Clinical trial · Interventional
Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients
Randomised, Phase III Multicenter, Open Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients Presenting Elevated Chromogranin A Levels
NCT01313273CI-TRIAL-00041870POSEIDONterminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor enrolment
Summary
Brief summary (as posted)
The aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non metastatic castrate resistant prostate cancer patients.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lanreotide, non steroidal anti androgens and LHRH-a | Drug | — | UNRESOLVED |
| Non steroidal anti androgens and LHRH-a | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A
- interventionNames
- Drug: Non steroidal anti androgens and LHRH-a
- type
- EXPERIMENTAL
- label
- Arm B
- interventionNames
- Drug: Lanreotide, non steroidal anti androgens and LHRH-a
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Week 96
Secondary outcomes (3)
- measure
- Prostate Specific Antigen (PSA) Response
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven diagnosis of prostate cancer * Evidence of PSA progression despite castrate levels of testosterone (\<50 ng/dL) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (LHRH-a) * Patients with non-metastatic or stable metastatic disease * Chromogranin A elevation above normal range (confirmed by a second evaluation at least 1 week later) \[cut off levels will be \> 20 U/L for enzyme linked immunosorbent (ELISA) assay and \> 100 ng/ml for immunoradiometric (IRMA) assay\] Exclusion Criteria: * Patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel) * First line treatment with antiandrogen in monotherapy * Visceral metastasis * Previous or concomitant treatment with a somatostatin analogue
References
Publications (0)
Data not yet available
No reference posted for this study.