Clinical trial · Interventional
Evaluate Recovery of Testosterone for Patients Using Eligard
A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Eligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer
NCT01136226CI-TRIAL-00035434EligardcompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eligard (TM) | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Eligard (TM)
- description
- Eligard (TM) administered 22.5mg
- interventionNames
- Drug: Eligard (TM)
Primary outcomes (1)
- measure
- Serum Testosterone Recovery
- timeFrame
- 6 mos
- description
- 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 outcomes (1)
- measure
- Safety Assessments
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.