Prostate CancerPhase 2NCT00186420
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
A Phase 2 study testing Taxotere in people with Prostate Cancer, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy. 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?
- Taxotere
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Sep 2009
- 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
- Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:
- Node positive disease post-operatively
- Capsule involvement
- Seminal Vesicles involvement
- Gleason score ≥ 8
- >50% of core biopsies that are positive
Show all 16Show fewer
- Clinical Stage T2c and T3
- Pre-op PSA > 15 plus Gleason score of 7
- Age greater than 18
- ECOG Performance Status 0-1
- Serum creatinine <= 1.5 mg/dl
- Granulocyte count >= 1500/m3, Hemoglobin > 8.0 g/dl, and platelet count >= 100,000/m3
- Total bilirubin <= ULN
- AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
- Signed patient informed consent.
- Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.
Who cannot join
- Peripheral neuropathy > grade 1
- History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.
- Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
- Active infection within 14 days of beginning treatment
- Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
- Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Cancer Center
Stanford, California, 94305
About this study
The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
- Conditions
- Prostate Cancer
- Being tested
- Taxotere
- Keywords
- Prostate Cancer, Taxotere
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaxotereDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
Measured: Following treatment
Secondary outcomes (2)
To evaluate the toxicity of taxotere and hormones given adjuvantly.
Measured: Following treatment
To measure Quality of Life on this therapy.
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 startJul 2003
- Primary completionJan 2006
- Study completionSep 2009
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Principal investigator, Sandy Srinivas, Stanford University
- Investigators
- Sandy Srinivas, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186420
- Sponsor's protocol ID
- PROS0004
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
- ClinicalTrials.gov ID
- NCT00186420
- Acronym / sponsor ID
- PROS0004
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Taxotere
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Jul 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Sep 2009 (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 purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
Study design
- Primary purpose
- Prevention
- 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 (16 listed)
- Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:
Key exclusion criteria (6 listed)
- Peripheral neuropathy > grade 1
- History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.
- Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
- Active infection within 14 days of beginning treatment
- Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
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 |
|---|---|---|
| Taxotere | Drug | – |
Primary outcome
To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
Time frame: Following treatment
2 secondary outcomes
To evaluate the toxicity of taxotere and hormones given adjuvantly.
Time frame: Following treatment
To measure Quality of Life on this therapy.
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 13 Jun 2012.
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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 2 study testing Taxotere 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 16 inclusion and 6 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 13 Jun 2012. 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 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?
To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy. (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 13 Jun 2012.