Prostate CancerPhase 2DProstateNCT00741364
Vitamin D Effects on Prostate Pathology
A Phase 2 study testing vitamin D3 (cholecalciferol) in people with Prostate Cancer, run by University of Toronto at 1 site in Canada.
Trial summary
There is much interest in understanding the role that vitamin D3 (cholecalciferol) plays in various cancers, and in the prognosis of various cancers once they are discovered. The purpose of this study is to examine the effects of vitamin D on prostate cancer-associated lesions and on vitamin D metabolites in prostate… Read more about this study
- Who is it for?
- Ages 30 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- vitamin D3 (cholecalciferol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Jul 2012
- 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 30 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a Gleason score 6 or 7 adenocarcinoma of the prostate biopsy
- Patient has elected to have a radical prostatectomy
- Patient is determined fit for surgery
- Normal renal and hepatic function
- Normal serum and urine calcium values
- Normal serum phosphate values
- Normal serum parathyroid hormone values
- Signed written informed consent
Who cannot join
- Prior use of neoadjuvant androgen deprivation therapy
- Prior use of 5 alpha reductase inhibitors (finasteride or dutasteride) in last 12 months
- Previous or concomitant anti-cancer therapy (chemotherapy, radiotherapy)
- Gleason score 8-10 adenocarcinoma as a biopsy diagnosis
- History of hypercalcemia/hypercalciuria
- History of renal disease
Show all 9Show fewer
- History of sarcoidosis
- Vitamin D (cholecalciferol) supplement > 1000 IU/day
- Inability to comply with a study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of the Effects of Vitamin D on Prostate Cancer-associated Lesions and on Vitamin D Metabolites in Prostate
There is much interest in understanding the role that vitamin D3 (cholecalciferol) plays in various cancers, and in the prognosis of various cancers once they are discovered. The purpose of this study is to examine the effects of vitamin D on prostate cancer-associated lesions and on vitamin D metabolites in prostate tissue. We will give vitamin D3 to men when they are scheduled to have their prostate removed because of cancer. The men will take vitamin D at one of 3 doses for 4-6 weeks, until the surgery is performed. We will compare the prostate tissue taken from the men receiving the higher doses of vitamin D to tissue from men assigned to the lower doses. We expect to find that the prostate removed at surgery from men who received the high-dose vitamin D treatment will appear more normal, and less cancer like. In addition, we will measure vitamin D metabolites in the prostate to confirm that these did accumulate in the prostate to bring about the effects observed.
Read the detailed description
Epidemiologic, laboratory, and clinical reports all suggest that vitamin D3 (cholecalciferol) plays a desirable role in the prevention and prognosis of prostate and other cancers. Prostate cancer cells possess both of the enzymes required to convert vitamin D to the active paracrine hormone, calcitriol. However, the dose-response relationship between serum levels of calcidiol (vitamin D status) and prostate tissue levels of calcidiol and calcitriol is yet to be defined. As a neoadjuvant, prior to radical prostatectomy (for 4-6 wk) vitamin D3 [400 IU (control group), 10,000 IU or 40,000 IU/day] will be given to 90 men randomized, double-blinded, 30 per dose. Immediately after surgery, the pathologist will obtain a few grams of prostate tissue, some of which will be used to assay calcidiol and calcitriol within prostate. From the embedded prostate, we will prepare immunohistochemically stained sections to characterize cellular responses and morphological changes. Our hypothesis is that vitamin D will increase intraprostate calcitriol concentration and thereby lower cellular proliferation (as judged by the markers MIB-1 and p27) in zones of Gleason pattern 3 prostate cancer and in pre-cancerous (PIN) lesions. We expect that our results will provide surrogate outcomes to justify larger trials of vitamin D for treatment of prostate cancer. This research has the potential to: 1. Provide direct evidence at the cellular level using clinical samples that vitamin D lowers cellular proliferation in prostate cancer, 2. Provide guidance about the serum calcidiol concentrations (and thereby vitamin D doses) that should be targeted for such studies, and 3. Eventually support other research directed at vitamin D as a primary prevention strategy.
- Conditions
- Prostate Cancer
- Being tested
- vitamin D3 (cholecalciferol)
- Keywords
- vitamin D, prostate cancer, prostatectomy, pathology, immunohistochemistry
- 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 D3 (cholecalciferol)Dietary supplement
liquid vitamin D solution (vitamin D3 in ethanol) taken daily at one of three possible doses (400, 10000, or 40000 IU/d) for 4-6 weeks prior to radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | vitamin D3 (400 IU/d) Receives: Dietary Supplement: vitamin D3 (cholecalciferol) |
| 2 | Active comparator | vitamin D3 (10,000 IU/d) Receives: Dietary Supplement: vitamin D3 (cholecalciferol) |
| 3 | Active comparator | vitamin D3 (40,000 IU/d) Receives: Dietary Supplement: vitamin D3 (cholecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunohistochemical markers of prostate pathology
Measured: end-of-study
intraprostate vitamin D metabolites
Measured: end-of-study
Secondary outcomes (6)
calcium (serum and urine)
Measured: biweekly
parathyroid hormone (PTH)
Measured: baseline, final
prostate specific antigen (PSA)
Measured: baseline, final
creatinine (serum and urine)
Measured: biweekly
phosphate (serum)
Measured: biweekly
serum vitamin D metabolites
Measured: baseline, final
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2012 (estimated)
- Study completionJul 2012 (estimated)
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.
- More trials run by University of TorontoThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, University Health Network, Toronto, Sunnybrook Health Sciences Centre, Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Reinhold Vieth, University of Toronto
- Investigators
- Reinhold Vieth, PhD, Principal investigator, University of Toronto, Mount Sinai HospitalDennis Wagner, MSc, Study director, University of Toronto, Mount Sinai HospitalTheo van der Kwast, MD, PhD, FRCPC, Principal investigator, University Health Network, TorontoNeil Fleshner, MD, MPH, FRCSC, Principal investigator, University Health Network, TorontoLaurence Klotz, MD, FRCSC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741364
- Sponsor's protocol ID
- M2140
- Acronym
- DProstate
- Status last verified
- Sep 2011
- First submitted
- 25 Aug 2008
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the Effects of Vitamin D on Prostate Cancer-associated Lesions and on Vitamin D Metabolites in Prostate
- ClinicalTrials.gov ID
- NCT00741364
- Acronym / sponsor ID
- DProstate / M2140
- Conditions
- Prostate Cancer
- Keywords
- vitamin D, prostate cancer, prostatectomy, pathology, immunohistochemistry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, University Health Network, Toronto, Sunnybrook Health Sciences Centre, Canadian Cancer Society (CCS)
- Study start
- Sep 2008
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 26 Aug 2008 (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.
There is much interest in understanding the role that vitamin D3 (cholecalciferol) plays in various cancers, and in the prognosis of various cancers once they are discovered. The purpose of this study is to examine the effects of vitamin D on prostate cancer-associated lesions and on vitamin D metabolites in prostate tissue. We will give vitamin D3 to men when they are scheduled to have their prostate removed because of cancer. The men will take vitamin D at one of 3 doses for 4-6 weeks, until the surgery is performed. We will compare the prostate tissue taken from the men receiving the higher doses of vitamin D to tissue from men assigned to the lower doses. We expect to find that the prostate removed at surgery from men who received the high-dose vitamin D treatment will appear more normal, and less cancer like. In addition, we will measure vitamin D metabolites in the prostate to confirm that these did accumulate in the prostate to bring about the effects observed.
Detailed description
Epidemiologic, laboratory, and clinical reports all suggest that vitamin D3 (cholecalciferol) plays a desirable role in the prevention and prognosis of prostate and other cancers. Prostate cancer cells possess both of the enzymes required to convert vitamin D to the active paracrine hormone, calcitriol. However, the dose-response relationship between serum levels of calcidiol (vitamin D status) and prostate tissue levels of calcidiol and calcitriol is yet to be defined. As a neoadjuvant, prior to radical prostatectomy (for 4-6 wk) vitamin D3 [400 IU (control group), 10,000 IU or 40,000 IU/day] will be given to 90 men randomized, double-blinded, 30 per dose. Immediately after surgery, the pathologist will obtain a few grams of prostate tissue, some of which will be used to assay calcidiol and calcitriol within prostate. From the embedded prostate, we will prepare immunohistochemically stained sections to characterize cellular responses and morphological changes. Our hypothesis is that vitamin D will increase intraprostate calcitriol concentration and thereby lower cellular proliferation (as judged by the markers MIB-1 and p27) in zones of Gleason pattern 3 prostate cancer and in pre-cancerous (PIN) lesions. We expect that our results will provide surrogate outcomes to justify larger trials of vitamin D for treatment of prostate cancer. This research has the potential to: 1. Provide direct evidence at the cellular level using clinical samples that vitamin D lowers cellular proliferation in prostate cancer, 2. Provide guidance about the serum calcidiol concentrations (and thereby vitamin D doses) that should be targeted for such studies, and 3. Eventually support other research directed at vitamin D as a primary prevention strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: vitamin D3 (cholecalciferol)vitamin D3 (400 IU/d) |
| 2 | Active comparator | Dietary Supplement: vitamin D3 (cholecalciferol)vitamin D3 (10,000 IU/d) |
| 3 | Active comparator | Dietary Supplement: vitamin D3 (cholecalciferol)vitamin D3 (40,000 IU/d) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of a Gleason score 6 or 7 adenocarcinoma of the prostate biopsy
- Patient has elected to have a radical prostatectomy
- Patient is determined fit for surgery
- Normal renal and hepatic function
- Normal serum and urine calcium values
Key exclusion criteria (9 listed)
- Prior use of neoadjuvant androgen deprivation therapy
- Prior use of 5 alpha reductase inhibitors (finasteride or dutasteride) in last 12 months
- Previous or concomitant anti-cancer therapy (chemotherapy, radiotherapy)
- Gleason score 8-10 adenocarcinoma as a biopsy diagnosis
- History of hypercalcemia/hypercalciuria
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 D3 (cholecalciferol)liquid vitamin D solution (vitamin D3 in ethanol) taken daily at one of three possible doses (400, 10000, or 40000 IU/d) for 4-6 weeks prior to radical prostatectomy | Dietary supplement | 1, 2, 3 |
Primary outcome
immunohistochemical markers of prostate pathology
Time frame: end-of-study
intraprostate vitamin D metabolites
Time frame: end-of-study
6 secondary outcomes
calcium (serum and urine)
Time frame: biweekly
parathyroid hormone (PTH)
Time frame: baseline, final
prostate specific antigen (PSA)
Time frame: baseline, final
creatinine (serum and urine)
Time frame: biweekly
phosphate (serum)
Time frame: biweekly
serum vitamin D metabolites
Time frame: baseline, final
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2011.
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RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 2
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RecruitingPhase 3
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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.
Reinhold Vieth, PhD principal investigator
University of Toronto, Mount Sinai Hospital
Dennis Wagner, MSc study director
University of Toronto, Mount Sinai Hospital
Theo van der Kwast, MD, PhD, FRCPC principal investigator
University Health Network, Toronto
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 vitamin D3 (cholecalciferol) in people with Prostate Cancer, run by University of Toronto at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 30 Sep 2011. 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 Canada. 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?
Results are not available in the source record.
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?
immunohistochemical markers of prostate pathology (time frame: end-of-study). The study lists 2 primary outcomes in all. 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 30 Sep 2011.