Prostatic NeoplasmsPhase 2NCT00383487
A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
A Phase 2 study testing Calcitriol and Naproxen-n-butyl nitrate in people with Prostatic Neoplasms and Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer
- What is being tested?
- Calcitriol and Naproxen-n-butyl nitrate
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jul 2007
- 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 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must give written informed consent
- Histologically confirmed adenocarcinoma of the prostate
- Biochemical relapse after primary radiation therapy or surgery
- Normal testosterone levels
- 3 rising PSA after nadir, with interval between PSA determinations > 2 weeks
Who cannot join
- Local recurrence by CT scan
- Distant metastases by bone scan
- Hypercalcemia
- Nephrolithiasis
- Renal insufficiency (serum creatinine > 1.8 mg/dl)
- Pancreatitis
Show all 15Show fewer
- History of ulcer or gastrointestinal bleeding
- More than 6 months of hormone ablation therapy
- Concurrent therapy for prostate cancer
- Uncontrolled HTN
- H/O MI, CVA, TIA
- Known coronary disease/cerebrovascular disease
- Platelet counts <50
- Patients on anticoagulants
- Patients on lithium
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.
Read the detailed description
In summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown a promising role for both calcitriol and NSAIDs in the treatment of prostate cancer. Moreover, calcitriol and NSAIDs both exert their antiproliferative effect by decreasing prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to believe that their combined effects on prostaglandins may be synergistic. Preliminary in vitro assays in which calcitriol is given in combination with one of two different NSAIDs (Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation provides the rational for using them in combination for the treatment of prostate cancer. In addition, it is hoped that any synergy noted would allow for the use of lower doses of NSAIDs.
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Being tested
- Calcitriol, Naproxen-n-butyl nitrate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called 1,25-Dihydroxycholecalciferol, 1,25-dihydroxyvitamin D3
0.5 micrograms/kilogram q weekly
Naproxen-n-butyl nitrateDrug
Also called Naprosyn
400 mg BID, oral
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
Secondary outcomes (1)
Progressive disease in this study's patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startMar 2005
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: Extreme toxicity
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Novacea
- Responsible party
- Principal investigator, Sandy Srinivas, Stanford University
- Investigators
- Dr. Sandy Srinivas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383487
- Sponsor's protocol ID
- PROS0021
- Other IDs
- 95804
- Status last verified
- Jan 2013
- First submitted
- 29 Sep 2006
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00383487
- Acronym / sponsor ID
- PROS0021
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extreme toxicity
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Novacea
- Study start
- Mar 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 3 Oct 2006 (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.
To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.
Detailed description
In summary, in vitro and in vivo studies, as well as early phase clinical trial, have shown a promising role for both calcitriol and NSAIDs in the treatment of prostate cancer. Moreover, calcitriol and NSAIDs both exert their antiproliferative effect by decreasing prostaglandin levels, but they do so by different mechanisms. Thus, there is reason to believe that their combined effects on prostaglandins may be synergistic. Preliminary in vitro assays in which calcitriol is given in combination with one of two different NSAIDs (Naprosyn or sulindac) to LNCaP cell lines have indicated such synergy. This observation provides the rational for using them in combination for the treatment of prostate cancer. In addition, it is hoped that any synergy noted would allow for the use of lower doses of NSAIDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must give written informed consent
- Histologically confirmed adenocarcinoma of the prostate
- Biochemical relapse after primary radiation therapy or surgery
- Normal testosterone levels
- 3 rising PSA after nadir, with interval between PSA determinations > 2 weeks
Key exclusion criteria (15 listed)
- Local recurrence by CT scan
- Distant metastases by bone scan
- Hypercalcemia
- Nephrolithiasis
- Renal insufficiency (serum creatinine > 1.8 mg/dl)
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 |
|---|---|---|
| CalcitriolAlso: 1,25-Dihydroxycholecalciferol, 1,25-dihydroxyvitamin D30.5 micrograms/kilogram q weekly | Drug | – |
| Naproxen-n-butyl nitrateAlso: Naprosyn400 mg BID, oral | Drug | – |
Primary outcome
PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
1 secondary outcome
Progressive disease in this study's patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone.
Results and safety
The study was stopped early (reason given: Extreme toxicity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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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.
Dr. Sandy Srinivas principal investigator
Stanford University
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 Calcitriol and Naproxen-n-butyl nitrate in people with Prostatic Neoplasms and Prostate Cancer, run by Stanford University at 1 site 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 15 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: stopped early, as of the sponsor's last update on 28 Jan 2013. 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 was stopped early (reason given: Extreme toxicity). 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?
PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.. 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 28 Jan 2013.