Clinical trial · Interventional
Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
- 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)
Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study. Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (\<=50 ng/dL) through 52 weeks of treatment with an implant.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| histrelin acetate | Drug | Histrelin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- one histrelin acetate 50 mg implant
- description
- The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.
- interventionNames
- Drug: histrelin acetate
Primary outcomes (1)
- measure
- Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
- timeFrame
- 52 weeks
Secondary outcomes (3)
- measure
- PSA measurements
- timeFrame
- 52 weeks
- measure
- Pain measurements
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Key Inclusion Criteria: * Male Age 45 or older * Histologically confirmed adenocarcinoma of the prostate * Disease Staging III or IV * Clinical indication for androgen suppression therapy * Serum testosterone at least 150 ng/dL at screening * WHO Performance Scale 0 to 3 * Life expectancy of at least one year Key Exclusion Criteria: * Bilateral orchiectomy * Prior androgen-ablative therapy within past year * Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer) * Spinal cord compression
References
Publications (1)
- RESULTSchlegel PN; Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. J Urol. 2006 Apr;175(4):1353-8. doi: 10.1016/S0022-5347(05)00649-X. PMID 16515997