Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| E-99-0363-FB | Other Identifier | BIDMC IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Walter Reed Army Medical Center | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel Followed by Radical Prostatectomy | Experimental | Docetaxel,Dexamethasone,Estramustine,Zoladex,Casodex,Prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Given by an IV infusion over 1 hour on day 2 of a three-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | status post prostectomy |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Glenn J. Bubley, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
This was a single arm study and there were no arms. Participants were screened for final eligibility after consent was completed. All enrolled subjects were treated
Between September 28, 1999 and May 17, 2005, 28 participants with high risk localized prostate cancer were enrolled on this IRB approved phase II protocol from BIDMC Urology clinics
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel Followed by Radical Prostatectomy | This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below. Docetaxel Followed by Radical Prostatectomy Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy Zoladex : Given subcutaneously for 4 doses every three months Casodex : Taken orally once a day for 6 months Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel Followed by Radical Prostatectomy | This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below. Docetaxel Followed by Radical Prostatectomy Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy Zoladex : Given subcutaneously for 4 doses every three months Casodex : Taken orally once a day for 6 months Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | status post prostectomy |
|
6 months
followed for four cycles of therapy
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Docetaxel Followed by Radical Prostatectomy | This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below. Docetaxel Followed by Radical Prostatectomy Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy Zoladex : Given subcutaneously for 4 doses every three months Casodex : Taken orally once a day for 6 months Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenic fever | Blood and lymphatic system disorders | Systematic Assessment | defined as ANC < 500 and fever over 100 degrees farenheit |
Not provided
Although this study has the longest median follow-up periods reported (80 months or 6.6 years), the overall number of participants is too few to make strong judgements about efficacy
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn Bubley MD, Director of GU ONC | BIDMC | 617-735-2062 | gbubley@bidmc.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D004961 | Estramustine |
| D017273 | Goserelin |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexamethasone | Drug | Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel |
|
|
| Estramustine | Drug | Taken orally three times a day for 5 days for the first part of every three week cycle |
|
| Zoladex | Drug | Given subcutaneously for 4 doses every three months |
|
|
| Casodex | Drug | Taken orally once a day for 6 months |
|
|
| Radical Prostatectomy | Procedure | after the chemo and hormonal therapy all patients have a radiacal prostatectomy |
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below. Docetaxel Followed by Radical Prostatectomy Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy Zoladex : Given subcutaneously for 4 doses every three months Casodex : Taken orally once a day for 6 months Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel |
|
|
|
| 5 |
| 28 |
| 0 |
| 28 |
|
| elevated liver functions | Hepatobiliary disorders | Systematic Assessment | assessment by ALT and AST levels with 3.0 common toxicity criteria |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |