Clinical trial · Interventional
Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
NCT00056654CI-TRIAL-00001685completedN/AClinicalTrials.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 primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprolide acetate | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Leuprolide acetate
Primary outcomes (1)
- measure
- Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
- timeFrame
- Day 32 through Week 52
Secondary outcomes (4)
- measure
- Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
- timeFrame
- Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit
- measure
- Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of prostate cancer * Need for androgen deprivation treatment for 1 year * Serum testosterone level ≥ 150 ng/dL * Life expectancy of at least 18 months * ECOG Performance status grades 0,1 or 2 Exclusion Criteria: * Hypersensitivity to leuprolide acetate or polylactic acid * History of bilateral orchiectomy, adrenalectomy, or hypophysectomy * History of hypogonadism
References
Publications (0)
Data not yet available
No reference posted for this study.