Clinical trial · Observational
Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia
Prospective, Multi-Center, Observational Program to Assess Routine Use of Intermittent Adjuvant Deprivation Therapy With Lucrin Depot in Patients With Advanced Prostate Cancer in the Russian Federation
NCT01320735CI-TRIAL-00018491completedResults postedClinicalTrials.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 objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Advanced PCa
- description
- Participants with advanced PCa
Primary outcomes (5)
- measure
- Mean Duration of Leuprorelin Exposure
- timeFrame
- 24 months
- description
- Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.
- measure
- Mean Duration of Each Leuprorelin Cycle
- timeFrame
- 24 months
- description
- Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed advanced PCa meeting the following criteria: 1. Any Tumor, Node 1, Metastasis 0 2. Any Tumor, Node 0, Metastasis 1 \[according to Tumor Node Metastasis classification 2009\] 2. Participants planned for administration of leuprorelin 3. World Health Organization status 0-1 4. Life expectancy at least 2 years Exclusion Criteria: 1. Contraindications to administration of leuprorelin: 1. Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition 2. Surgical castration 2. Hormone-refractory PCa 3. Presence of another malignant tumor (except skin cancer) 4. Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens 5. Previous administration of radiotherapy or chemotherapy course within 1 month 6. Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion 7. Extremely high level of PSA (greater than or equal to 1000 ng/ml) 8. Other severe diseases in stage of decompensation 9. Other contraindications, that make the participant's participation impossible (by investigator judgment) 10. Previous enrollment in the present program
References
Publications (0)
Data not yet available
No reference posted for this study.