Prostate CancerPhase 2NCT00524680

Vitamin D in Treating Patients With Prostate Cancer

A Phase 2 study testing cholecalciferol in people with Prostate Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RATIONALE: Vitamin D may be effective in treating patients with prostate cancer. PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer. Read more about this study

Who is it for?: Ages 18 to 120 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: cholecalciferol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 148 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Mar 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 120 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

ECOG performance status 0-2
Creatinine ≤ 2.0 mg/dL
Corrected serum calcium ≤ 10.5 mg/dL

Who cannot join

History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
Hypersensitivity to cholecalciferol or one of its components
PRIOR CONCURRENT THERAPY:
No other concurrent vitamin D supplementation

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263-0001

Other trials in United States

About this study

Official title: Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients

RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.

Read the detailed description

OBJECTIVES:

Primary

To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol (vitamin D3) supplementation at four different oral doses in patients with prostate cancer.

Secondary

To examine the pattern of response of parathormone (PTH) following vitamin D3 supplementation in these patients.
To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

Tertiary

To track occurrence of infections, deep vein thrombosis, vascular events, and falls in these patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
Arm II: Patients receive 6,000 IU of vitamin D3 once daily.
Arm III: Patients receive 8,000 IU of vitamin D3 once daily.
Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms continues for 6 months in the absence of disease progression or unacceptable toxicity.

Conditions: Prostate Cancer
Being tested: cholecalciferol
Keywords: adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cholecalciferolDietary supplement
Given orally

Study groups in NCT00524680
Study group	Role	What they receive
Arm I	Experimental	Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily. Receives: Dietary Supplement: cholecalciferol
Arm II	Experimental	Patients receive 6,000 IU of vitamin D3 once daily. Receives: Dietary Supplement: cholecalciferol
Arm III	Experimental	Patients receive 8,000 IU of vitamin D3 once daily. Receives: Dietary Supplement: cholecalciferol
Arm IV	Experimental	Patients receive 10,000 IU of vitamin D3 once daily. Receives: Dietary Supplement: cholecalciferol

What is being measured

The primary outcome is the main question the study is designed to answer.

Pattern of Response of Serum 25(OH) D3 Levels
Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
Measured: Baseline, at 1, 3, 6 months

Secondary outcomes (3)

Pattern of Response of Parathormone
Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
Measured: Baseline, at 1, 3, 6 months
Toxicity
Number of treated patients that had serious adverse events.
Measured: Baseline, at 1, 3 and 6 months
Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls
Measured: Baseline, at 1, 3 ,6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Mar 2013

First posted3 Sep 2007 (estimated)
Study startJun 2007
Primary completionMay 2011
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00524680
Sponsor's protocol ID: CDR0000562742
Other IDs: I 95406
Status last verified: Sep 2015
First submitted: 31 Aug 2007
Last updated: 2 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Serum 25(OH) D3 Level Variability in Response to Different Doses of Oral Vitamin D Supplementation in Prostate Cancer Patients
ClinicalTrials.gov ID: NCT00524680
Acronym / sponsor ID: CDR0000562742
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Study start: Jun 2007
Primary completion: May 2011 (actual)
Study completion: Mar 2013 (actual)
First posted: 3 Sep 2007 (estimated)
Results: Posted 2 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.

Detailed description

OBJECTIVES:

Primary

To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol (vitamin D3) supplementation at four different oral doses in patients with prostate cancer.

Secondary

To examine the pattern of response of parathormone (PTH) following vitamin D3 supplementation in these patients.
To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

Tertiary

To track occurrence of infections, deep vein thrombosis, vascular events, and falls in these patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
Arm II: Patients receive 6,000 IU of vitamin D3 once daily.
Arm III: Patients receive 8,000 IU of vitamin D3 once daily.
Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms continues for 6 months in the absence of disease progression or unacceptable toxicity.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm I	Experimental	Dietary Supplement: cholecalciferolPatients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
Arm II	Experimental	Dietary Supplement: cholecalciferolPatients receive 6,000 IU of vitamin D3 once daily.
Arm III	Experimental	Dietary Supplement: cholecalciferolPatients receive 8,000 IU of vitamin D3 once daily.
Arm IV	Experimental	Dietary Supplement: cholecalciferolPatients receive 10,000 IU of vitamin D3 once daily.

Who may qualify

Ages: 18 to 120 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

ECOG performance status 0-2
Creatinine ≤ 2.0 mg/dL
Corrected serum calcium ≤ 10.5 mg/dL

Key exclusion criteria (4 listed)

History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
Hypersensitivity to cholecalciferol or one of its components
No other concurrent vitamin D supplementation

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
cholecalciferolGiven orally	Dietary supplement	Arm I, Arm II, Arm III, Arm IV

Primary outcome

Pattern of Response of Serum 25(OH) D3 Levels
Time frame: Baseline, at 1, 3, 6 months
Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.

3 secondary outcomes

Pattern of Response of Parathormone
Time frame: Baseline, at 1, 3, 6 months
Toxicity
Time frame: Baseline, at 1, 3 and 6 months
Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls
Time frame: Baseline, at 1, 3 ,6 months

Results and safety

Results posted to the registry on 2 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I: Vitamin D 4000 IU Daily	37	34
Arm II: Vitamin D 6000 IU Daily	35	34
Arm III: Vitamin D 8000 IU Daily	36	33
Arm IV: Vitamin D 10,000 IU Daily	40	34

Primary outcome: Pattern of Response of Serum 25(OH) D3 Levels

Time frame: Baseline, at 1, 3, 6 months. Mean (Standard Deviation). Unit: ng/mL

Measure	Arm I: Vitamin D 4000 IU Daily n = 33	Arm II: Vitamin D 6000 IU Daily n = 31	Arm III: Vitamin D 8000 IU Daily n = 32	Arm IV: Vitamin D 10,000 IU Daily n = 32
1-month	11.34 (13.03)	24.84 (16.18)	18.87 (22.25)	26.91 (16.1)
3-month	23.45 (11.99)	38.31 (22.24)	35.76 (26.28)	45.67 (21.5)
6-month	27.16 (15.69)	43.4 (29.28)	41.7 (27.07)	57.59 (27.91)

Arm I: Vitamin D 4000 IU Daily: p <.0001, t-test, 2 sided
Arm I: Vitamin D 4000 IU Daily: p <.0001, t-test, 2 sided
Arm I: Vitamin D 4000 IU Daily: p <.0001, t-test, 2 sided

Population analysed: All treated and eligible patients

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I: Vitamin D 4000 IU Daily	2 of 37 (5.4%)	3 of 37 (8.1%)	Not reported
Arm II: Vitamin D 6000 IU Daily	0 of 35 (0%)	3 of 35 (8.6%)	Not reported
Arm III: Vitamin D 8000 IU Daily	1 of 36 (2.8%)	3 of 36 (8.3%)	Not reported
Arm IV: Vitamin D 10,000 IU Daily	5 of 40 (12.5%)	9 of 40 (22.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

Active, not recruiting
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Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
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Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Recruiting
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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.

Donald L. Trump, MD principal investigator

Roswell Park Cancer Institute

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 cholecalciferol in people with Prostate Cancer, run by Roswell Park Cancer Institute at 1 site in United States.

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 3 inclusion and 4 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 2 Nov 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 United States. 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?

Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pattern of Response of Serum 25(OH) D3 Levels (time frame: Baseline, at 1, 3, 6 months). 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 NCT00524680.

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 2 Nov 2015.