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| Name | Class |
|---|---|
| Sanofi-Synthelabo | INDUSTRY |
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The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eligard (TM) | Other | Eligard (TM) administered 22.5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eligard (TM) | Drug | Eligard (TM) 22.5 mg administered at baseline and Month 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Testosterone Recovery | To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer | 6 mos |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessments | Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator.
Used the following treatments for prostate Cancer
*immunotherapy *chemotherapy *External Beam Radiation *brachytherapy *hormonal therapy *biological response modifiers
Prior Prostate Surgery (excluding TUNA or TURP)
Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs
Use of Investigational Drug, Biologic or device within five half-lives of its physiological action or three months prior to base line, whichever is longer
Over the counter or alternative medical therapies which have estrogenic or anti-androgenic effect
uncontrolled CHF within 6 months to baseline
Myocardial Infarct, coronary vascular procedure or Clinically SignificantCardiovascualr Disease within 6 months of baseline Visit
Venous thrombosis with in 6 Months of Screening
Uncontrolled Hypertension defined as >170/100 or Symptomatic Hypotension within 3 months of Baseline
Insulin dependant Diabetic Patients Must not administer in an anatomic region where they will receive Eligard.
Drug or Alcohol Abuse 6 months prior to Baseline
Other Serious Illness at the discretion of the Investigator
Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose for 3 months prior to Baseline
Hypersensitivity to GnRH, GnRH agonists
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Patients were enrolled from 2003-2008 at a medical office setting
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm- Eligard | Eligard 22.5mg is only intervention administered |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm- Eligard | Eligard 22.5mg is only intervention administered |
| 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 | Serum Testosterone Recovery | To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer | Posted | Mean | Full Range | Months | 6 mos |
|
|
2 years
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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 | Single Arm- Eligard | Eligard 22.5mg is only intervention administered |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Thomas, Administrator | Chesapeake Urology Research Associates | 443.471.5742 | hthomas@cua.md |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C493311 | luprolide acetate gel depot |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Safety Assessments | Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire | data were not collected | Posted | 6 months |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |