N/A
Completed N=300
Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia
Source: ClinicalTrials.gov NCT01320735 ↗Enrolled (actual)
300
Serious AEs
4.6%
Results posted
Jul 2015
Primary outcomePrimary: Mean Duration of Leuprorelin Exposure — 19.74; 21.25; 13.62 Months
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Leuprorelin Exposure |
19.74; 21.25; 13.62 | — |
| PRIMARY Mean Duration of Each Leuprorelin Cycle |
7.63; 5.60; 4.64; 3.44; 3.30; 7.68 | — |
| PRIMARY Median Number of Leuprorelin Cycles |
2 | — |
| PRIMARY Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen |
31.4; 15.2; 14.6; 62.2; 64.7; 0.0 | — |
| PRIMARY Number of Participants Who Switched to IAD Regimen by Visit |
237; 197 | — |
| SECONDARY Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC) |
36; 28; 8 | — |
| SECONDARY Median Time to Progression of HRPC |
17.12; 19.10; 8.11 | — |
| SECONDARY Median Time to Progression of HRPC in Participants Not Started on IAD Regimen |
12.8 | — |
| SECONDARY Median Survival Time |
18.94; 24.44; 12.76 | — |
| SECONDARY Mean Duration of Treatment-off Time in IAD Regimen |
7.12 | — |
| SECONDARY Median Percentage of Time Off-treatment During 2 Years IAD Regimen |
33.45 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed advanced PCa meeting the following criteria:
- Any Tumor, Node 1, Metastasis 0
- Any Tumor, Node 0, Metastasis 1 [according to Tumor Node Metastasis classification 2009]
- Participants planned for administration of leuprorelin
- World Health Organization status 0-1
- Life expectancy at least 2 years
Exclusion Criteria
- Contraindications to administration of leuprorelin:
- Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition
- Surgical castration
- Hormone-refractory PCa
- Presence of another malignant tumor (except skin cancer)
- Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens
- Previous administration of radiotherapy or chemotherapy course within 1 month
- Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion
- Extremely high level of PSA (greater than or equal to 1000 ng/ml)
- Other severe diseases in stage of decompensation
- Other contraindications, that make the participant's participation impossible (by investigator judgment)
- Previous enrollment in the present program
Data sourced from ClinicalTrials.gov (NCT01320735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.