Prostate CancerPhase 1NCT00186108
A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer
A Phase 1 study testing Oral Triamcinalone in people with Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Oral Triamcinalone
- Type of treatment
- Pill or oral medicine
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Sep 2005
- Phase
- Phase 1
- 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
Who may be able to join
- 18 years of age and older
- Histologically documented adenocarcinoma of prostate
- Currently receiving LHRH agonists with castrate levels of testosterone or who have had an orchiectomy
- Must have had a rise in PSA despite anti androgen withdrawal
- Exhibit 2 consecutive rise in PSA after the last hormonal manipulation
- Minimum PSA of greater than 5 KPS greater than 80%
Show all 9Show fewer
- Normal cortisol level at entry
- Life expectancy greater than 6 months
- Provide written consent pursuant to regulatory requirements prior to initiation of study procedure
Who cannot join
- Younger than 18 years
- Patients without prostate cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Cancer Center
Stanford, California, 94305
About this study
The primary purpose of this study is to evaluate the ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. Secondary goals are to describe the safety and tolerability at this dose and schedule, to determine the time to sustained biochemical response, to determine the duration of biochemical response, to determine the time to disease progression.
- Conditions
- Prostate Cancer
- Being tested
- Oral Triamcinalone
- Keywords
- Oral Triamcinalone, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral TriamcinaloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response.
Measured: Following treatment
Secondary outcomes (1)
Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression
Measured: Following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2002
- Study completionSep 2005
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 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Investigators
- Sandy Srinivas, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186108
- Sponsor's protocol ID
- PROS0006
- Status last verified
- Jul 2007
- First submitted
- 13 Sep 2005
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Oral Triamcinalone in Patients With Androgen Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00186108
- Acronym / sponsor ID
- PROS0006
- Conditions
- Prostate Cancer
- Keywords
- Oral Triamcinalone, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2002
- Study completion
- Sep 2005 (actual)
- First posted
- 16 Sep 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.
The primary purpose of this study is to evaluate the ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. Secondary goals are to describe the safety and tolerability at this dose and schedule, to determine the time to sustained biochemical response, to determine the duration of biochemical response, to determine the time to disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age and older
- Histologically documented adenocarcinoma of prostate
- Currently receiving LHRH agonists with castrate levels of testosterone or who have had an orchiectomy
- Must have had a rise in PSA despite anti androgen withdrawal
- Exhibit 2 consecutive rise in PSA after the last hormonal manipulation
Key exclusion criteria (2 listed)
- Younger than 18 years
- Patients without prostate cancer
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 |
|---|---|---|
| Oral Triamcinalone | Drug | – |
Primary outcome
Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response.
Time frame: Following treatment
1 secondary outcome
Safety and tolerability at this dose and schedule, time to sustained biochemical response, duration of biochemical response, time to disease progression
Time frame: Following treatment
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 25 Jul 2007.
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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.
Sandy Srinivas, MD 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 1 study testing Oral Triamcinalone in people with 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jul 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Ability of oral triamcinalone given twice a day to patients with androgen independent prostate cancer to produce a sustained biochemical response. (time frame: Following treatment). 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 25 Jul 2007.