Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
Detailed description
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).
Interventions
DRUGEligard (TM)
Eligard (TM) 22.5 mg administered at baseline and Month 3
Sponsors
Sanofi-Synthelabo
Chesapeake Urology Research Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Must be outpatient, not hospitalized * Male Patient between ages 50-80, inclusive * Histologically/Cytologically graded adenocarcinoma of the prostate * Must have T1, T2 or T3a adenocarcinoma of the prostate * Must be a candidate for radiation therapy. Hormone refractory patients excluded * WHO/ECOG score of 0,1 or 2
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Testosterone Recovery | 6 mos | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessments | 6 months | 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 |
Participant flow
Recruitment details
Patients were enrolled from 2003-2008 at a medical office setting
Participants by arm
| Arm | Count |
|---|---|
| Single Arm- Eligard Eligard 22.5mg is only intervention administered | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Single Arm- Eligard |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 70.8 years STANDARD_DEVIATION 6.4 |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
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
Time frame: 6 mos
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm- Eligard | Serum Testosterone Recovery | 6 Months |
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
Time frame: 6 months
Population: data were not collected