Prostate CancerPhase 2NCT00181597
Trilostane for Androgen-Independent Prostate Cancer
A Phase 2 study testing Trilostane and Hydrocortisone in people with Prostate Cancer and Prostate Adenocarcinoma, run by Genzyme, a Sanofi Company at 2 sites in United States.
Trial summary
The main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Trilostane and Hydrocortisone
- Type of treatment
- Pill or oral medicine
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2004to Jan 2006
- 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
Who may be able to join
- Histologically confirmed prostate adenocarcinoma
- Disease progression despite androgen depravation therapy and antiandrogen withdrawal
- Progressive measurable disease or bone scan progression or PSA progression
- Serum total testosterone < 50ng/ml
- Creatinine < 2.0 mg/dl
- ALT < 2 x ULN
- CALGB performance status of 0,1, or 2
Who cannot join
- Radiation therapy within 4 weeks
- Antiandrogen within 8 weeks
- Other secondary hormonal therapy or investigational agents within 4 weeks
- Prior chemotherapy for androgen-independent prostate cancer
- History of adrenal insufficiency
- Known brain metastases
- Severe liver or renal disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer
The main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.
Read the detailed description
- Patients will take trilostane orally once a day for three days, then twice a day thereafter.
- Patients will complete a daily drug log recording the date, time and number of capsules taken.
- Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
- While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
- Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
- Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Trilostane, Hydrocortisone
- Keywords
- Trilostane, Androgen-independent 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.
TrilostaneDrug
Taken orally once a day for three days then twice daily thereafter.
HydrocortisoneDrug
Taken orally with trilostane.
What is being measured
The primary outcome is the main question the study is designed to answer.
activity of trilostane in men with androgen-independent prostate cancer.
Measured: 4 years
Secondary outcomes (1)
serum levels of gonadal and adrenal steroids
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 posted16 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionJan 2006
- Study completionJan 2006
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.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181597
- Sponsor's protocol ID
- 04-037
- Status last verified
- Dec 2013
- First submitted
- 9 Sep 2005
- Last updated
- 3 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00181597
- Acronym / sponsor ID
- 04-037
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- Trilostane, Androgen-independent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (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 main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.
Detailed description
- Patients will take trilostane orally once a day for three days, then twice a day thereafter.
- Patients will complete a daily drug log recording the date, time and number of capsules taken.
- Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
- While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
- Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
- Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.
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 (7 listed)
- Histologically confirmed prostate adenocarcinoma
- Disease progression despite androgen depravation therapy and antiandrogen withdrawal
- Progressive measurable disease or bone scan progression or PSA progression
- Serum total testosterone < 50ng/ml
- Creatinine < 2.0 mg/dl
Key exclusion criteria (7 listed)
- Radiation therapy within 4 weeks
- Antiandrogen within 8 weeks
- Other secondary hormonal therapy or investigational agents within 4 weeks
- Prior chemotherapy for androgen-independent prostate cancer
- History of adrenal insufficiency
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 |
|---|---|---|
| TrilostaneTaken orally once a day for three days then twice daily thereafter. | Drug | – |
| HydrocortisoneTaken orally with trilostane. | Drug | – |
Primary outcome
activity of trilostane in men with androgen-independent prostate cancer.
Time frame: 4 years
1 secondary outcome
serum levels of gonadal and adrenal steroids
Time frame: 4 years
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 3 Dec 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.
Medical Monitor study director
Genzyme, a Sanofi Company
2 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 Trilostane and Hydrocortisone in people with Prostate Cancer and Prostate Adenocarcinoma, run by Genzyme, a Sanofi Company at 2 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?
The sponsor lists 7 inclusion and 7 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 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
activity of trilostane in men with androgen-independent prostate cancer. (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 3 Dec 2013.