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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA090270 | U.S. NIH Grant/Contract | View source | |
| NCI-2010-01369 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.
Advanced prostate cancer may be responsive to a combination of hormonal and chemotherapy treatments. Researchers believe that the use of chemotherapy and hormonal therapy before your scheduled surgery may help to affect or delay the progression of prostate cancer.
Before surgery, you will have imaging studies, including a chest x-ray, CT scan and a bone scan. You may also have an MRI scan. These tests are being done to check on the status of the disease. You will also have 3 tablespoons of blood drawn for routine blood tests, before treatment.
All treatment will be given on an outpatient basis. Treatment should start as soon as possible, within 14 days after registration. You will receive hormonal treatment once a month for the 12 months before your surgery. Hormonal treatments will not continue after the surgery.
You will be given dexamethasone, Benadryl® (diphenylhydramine) and Pepcid® (famotidine) , by a vein in your arm or by central line in a vein before your therapy begins with docetaxel on Day 1 of the first treatment cycle. Dexamethasone will help decrease bone marrow inflammation. Diphenhydramine helps prevent allergic reactions. Famotidine protects you against stomach irritation by decreasing the amount of acid in your stomach.
Docetaxel will be given through a needle in your vein (IV) once a week during the first 4 weeks of each 6-week period (called a study cycle). Each dose of docetaxel will take about an hour to be given. The total treatment time to complete the docetaxel will be 3 study cycles (18 weeks). Before each 6-week study cycle with docetaxel, you will come to the clinic for a physical exam and routine blood tests (2 tablespoons).
After your treatment with docetaxel and hormones, you will then have an operation to remove the prostate gland and the tumor. Your doctor will discuss the surgical procedure with you in detail and explain the risks of the operation. You will need to sign a separate consent form before undergoing the surgical procedure.
After surgery, you will be closely checked for any possible side effects. After completion of the treatment, you will be monitored every 3 months for the first year and every 6 months for the second year. You will also have 2 tablespoons of blood drawn for routine blood test monitoring at every follow-up visit.
This is an investigational study. Docetaxel and the hormone treatments used in this study are FDA approved medications for the treatment of prostate cancer. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Hormones + Docetaxel | Experimental | Neoadjuvant Hormonal Therapy plus Docetaxel followed by Radical Prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Hormonal Therapy | Drug | Monthly or quarterly LHRH Agonist Depot injection (leuprolide or goserelin acetate) for one year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Progression Free at 1 Year | Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml - 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted. | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lance Pagliaro, MD, BA | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77007 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Of the 40 enrolled, one participant (2.5%) declined presurgical therapy after enrollment and was excluded from subsequent analyses.
Recruitment Period: Enrollment took place from 21 April 2005 to 31 March 2008. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Hormones + Docetaxel | One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant declined presurgical therapy after enrollment and was excluded from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Hormones + Docetaxel | One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants Progression Free at 1 Year | Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml - 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted. | One participant of 40 enrolled declined presurgical therapy after enrollment and was excluded from analysis. | Posted | Number | participants | 1 Year |
|
Adverse events collected through chemotherapy treatment and surgery, up to 18 weeks. One participant declined presurgical therapy after enrollment and was excluded from analysis.
All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neoadjuvant Hormones + Docetaxel | One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lance Pagliaro, MD | The University of Texas (UT) MD Anderson Cancer Center | 1-877-632-6789 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| D017273 | Goserelin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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|
| Docetaxel | Drug | 35 mg/m2 by vein (IV) on Day 1, 8, 15 and 22 every 6 weeks. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 39 |
| 39 |
| 39 |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gastrointestinal-Other (Specity) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin decrease | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage pulmonary/upper respiratory(Nose) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes Low (Total White Blood Count) | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration--Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular/Visual-Other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sodium serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Uric acid, serum-high (hyperuricemia) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Watery eye (epiphora, tearing) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Bladder spasms | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Superficial wound infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anastomotic urine leak | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Pelvic lymphocele | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anastomotic stricture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |