Observation of Leuprone® HEXAL® in treatment practice. Noninterventional study on therapy over time, tolerability profile and on anamnestic factors.

• Conditions: MedDRA - 10071119 (Hormone-dependent prostate cancer); C61; Malignant neoplasm of prostate

• Registration Number: DRKS00005643
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-14
• Study Completion: 2020-06-05
• Results First Posted: 2021-06-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 1856

Inclusion Criteria

Patients receiving continuous androgen deprivation with Leuprone HEXAL for advanced hormone dependent prostate cancer; start of therapy with any GnRH analogue not longer than six months ago; only for patients receiving a GnRH analogue at enrolment: tumour response to therapy, no tumor progression under therapy; life expectancy at enrolment >12 months; ECOG class at enrolment 0 to 2; patient planned to receive therapy for at least 12 months at the time of inclusion; written informed consent covering retrospective and prospective documentation, transmission and analysis of data as well as source data verification during monitoring.

Exclusion Criteria

Surgical castration; therapy with the following therapies at enrolment: GnRH antagonist, androgen biosynthesis inhibitors, 3rd generation antiandrogens, systemic radiotherapy, chemotherapy (2nd line or higher; first line therapy eg. with docetaxel is permitted); contraindications for treatment with Leuprone HEXAL or specific risks according to the SmPC; earlier participation in this study; sufficient compliance not expected.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Extension of the available information on the therapy with Leuprone HEXAL, as determined by PSA and testosterone levels: documentation of all routinely collected lab values (schedule for documentation: inclusion in the study and after approximately 3, 6 and 12 months), calculation of the time to PSA or testosterone progression.<br>2. Extension of the available information on the tolerability profile of Leuprone HEXAL: documentation of adverse events and adverse drug reactions, calculation of frequencies.