Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in Prostate Cancer

Prostate Cancer Clinical Trial

— LEPTO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03990194
• Other study ID #: Leptoprol- FR-NIS 0023
• Status: Not yet recruiting
• Start date: March 30, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: September 2020
• Source: Laboratoires Bouchara-Recordati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: March 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).

Exclusion Criteria:

• Patient who have already participated in another study or those who do not wish to participate in this study.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Leuprolide Acetate
Administration of Leptoprol implant every 3 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Bouchara-Recordati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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