Prostatic NeoplasmsNCT00482157
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
A study testing Vitamin D (Calcitriol) in people with Prostatic Neoplasms and Prostate Cancer, run by Stanford University.
Trial summary
After the diagnosis of prostate cancer, many men alter their lifestyle or diet or use various supplements in an attempt to retard the growth of their cancer. While there is limited data on the use of diet and supplements to alter the risk of prostate cancer, even less is known regarding the ability of diet or… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer
- What is being tested?
- Vitamin D (Calcitriol)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Nov 2007
- Phase
- Interventional
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:- Untreated prostate adenocarcinoma by an extended biopsy (>8 needle cores on systematic prostate biopsy) within 1 year of the screening date
- PSA <10.0 ng/ml
- Gleason sum 6 or <2 mm Gleason pattern 4
- No more than 33% of biopsy cores positive Exclusion Criteria:- Prior or concurrent treatment for prostate cancer
- Use of Finasteride, Dutasteride, Saw Palmetto
- Use of NSAIDs, COX-2 inhibitors and/or aspirin, soy or vitamin D supplements for more than 7 days over the one month prior to study
- Kidney disease, hypercalcemia or renal stones
- ECOG performance status >1
- Uncontrolled hypertension, unstable angina, history of transient ischemic attack (TIA), history of stroke.
About this study
After the diagnosis of prostate cancer, many men alter their lifestyle or diet or use various supplements in an attempt to retard the growth of their cancer. While there is limited data on the use of diet and supplements to alter the risk of prostate cancer, even less is known regarding the ability of diet or supplements to alter progression. For men who have elected active surveillance, the investigators propose to investigate the ability of vitamin D to retard the growth of prostate cancer.
Read the detailed description
Men will be randomized to each of two arms for a total of 24 subjects: calcitriol alone (DN101, 45 micrograms once weekly) or placebo. Baseline laboratory assays, including serum PSA, serum and urine calcium and creatinine, will be performed and the EPIC questionnaire (expanded prostate cancer index composite, validated HRQOL tool for prostate cancer patients) will be completed. Patients will also undergo prostate needle biopsy [4 cores taken under transrectal ultrasound (TRUS) guidance] to establish baseline levels of gene expression. Follow-up at the end of 2 weeks (just prior to the third dose) will include a history and physical, and a repeat of all baseline blood and urine tests. Follow-up at 3 months will include a history and physical, repeating all blood and urine tests, and the EPIC questionnaire. At 6 months, in addition to the history and physical, blood and urine tests, and the EPIC questionnaire, a TRUS-guided prostate needle biopsy will be performed. This will be a standard 12-core scheme and 4 of these cores will be used for laboratory analysis. Renal ultrasounds will again be performed on men in the calcitriol arms to look for stones. Patients who show no evidence of clinical progression will be offered to remain on study, in their designated treatment arm, for an additional 6 months. Any patient exhibiting clinical progression at any time will be withdrawn from the study and offered standard treatment options. For patients remaining on study at 12 months, an end-of-study biopsy will be requested (12-core scheme with 4 cores used for laboratory analysis)
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Being tested
- Vitamin D (Calcitriol)
- 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 D (Calcitriol)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in expression of biomarkers as assessed by prostate biopsy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph C. Presti Jr., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482157
- Sponsor's protocol ID
- PROS0022
- Other IDs
- 97408
- Status last verified
- Feb 2022
- First submitted
- 31 May 2007
- Last updated
- 3 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
- ClinicalTrials.gov ID
- NCT00482157
- Acronym / sponsor ID
- PROS0022
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 4 Jun 2007 (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.
After the diagnosis of prostate cancer, many men alter their lifestyle or diet or use various supplements in an attempt to retard the growth of their cancer. While there is limited data on the use of diet and supplements to alter the risk of prostate cancer, even less is known regarding the ability of diet or supplements to alter progression. For men who have elected active surveillance, the investigators propose to investigate the ability of vitamin D to retard the growth of prostate cancer.
Detailed description
Men will be randomized to each of two arms for a total of 24 subjects: calcitriol alone (DN101, 45 micrograms once weekly) or placebo. Baseline laboratory assays, including serum PSA, serum and urine calcium and creatinine, will be performed and the EPIC questionnaire (expanded prostate cancer index composite, validated HRQOL tool for prostate cancer patients) will be completed. Patients will also undergo prostate needle biopsy [4 cores taken under transrectal ultrasound (TRUS) guidance] to establish baseline levels of gene expression. Follow-up at the end of 2 weeks (just prior to the third dose) will include a history and physical, and a repeat of all baseline blood and urine tests. Follow-up at 3 months will include a history and physical, repeating all blood and urine tests, and the EPIC questionnaire. At 6 months, in addition to the history and physical, blood and urine tests, and the EPIC questionnaire, a TRUS-guided prostate needle biopsy will be performed. This will be a standard 12-core scheme and 4 of these cores will be used for laboratory analysis. Renal ultrasounds will again be performed on men in the calcitriol arms to look for stones. Patients who show no evidence of clinical progression will be offered to remain on study, in their designated treatment arm, for an additional 6 months. Any patient exhibiting clinical progression at any time will be withdrawn from the study and offered standard treatment options. For patients remaining on study at 12 months, an end-of-study biopsy will be requested (12-core scheme with 4 cores used for laboratory analysis)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| Vitamin D (Calcitriol) | Drug | – |
Primary outcome
changes in expression of biomarkers as assessed by prostate biopsy
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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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.
Joseph C. Presti Jr. principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (Calcitriol) in people with Prostatic Neoplasms and Prostate Cancer, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
changes in expression of biomarkers as assessed by prostate biopsy (time frame: 6 months). 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 3 Mar 2022.