C61
Conditions
Interventions
Group 1: Over a period of one year, the testosterone values, PSA values and other existing parameters relating to the type of therapy and the course of the disease are documented on a quarterly basis.
Sponsors
d-uo | Deutsche Uro-Onkologen e.V.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age >= 18 years 2. written informed consent and consent for the processing of personal data are available. 3. patients with advanced hormonal prostate carcinoma, in whom the indication for ADT exists and a corresponding drug treatment is planned independently of the participation in this study.
Exclusion criteria
Exclusion criteria: 1. bilateral orchiectomy 2. hypersensitivity to LHRH analogues according to the respective technical information 3. previous hormone therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quarterly documentation over 1 year: o Proportion of patients with achieved testosterone nadir of =20 ng/dl or =50 ng/dl. o Duration of effective suppression o Number of breakthroughs, i.e., increase in testosterone level >20 ng/dl or >50 ng/dl. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quarterly documentation over 1 year: 1. investigation of the quality of life (QoL) of the treated patients during the course of therapy. 2. investigation of the PSA-response and the PFS (progression free survival) in the different therapy subgroups 3. analysis of type and duration of flare-up prophylaxis used at therapy initiation 4. analysis of the anamnestic data of the examined patients in correlation to therapy course and outcome 5. investigation of the type and frequency of adverse drug reactions including tolerability at the site of administration | — |
Countries
Germany
Outcome results
None listed