Clinical trial · Interventional
Study of Histrelin Subdermal Implant in Patients With Prostate Cancer
Phase III, Open-Label Randomized, Parallel, Active-Control Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Metastatic Prostate Cancer
NCT01394263CI-TRIAL-00072658completedPhase 3ClinicalTrials.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)
This trial was an open-label, multi-national, randomized, parallel treatment, active-control multicenter study in adult males with documented metastatic prostate cancer disease who were judged to be candidates for hormone therapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histrelin hydrogel implant | Drug | — | UNRESOLVED |
| Zoladex goserelin implant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Zoladex goserelin implant.
- description
- Zoladex goserelin implant: D, L-lactic and glycolic acids copolymer. Injected subcutaneously into the upper abdominal wall.
- interventionNames
- Drug: Zoladex goserelin implant
- type
- EXPERIMENTAL
- label
- Histrelin Acetate implant
- description
- Histrelin hydrogel implant, 3 cm x 3.5 mm, containing 50 mg of histrelin acetate, surgically placed subdermally into the inner aspect of the upper arm.
- interventionNames
- Drug: Histrelin hydrogel implant
Primary outcomes (1)
- measure
- Suppression of testosterone via the percent of patients whose testosterone was at or below chemical castration levels (<=50 n/dL) through 52 weeks of treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Key Inclusion Criteria: * Male patients with histologically confirmed adenocarcinoma of the prostate * Disease staging of M1 or apparent failure of the initial definitive therapy (e.g., prostatectomy, radiation, etc.), suggested by either an elevated PSA (5 ng/mL or greater within the previous 28 days), or when below 5ng/mL, rising PSA values (elevation from previous measurement greater than or equal to 0.1 ng/mL on three consecutive measurements at least two weeks apart with at least one of these measurements being within the last 28 days which may include the Screening Visit result, if needed) * Clinically indicated for androgen suppression therapy * Age 45 years or older * Serum testosterone level of 150 ng/dL (5.25 nmol/L) or greater at screening * PSA level of 5ng/mL or greater within the previous 28 days, or an increase in PSA (elevation from previous measurements greater than or equal to 0.1ng/mL on three consecutive measurements at least two weeks apart) Key Exclusion Criteria: * Bilateral orchiectomy * Prior androgen-ablative or systemic corticosteroid therapy within the past year * Second malignancy within five years, except adequately treated nonmelanomatous skin cancer or superficial bladder cancer * Spinal cord compression * Location of vertebral metastases that indicate risk of spinal cord compression during initial treatment period in the opinion of the Investigator * Brain metastasis previously confirmed by CT scan
References
Publications (0)
Data not yet available
No reference posted for this study.