Study Stopped
Internal decision
Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in Prostate Cancer
LEPTO
Real-life Observational Study of Patients After 3-months of Leuprorelin 5mg Implant and Evaluation of Coping Strategies Among Patients With Prostate Cancer: LEPTO STUDY
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.
Trial Health
Trial Health Score
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Started Mar 2020
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedOctober 31, 2024
September 1, 2020
Same day
June 13, 2019
October 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The percentage of prostate cancer patients at 3 months who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant
The percentage of prostate cancer patients who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant will be evaluated at 3 months and at 6 months of follow-up
3 months
Interventions
Administration of Leptoprol implant every 3 months
Eligibility Criteria
Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).
You may qualify if:
- Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).
You may not qualify if:
- Patient who have already participated in another study or those who do not wish to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RECORDATI GROUPlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2019
First Posted
June 18, 2019
Study Start
March 1, 2020
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
October 31, 2024
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share