Prostate CancerPhase 2NCT01250717
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
A Phase 2 study testing Docetaxel, Dexamethasone and Estramustine in people with Prostate Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. 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?
- Docetaxel, Dexamethasone and Estramustine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 adenocarcinoma of the prostate
- Potential candidate for radical prostatectomy
- Any of the following: a) clinical stage T3 patients, b) Serum PSA greater than or equal to 20 ng/ml, c) Gleason score 8-10, d) Clinical T2 disease and either MRI evidence of seminal vesicle involvement or Gleason 4+3 cancer with either 5 or 6 biopsies positive
- ECOG Performance Status 0-1
- WBC > 3,000 ul
- HCT > 30%
- PLT > 100,000/ul
- LFTS within normal limits
Who cannot join
- Prior hormones, radiation or chemotherapy for prostate cancer
- Myocardial infarction within 1 year, significant change in anginal pattern within last 6 months, current congestive heart failure (NYHA Class 2 or higher), or deep venous thrombosis within 1 year
- Evidence of active infection
- Significant peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
About this study
The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.
Read the detailed description
- Participants will receive treatment in the outpatient clinic, where the docetaxel chemotherapy will be placed in a bag of fluid and will be given by vein every three weeks. Participants will take Decadron (dexamethasone) by mouth 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel. They will also take estramustine and casodex by mouth at home. Zoladex (or lupron) will be given subcutaneously (under the skin) 4 times every three months. They will also be started on coumadin beginning at the time of the first docetaxel infusion and continuing until 3 weeks after the 4th cycle of chemotherapy.
- After 2 months (or cycles) of therapy, participants will be evaluated in order to assess the response and toxicity of treatment, including a review of medical history, physical examination, blood tests, including PSA. If there is no evidence of progression or excessive toxicity, treatment will continue for 2 more months in the same manner.
- At the end of 4 months of chemotherapy, participants will be reassessed by the medical oncologist and urologist regarding surgery to remove the prostate.
- Conditions
- Prostate Cancer
- Being tested
- Docetaxel, Dexamethasone, Estramustine, Zoladex, Casodex
- Keywords
- prostatectomy, docetaxel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Given by an IV infusion over 1 hour on day 2 of a three-week cycle
DexamethasoneDrug
Also called Decadron
Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel
EstramustineDrug
Taken orally three times a day for 5 days for the first part of every three week cycle
ZoladexDrug
Also called goserelin acetate
Given subcutaneously for 4 doses every three months
CasodexDrug
Also called Bicalutamide
Taken orally once a day for 6 months
Radical ProstatectomyProcedure or surgery
after the chemo and hormonal therapy all patients have a radiacal prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel Followed by Radical Prostatectomy | Experimental | Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy Receives: Drug: Docetaxel; Drug: Dexamethasone; Drug: Estramustine; Drug: Zoladex; Drug: Casodex; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists
One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.
Measured: status post prostectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJan 2001
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Responsible party
- Principal investigator, Glenn Bubley, MD, Dana-Farber Cancer Institute
- Investigators
- Glenn J. Bubley, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250717
- Sponsor's protocol ID
- 2001P-001577
- Other IDs
- E-99-0363-FB
- Status last verified
- Aug 2012
- First submitted
- 23 Nov 2010
- Last updated
- 4 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT01250717
- Acronym / sponsor ID
- 2001P-001577
- Conditions
- Prostate Cancer
- Keywords
- prostatectomy, docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Study start
- Jan 2001
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Posted 4 Feb 2014
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 research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.
Detailed description
- Participants will receive treatment in the outpatient clinic, where the docetaxel chemotherapy will be placed in a bag of fluid and will be given by vein every three weeks. Participants will take Decadron (dexamethasone) by mouth 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel. They will also take estramustine and casodex by mouth at home. Zoladex (or lupron) will be given subcutaneously (under the skin) 4 times every three months. They will also be started on coumadin beginning at the time of the first docetaxel infusion and continuing until 3 weeks after the 4th cycle of chemotherapy.
- After 2 months (or cycles) of therapy, participants will be evaluated in order to assess the response and toxicity of treatment, including a review of medical history, physical examination, blood tests, including PSA. If there is no evidence of progression or excessive toxicity, treatment will continue for 2 more months in the same manner.
- At the end of 4 months of chemotherapy, participants will be reassessed by the medical oncologist and urologist regarding surgery to remove the prostate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel Followed by Radical Prostatectomy | Experimental | Drug: Docetaxel, Drug: Dexamethasone, Drug: Estramustine, Drug: Zoladex, Drug: Casodex, Procedure: Radical ProstatectomyDocetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Potential candidate for radical prostatectomy
- Any of the following: a) clinical stage T3 patients, b) Serum PSA greater than or equal to 20 ng/ml, c) Gleason score 8-10, d) Clinical T2 disease and either MRI evidence of seminal vesicle involvement or Gleason 4+3 cancer with either 5 or 6 biopsies positive
- ECOG Performance Status 0-1
- WBC > 3,000 ul
Key exclusion criteria (4 listed)
- Prior hormones, radiation or chemotherapy for prostate cancer
- Myocardial infarction within 1 year, significant change in anginal pattern within last 6 months, current congestive heart failure (NYHA Class 2 or higher), or deep venous thrombosis within 1 year
- Evidence of active infection
- Significant peripheral neuropathy
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 |
|---|---|---|
| DocetaxelAlso: TaxotereGiven by an IV infusion over 1 hour on day 2 of a three-week cycle | Drug | Docetaxel Followed by Radical Prostatectomy |
| DexamethasoneAlso: DecadronOrally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel | Drug | Docetaxel Followed by Radical Prostatectomy |
| EstramustineTaken orally three times a day for 5 days for the first part of every three week cycle | Drug | Docetaxel Followed by Radical Prostatectomy |
| ZoladexAlso: goserelin acetateGiven subcutaneously for 4 doses every three months | Drug | Docetaxel Followed by Radical Prostatectomy |
| CasodexAlso: BicalutamideTaken orally once a day for 6 months | Drug | Docetaxel Followed by Radical Prostatectomy |
| Radical Prostatectomyafter the chemo and hormonal therapy all patients have a radiacal prostatectomy | Procedure or surgery | Docetaxel Followed by Radical Prostatectomy |
Primary outcome
Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists
Time frame: status post prostectomy
One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Glenn J. Bubley, MD principal investigator
Beth Israel Deaconess Medical Center
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 Docetaxel, Dexamethasone and Estramustine in people with Prostate Cancer, run by Beth Israel Deaconess Medical Center 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 8 inclusion and 4 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 4 Feb 2014. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists (time frame: status post prostectomy). 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 4 Feb 2014.