MedDRA - 10071119 (Hormone-dependent prostate cancer) C61
Conditions
Interventions
Group 1: Leuprone HEXAL 1- or 3-Monatsdepot is used following the instructions in Ch. 4.2 of the summary of product characteristics. The study documents routinely collected clinical data and laborator
Sponsors
Hexal AG
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. Extension of the available information on the tolerability profile of Leuprone HEXAL: documentation of adverse events and adverse drug reactions, calculation of frequencies. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Description of a correlation between different anamnestic factors and the course of PSA and testosterone over time: analyses of PSA or testosterone progression, tumour progression and changes of therapy in relation to body measures (e.g. body mass index, waist and hip circumference), blood pressure and metabolic parameters (as far as available). 2. Description of the initial therapy of patients treated with Leuprone HEXAL and of treatment changes over time and in relation to guideline updates. 3. Description of the use of Leuprone HEXAL: documentation of applied dose, dosage pattern, insertion procedure. 4. Description of concomitant diseases of patients, lifestyle (physical activity, diet) and sources of information on prostate carcinoma and therapy: handing out of patient questionnaires at inclusion into the study and at the end of the study. 5. Description of the study centres: patient groups treated, therapies used for prostate carcinoma, counselling of patients, role of guidelines, sources of information used – documentation in centre questionnaires at the start of the study. 6. Use of resources of the health care system: retrospective documentation of the visits to physicians and hospitals – at inclusion of the patient into the study and at the end of the study. | — |
Countries
Germany
Contacts
Public ContactCaroline Schneider
Institut Dr. Schauerte
Outcome results
None listed