Clinical trial · Observational
Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer
A Non-interventional, Multi-centric, Observational, Prospective Study to Collect the Criteria on Which Renewal of GnRH Analogue Treatment With Triptorelin (Diphereline 3.75mg or Diphereline pr 11.25mg) is Made in Patients Recently Diagnosed With Prostate Cancer Requiring Androgen Deprivation Therapy
NCT02238366CI-TRIAL-00039737CHRONOS3completedClinicalTrials.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 collect some parameters which may help to provide guidance on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.
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 | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Prostate cancer patients
- description
- Patients recently diagnosed with prostate cancer requiring ADT.
- interventionNames
- Drug: triptorelin
Primary outcomes (2)
- measure
- Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.
- timeFrame
- 1 month
- description
- To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at 1-month +/- 7 days for Diphereline 3.75mg.
- measure
- Percentage of patients for whom the initial GnRH analogue formulation has been renewed.
- timeFrame
- 3 months
- description
- To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at at 3-months +/- 10 days for Diphereline PR 11.25mg (Visit 2).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month GnRH analogue triptorelin formulation * Expected survival \> 12 months. * Patients having provided written informed consent. * Patients mentally fit for completing a questionnaire. Exclusion Criteria: * Treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study. * Patients who already have been treated with a GnRH analogue within the last year. * Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients. * Patients with a contraindication according to SmPC.
References
Publications (0)
Data not yet available
No reference posted for this study.