Prostate Cancer
Conditions
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 \[(Prostate Cancer Patients' Coping Strategies Questionnaire (PCPCSQ)\].
Interventions
DRUGLeuprolide Acetate
Administration of Leptoprol implant every 3 months
Sponsors
RECORDATI GROUP
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 months | 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 |
Outcome results
None listed