Precancerous/Nonmalignant ConditionPhase 2NCT00118066
Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
A Phase 2 study testing calcitriol and observation in people with Precancerous/Nonmalignant Condition and Prostate Cancer, run by Rutgers, The State University of New Jersey at 5 sites in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known whether calcitriol is more effective than observation in preventing prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Precancerous/Nonmalignant Condition, Prostate Cancer
- What is being tested?
- calcitriol and observation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2004to Aug 2011
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed high-grade prostatic intraepithelial neoplasia
- Diagnosed within the past 6 months
- No evidence of prostate cancer within the past 6 months
- No evidence of palpable nodules on digital rectal exam
- Prostate specific antigen ≤ 10 ng/mL within the past 3 months
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- SGOT and SGPT ≤ 1.5 times upper limit of normal
Renal
- No uncontrolled renal failure
- No cancer-related hypercalcemia or kidney stones within the past 5 years
Cardiovascular
- No uncontrolled coronary artery disease
- No uncontrolled congestive heart failure
Other
- Prior malignancy allowed provided patient was curatively treated and has been disease-free for an appropriate time period for the specific cancer
- No known HIV positivity
- No active infection
- No major depression or suicidal ideation
- No other condition that would preclude study compliance
- No other uncontrolled medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for any malignancy
Endocrine therapy
- At least 2 weeks since prior and no concurrent finasteride (Prosear® or Propecia®) or other androgen suppressor
- No concurrent corticosteroids
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 2 weeks since prior phenytoin or phenobarbital
- At least 2 weeks since prior ketoconazole
- No concurrent administration of any of the following:
- Magnesium-containing antacids
- Thiazide diuretics
- Calcium supplements
- Digoxin
- Herbal supplements
- Pharmacological doses of cholecalciferol (vitamin D) or its derivatives
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, 08816
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, 08903
Overlook Hospital
Summit, New Jersey, 07901
About this study
Official title: A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known whether calcitriol is more effective than observation in preventing prostate cancer.
PURPOSE: This randomized phase II trial is studying how well calcitriol works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia.
Read the detailed description
OBJECTIVES:
- Determine the effects of calcitriol in patients with high-grade prostatic intraepithelial neoplasia.
- Determine the toxicity of this drug in these patients.
- Determine the effect of this drug on prostate specific antigen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses in the absence of unacceptable toxicity.
After completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol. Patients with no HGPIN or prostate cancer by biopsy are removed from the study.
- Arm II: Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I. Patients with no HGPIN or prostate cancer by biopsy are removed from the study.
After completion of study treatment, patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
- Being tested
- calcitriol, observation
- Keywords
- prostate cancer, high grade prostatic intraepithelial neoplasia
- Medical subject headings
- Precancerous Conditions, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcitriolDietary supplement
Given orally
observationProcedure or surgery
No initial intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses. After completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol. Receives: Dietary Supplement: calcitriol |
| Arm II | Other | Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I. Receives: Dietary Supplement: calcitriol; Procedure: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of prostate intraepithelial neoplasia after 16 weeks
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startMay 2004
- Primary completionJun 2011
- Study completionAug 2011
Why it stopped: Slow accruaL, lack of scientific progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precancerous/Nonmalignant ConditionStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Sponsor
- Investigators
- Robert S. DiPaola, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118066
- Sponsor's protocol ID
- 080404
- Other IDs
- P30CA072720, CDR0000433508, 0220044901, CINJ-NJ3803
- Status last verified
- May 2015
- First submitted
- 8 Jul 2005
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT00118066
- Acronym / sponsor ID
- 080404
- Keywords
- prostate cancer, high grade prostatic intraepithelial neoplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accruaL, lack of scientific progress
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- May 2004
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Jul 2005 (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.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known whether calcitriol is more effective than observation in preventing prostate cancer.
PURPOSE: This randomized phase II trial is studying how well calcitriol works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia.
Detailed description
OBJECTIVES:
- Determine the effects of calcitriol in patients with high-grade prostatic intraepithelial neoplasia.
- Determine the toxicity of this drug in these patients.
- Determine the effect of this drug on prostate specific antigen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses in the absence of unacceptable toxicity.
After completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol. Patients with no HGPIN or prostate cancer by biopsy are removed from the study.
- Arm II: Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I. Patients with no HGPIN or prostate cancer by biopsy are removed from the study.
After completion of study treatment, patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: calcitriolPatients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses. After completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol. |
| Arm II | Other | Dietary Supplement: calcitriol, Procedure: observationPatients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I. |
Who may qualify
- Ages
- 18 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 |
|---|---|---|
| calcitriolGiven orally | Dietary supplement | Arm I, Arm II |
| observationNo initial intervention | Procedure or surgery | Arm II |
Primary outcome
Presence of prostate intraepithelial neoplasia after 16 weeks
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Slow accruaL, lack of scientific progress). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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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.
Robert S. DiPaola, MD principal investigator
Rutgers Cancer Institute of New Jersey
5 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 calcitriol and observation in people with Precancerous/Nonmalignant Condition and Prostate Cancer, run by Rutgers, The State University of New Jersey at 5 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?
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: stopped early, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 was stopped early (reason given: Slow accruaL, lack of scientific progress). 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?
Presence of prostate intraepithelial neoplasia after 16 weeks (time frame: 4 years). 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 27 May 2015.