Prostate Cancer
Conditions
Keywords
prostatectomy, docetaxel
Brief 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. 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.
Interventions
DRUGDocetaxel
Given by an IV infusion over 1 hour on day 2 of a three-week cycle
DRUGDexamethasone
Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel
DRUGEstramustine
Taken orally three times a day for 5 days for the first part of every three week cycle
DRUGZoladex
Given subcutaneously for 4 doses every three months
DRUGCasodex
Taken orally once a day for 6 months
PROCEDURERadical Prostatectomy
after the chemo and hormonal therapy all patients have a radiacal prostatectomy
Sponsors
Walter Reed Army Medical Center
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Docetaxel Followed by Radical Prostatectomy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 57 years |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 5 / 28 |
Outcome results
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.
Time frame: status post prostectomy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel Followed by Radical Prostatectomy | Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists | 0 participants |
95% CI: [0, 0.12]