Prostate CancerPhase 2NCT00018538
Calcifidol Therapy in Men With Cancer
A Phase 2 study testing calcifidiol in people with Prostate Cancer, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- calcifidiol
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Sep 2002
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Patients will be males with three successive rises in PSA after achieving a nadir post-definitive therapy. The following criteria must be met: pathologically confirmed prostate cancer, completion of definitive treatment in the form of local external beam radiation or definitive surgery and three successive rises in PSA with no clinical evidence of disease.
Trial locations and contacts
1 site in 1 country.
About this study
Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.
- Conditions
- Prostate Cancer
- Being tested
- calcifidiol
- Keywords
- vitamin D, prostatic neoplasms, neoplasm recurrence
- Medical subject headings
- Prostatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcifidiolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startOct 1999
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Guy Howard, Ph.DGary Schwartz, Ph.D, MPHJames Schlesselman, Ph.D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018538
- Sponsor's protocol ID
- ONCO-09-99S
- Status last verified
- Dec 2004
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcifidol Therapy in Men With Cancer
- ClinicalTrials.gov ID
- NCT00018538
- Acronym / sponsor ID
- ONCO-09-99S
- Conditions
- Prostate Cancer
- Keywords
- vitamin D, prostatic neoplasms, neoplasm recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 1999
- Study completion
- Sep 2002
- First posted
- 5 Jul 2001 (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.
Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| calcifidiol | Drug | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
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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.
Guy Howard, Ph.D
Gary Schwartz, Ph.D, MPH
James Schlesselman, Ph.D
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 calcifidiol in people with Prostate Cancer, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2009. 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?
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.
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 21 Jan 2009.