Clinical trial · Interventional
Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients.
Summary
Brief summary (as posted)
To identify the proportion of patients remaining medically castrated (testosterone level \< 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.
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 |
|---|---|---|---|
| Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
- timeFrame
- Day 240
Secondary outcomes (6)
- measure
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.
- timeFrame
- Day 120
- measure
- Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL.
- timeFrame
- Day 120 and 240
- measure
- Time to achieve castration in days post treatment (Tlag)
- timeFrame
- Day 35
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient * Patient must be 18 years old or over * Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy * Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment Exclusion Criteria: * Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy) * Patient who underwent a previous surgical castration * Prostate cancer therapy within 2 months of baseline visit * Patient with testosterone level below 150 ng/dL at screening
References
Publications (0)
Data not yet available