Prostate CancerPhase 2vit D & PCaNCT00953225
Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer
A Phase 2 study testing vitamin D3 in people with Prostate Cancer, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. Read more about this study
- Who is it for?
- Ages 19 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jan 2010to 30 Oct 2014
- 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 19 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male Veterans (> 18 years of age) recently diagnosed with low-risk PCa (histologically documented adenocarcinoma of the prostate)
- A serum PSA value of up to 10.0 ng/ml, and a Gleason score of six or less (three or less in either architectural pattern)
- For the purpose of eligibility, these additional criteria will be verified: *serum creatinine 2.0 mg/dL
- serum phosphate (measured as phosphorus) > 2.3 and < 4.8 mg/dL
- serum calcium > 8.5 and < 10.5 mg/dL
Who cannot join
- Subjects with any concurrent malignancy, except non-melanoma skin cancer
- Subjects with a history of sarcoidosis
- Subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation
- Subjects with a history of hypercalcemia
- Subjects who use lithium as a medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. The investigators propose to conduct a clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease monitored through active surveillance. The successful completion of this proposed clinical study will allow us to determine whether correcting vitamin D deficiency in Veterans diagnosed with early-stage prostate cancer will prevent progression of their disease and improve their prognosis.
Read the detailed description
Vitamin D promotes the differentiation of prostate cancer (PCa) cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical PCa to clinical disease. These considerations support the use of vitamin D3 as a chemopreventive agent.
We hypothesize that a daily dose of vitamin D3 (4,000 IU) taken for one year by Veterans diagnosed with low-risk, early-stage PCa, who are eligible for active surveillance will: a) result in a measurable decrease of serum PSA levels in a significant number of enrolled subjects, and b) be associated with a stabilization or improvement of their PCa pathology, as assessed through histological examination of prostate tissue biopsy specimens (Gleason score and percent of positive biopsies) obtained at the end of the study, as part of their standard medical care for active surveillance.
This VA Merit application proposes to conduct a randomized, placebo-controlled clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with early-stage prostate cancer, who elect to have their disease monitored through active surveillance (before considering definitive therapy). The main objectives of this proposed clinical study are as follows:
- To determine whether a daily supplement of 4,000 IU of vitamin D3 taken for twelve months will result in a measurable and significant decrease of serum PSA levels in Veterans diagnosed with low-risk, early stage PCa (Gleason score 6, PSA 10, clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.
- To determine in enrolled Veterans the pathology status of their PCa by analyzing prostate tissue biopsy specimens at the end of the study (Gleason score and percentage of positive biopsies), and by comparing them with those obtained before enrollment in this study, as part of their standard medical care.
The implementation of these proposed studies will allow us to assess whether vitamin D3 supplementation can be utilized as a chemopreventive regimen in Veterans diagnosed with low-risk, early stage PCa, and provide a useful addition to active surveillance.
- Conditions
- Prostate Cancer
- Being tested
- vitamin D3, Placebo daily for one year
- Keywords
- prostate cancer, vitamin D
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Drug
4,000 IU daily for one year
Placebo daily for one yearDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | 4,000 IU vitamin D3 daily for one year Receives: Drug: vitamin D3 |
| Placebo | Placebo comparator | Placebo daily for one year Receives: Drug: Placebo daily for one year |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA Slope (Trajectory) or the Change in PSA Level Over Time
Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.
Measured: 1 year (visits # 1-8)
Secondary outcomes (1)
Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment
Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study start7 Jan 2010
- Primary completion15 Dec 2013
- Study completion30 Oct 2014
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 VA Office of Research and DevelopmentThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Sebastiano Gattoni-Celli, MD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953225
- Sponsor's protocol ID
- CLIN-004-09S
- Other IDs
- MUSC IRB HR#19344
- Acronym
- vit D & PCa
- Status last verified
- Sep 2017
- First submitted
- 4 Aug 2009
- Last updated
- 9 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer
- ClinicalTrials.gov ID
- NCT00953225
- Acronym / sponsor ID
- vit D & PCa / CLIN-004-09S
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Medical University of South Carolina
- Study start
- 7 Jan 2010 (actual)
- Primary completion
- 15 Dec 2013 (actual)
- Study completion
- 30 Oct 2014 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. The investigators propose to conduct a clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease monitored through active surveillance. The successful completion of this proposed clinical study will allow us to determine whether correcting vitamin D deficiency in Veterans diagnosed with early-stage prostate cancer will prevent progression of their disease and improve their prognosis.
Detailed description
Vitamin D promotes the differentiation of prostate cancer (PCa) cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical PCa to clinical disease. These considerations support the use of vitamin D3 as a chemopreventive agent.
We hypothesize that a daily dose of vitamin D3 (4,000 IU) taken for one year by Veterans diagnosed with low-risk, early-stage PCa, who are eligible for active surveillance will: a) result in a measurable decrease of serum PSA levels in a significant number of enrolled subjects, and b) be associated with a stabilization or improvement of their PCa pathology, as assessed through histological examination of prostate tissue biopsy specimens (Gleason score and percent of positive biopsies) obtained at the end of the study, as part of their standard medical care for active surveillance.
This VA Merit application proposes to conduct a randomized, placebo-controlled clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with early-stage prostate cancer, who elect to have their disease monitored through active surveillance (before considering definitive therapy). The main objectives of this proposed clinical study are as follows:
- To determine whether a daily supplement of 4,000 IU of vitamin D3 taken for twelve months will result in a measurable and significant decrease of serum PSA levels in Veterans diagnosed with low-risk, early stage PCa (Gleason score 6, PSA 10, clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.
- To determine in enrolled Veterans the pathology status of their PCa by analyzing prostate tissue biopsy specimens at the end of the study (Gleason score and percentage of positive biopsies), and by comparing them with those obtained before enrollment in this study, as part of their standard medical care.
The implementation of these proposed studies will allow us to assess whether vitamin D3 supplementation can be utilized as a chemopreventive regimen in Veterans diagnosed with low-risk, early stage PCa, and provide a useful addition to active surveillance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: vitamin D34,000 IU vitamin D3 daily for one year |
| Placebo | Placebo comparator | Drug: Placebo daily for one yearPlacebo daily for one year |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male Veterans (> 18 years of age) recently diagnosed with low-risk PCa (histologically documented adenocarcinoma of the prostate)
- A serum PSA value of up to 10.0 ng/ml, and a Gleason score of six or less (three or less in either architectural pattern)
- For the purpose of eligibility, these additional criteria will be verified: *serum creatinine 2.0 mg/dL
Key exclusion criteria (5 listed)
- Subjects with any concurrent malignancy, except non-melanoma skin cancer
- Subjects with a history of sarcoidosis
- Subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation
- Subjects with a history of hypercalcemia
- Subjects who use lithium as a medication
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 |
|---|---|---|
| vitamin D34,000 IU daily for one year | Drug | Vitamin D3 |
| Placebo daily for one yearPlacebo | Drug | Placebo |
Primary outcome
PSA Slope (Trajectory) or the Change in PSA Level Over Time
Time frame: 1 year (visits # 1-8)
Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.
1 secondary outcome
Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sebastiano Gattoni-Celli, MD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vitamin D3 in people with Prostate Cancer, run by VA Office of Research and Development at 2 sites 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 5 inclusion and 5 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 6 Apr 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?
PSA Slope (Trajectory) or the Change in PSA Level Over Time (time frame: 1 year (visits # 1-8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2017.