Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03990194
Status:
UNKNOWN
Last Update Posted:
2020-10-01
First Post:
2019-06-13
Brief Title:
Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in Prostate Cancer
Sponsor:
Laboratoires Bouchara-Recordati
Organization:
Laboratoires Bouchara-Recordati
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEPTO
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
Detailed Description:
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
The psychological dimension of the management of patients with prostate cancer will also be addressed by evaluating the strategies used by patients to cope with their prostate cancer Prostate Cancer Patients Coping Strategies Questionnaire PCPCSQ
The psychological dimension of the management of patients with prostate cancer will also be addressed by evaluating the strategies used by patients to cope with their prostate cancer Prostate Cancer Patients Coping Strategies Questionnaire PCPCSQ
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None