Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the Unites States. When metastatic disease is present cure is no longer possible. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Ascorbic Acid (Vitamin C)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Castration resistant metastatic prostate cancer (bony or visceral metastases)
- Gleason sum > 6
- PSA > 10 ng/ml
- ECOG < 3
- Prior orchidectomy or LHRH antagonist/agonist treatment
- Must give informed content
Who cannot join
- Synchronous active cancer (skin cancer excluded)
- Prior chemotherapy
- History of oxalate renal stones
- Glucose-6-phosphate dehydrogenase deficiency
- Impaired renal function (creatinine > 200micromoles/L
- Haemochromatosis
Show all 9Show fewer
- Cardiac disease (NYHA > 2, CSS > 2, recent AMI (less than 6 months)
- Recent major surgery (less than 4 weeks before inclusion and more than 2 days of admittance time)
- Prior intended curative treatment of prostate cancer
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Departmen of Urology, Copenhagen University Hospital at Herlev
Herlev, DK, 2730
About this study
Official title: Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer
Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate cancer?
Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the Unites States. When metastatic disease is present cure is no longer possible. The main treatment at this stage is castration, either surgical or medical, ending the patients testosterone production and causing a temporary regression in disease activity.
Read more
Eventually, the cancer will progress, usually within 2 years from the castration, with a more aggressive course and a survival of 2-3 years.
The current treatment option for the patients, who have undergone castration and have disease progression, is chemotherapy with only limited gains in quality of life and survival.
This clinical study is a phase 2 study to evaluate the effects of high dose intravenous vitamin c in subjects with early castration resistant prostate cancer.
Primary endpoint:
- Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions
Secondary endpoints:
- Bone metastases changes after 12 to 20 weekly vitamin c infusions
- Changes in bone specific alkaline phosphates, oxidative DNA-damage, PINP, NTX after 12 to 20 weekly vitamin c infusions
- RNA-expression changes in prostatic tumor tissue after 12 to 20 weekly vitamin c infusions
- RNA-expression changes in lymphocytes after 12 to 20 weekly vitamin c infusions
Tertiary endpoints:
- Pharmacokinetics of vitamin c in the elderly cancer patients
Methods and material:
- 80 subjects are included (efficacy evaluation when 20 subjects have been evaluated for extension arm)
- Each subject receives a weekly infusion of 60 grams vitamin c (in the form of ascorbate) for 12 to 20 weeks
Read the detailed description
Vitamin C for palliative treatment:
Intravenous vitamin C has been used since the 1970's for terminally ill cancer patients claiming big increases in survival time. The efficacy of the drug is questioned and no randomized, controlled trial of Vitamin C's efficacy on cancer patients survival has been made.
Recent results from in vitro and xenograft studies in mice has shown some promise for vitamin c as a cytotoxic agent against cancer cells.
The following parameters are recorded for baseline:
- Biomarkers (PSA, bALP, NTX, PINP)
- Routine blood work (hgb, creatinine, p-vitamin c etc.)
- Radio nucleotide bone scintigraphy
- Prostate biopsies for later microarray (Affymetrix ST1.0)
- Urine samples 8-oxo-guanine(for oxidative DNA-damage measurements)
These parameters are repeated after treatment, usually after 12 to 26 weeks after the first vitamin c infusion.
- Conditions
- Prostatic Neoplasms
- Being tested
- Ascorbic Acid (Vitamin C)
- Keywords
- Prostate cancer, palliative care, antioxidants, ascorbic acid, rna expression
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic Acid (Vitamin C)Drug
60grams of ascorbate given intravenous infusion in 1000ml sterile water.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C treatment | Experimental | Each subjects receive 12 weeks of 1 weekly treatment with intravenous vitamin c.
5grams are given at week 1, 30 grams at week 2 and 60 grams at week 3-12. If eligibility criteria are met the subject may continue with 1 weekly vitamin c treatment of 60 grams at week 13-20. Receives: Drug: Ascorbic Acid (Vitamin C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA changes after 12-20 weeks of treatment
Measured: 12, 20 and 26 weeks
Secondary outcomes (5)
Bone metastases changes
Measured: 12, 26 and 52 weeks
bALP changes
Measured: 12, 20, 26 and 52 weeks
NTX changes
Measured: 12, 20, 26 and 52 weeks
PINP changes
Measured: 12, 20, 26 and 52 weeks
8-oxo-guanine changes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kari J Mikines, MD, DsMC, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080352
- Sponsor's protocol ID
- 2008-008692-33
- Other IDs
- 2008
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2010
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen TK, Hojgaard M, Andersen JT, Jorgensen NR, Zerahn B, Kristensen B, Henriksen T, Lykkesfeldt J, Mikines KJ, Poulsen HE. Weekly ascorbic acid infusion in castration-resistant prostate cancer patients: a single-arm phase II trial. Transl Androl Urol. 2017 Jun;6(3):517-528. doi: 10.21037/tau.2017.04.42.
PubMed 28725594Nielsen TK, Hojgaard M, Andersen JT, Poulsen HE, Lykkesfeldt J, Mikines KJ. Elimination of ascorbic acid after high-dose infusion in prostate cancer patients: a pharmacokinetic evaluation. Basic Clin Pharmacol Toxicol. 2015 Apr;116(4):343-8. doi: 10.1111/bcpt.12323. Epub 2014 Oct 7.
PubMed 25220574
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cytotoxicity and Genetic Changes of High Dose Vitamin C Infusions in Castration Resistant Metastatic Human Prostate Cancer
- ClinicalTrials.gov ID
- NCT01080352
- Acronym / sponsor ID
- 2008-008692-33
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate cancer, palliative care, antioxidants, ascorbic acid, rna expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University of Copenhagen
- Study start
- Nov 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can high dose, intravenous Vitamin C prolong life for patients with metastatic prostate cancer?
Prostate cancer is the most common cancer (excluding skin cancer) in men in Denmark and the Unites States. When metastatic disease is present cure is no longer possible. The main treatment at this stage is castration, either surgical or medical, ending the patients testosterone production and causing a temporary regression in disease activity.
Eventually, the cancer will progress, usually within 2 years from the castration, with a more aggressive course and a survival of 2-3 years.
The current treatment option for the patients, who have undergone castration and have disease progression, is chemotherapy with only limited gains in quality of life and survival.
This clinical study is a phase 2 study to evaluate the effects of high dose intravenous vitamin c in subjects with early castration resistant prostate cancer.
Primary endpoint:
- Prostate specific antigen (PSA) changes after 12 to 20 weekly vitamin c infusions
Secondary endpoints:
- Bone metastases changes after 12 to 20 weekly vitamin c infusions
- Changes in bone specific alkaline phosphates, oxidative DNA-damage, PINP, NTX after 12 to 20 weekly vitamin c infusions
- RNA-expression changes in prostatic tumor tissue after 12 to 20 weekly vitamin c infusions
- RNA-expression changes in lymphocytes after 12 to 20 weekly vitamin c infusions
Tertiary endpoints:
- Pharmacokinetics of vitamin c in the elderly cancer patients
Methods and material:
- 80 subjects are included (efficacy evaluation when 20 subjects have been evaluated for extension arm)
- Each subject receives a weekly infusion of 60 grams vitamin c (in the form of ascorbate) for 12 to 20 weeks
Detailed description
Vitamin C for palliative treatment:
Intravenous vitamin C has been used since the 1970's for terminally ill cancer patients claiming big increases in survival time. The efficacy of the drug is questioned and no randomized, controlled trial of Vitamin C's efficacy on cancer patients survival has been made.
Recent results from in vitro and xenograft studies in mice has shown some promise for vitamin c as a cytotoxic agent against cancer cells.
The following parameters are recorded for baseline:
- Biomarkers (PSA, bALP, NTX, PINP)
- Routine blood work (hgb, creatinine, p-vitamin c etc.)
- Radio nucleotide bone scintigraphy
- Prostate biopsies for later microarray (Affymetrix ST1.0)
- Urine samples 8-oxo-guanine(for oxidative DNA-damage measurements)
These parameters are repeated after treatment, usually after 12 to 26 weeks after the first vitamin c infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin C treatment | Experimental | Drug: Ascorbic Acid (Vitamin C)Each subjects receive 12 weeks of 1 weekly treatment with intravenous vitamin c. 5grams are given at week 1, 30 grams at week 2 and 60 grams at week 3-12. If eligibility criteria are met the subject may continue with 1 weekly vitamin c treatment of 60 grams at week 13-20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Castration resistant metastatic prostate cancer (bony or visceral metastases)
- Gleason sum > 6
- PSA > 10 ng/ml
- ECOG < 3
- Prior orchidectomy or LHRH antagonist/agonist treatment
Key exclusion criteria (9 listed)
- Synchronous active cancer (skin cancer excluded)
- Prior chemotherapy
- History of oxalate renal stones
- Glucose-6-phosphate dehydrogenase deficiency
- Impaired renal function (creatinine > 200micromoles/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic Acid (Vitamin C)60grams of ascorbate given intravenous infusion in 1000ml sterile water. | Drug | Vitamin C treatment |
Primary outcome
PSA changes after 12-20 weeks of treatment
Time frame: 12, 20 and 26 weeks
5 secondary outcomes
Bone metastases changes
Time frame: 12, 26 and 52 weeks
bALP changes
Time frame: 12, 20, 26 and 52 weeks
NTX changes
Time frame: 12, 20, 26 and 52 weeks
PINP changes
Time frame: 12, 20, 26 and 52 weeks
8-oxo-guanine changes
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Derived from this study: PubMed 28725594Nielsen TK, Hojgaard M, Andersen JT, Jorgensen NR, Zerahn B, Kristensen B, Henriksen T, Lykkesfeldt J, Mikines KJ, Poulsen HE. Weekly ascorbic acid infusion in castration-resistant prostate cancer patients: a single-arm phase II trial. Transl Androl Urol. 2017 Jun;6(3):517-528. doi: 10.21037/tau.2017.04.42.
- Derived from this study: PubMed 25220574Nielsen TK, Hojgaard M, Andersen JT, Poulsen HE, Lykkesfeldt J, Mikines KJ. Elimination of ascorbic acid after high-dose infusion in prostate cancer patients: a pharmacokinetic evaluation. Basic Clin Pharmacol Toxicol. 2015 Apr;116(4):343-8. doi: 10.1111/bcpt.12323. Epub 2014 Oct 7.
- Participant information (in Danish)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari J Mikines, MD, DsMC principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic Acid (Vitamin C) in people with Prostatic Neoplasms, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA changes after 12-20 weeks of treatment (time frame: 12, 20 and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080352, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.