on-interventional, prospective health services research study on the course of testosterone levels during androgen deprivation therapy (ADT) with LHRH analogues (3-month depot).
Recruiting
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00009995
- Lead Sponsor
- d-uo | Deutsche Uro-Onkologen e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 1000
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
1. bilateral orchiectomy
2. hypersensitivity to LHRH analogues according to the respective technical information
3. previous hormone therapy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quarterly documentation over 1 year:<br>o Proportion of patients with achieved testosterone nadir of =20 ng/dl or =50 ng/dl.<br>o Duration of effective suppression<br>o Number of breakthroughs, i.e., increase in testosterone level >20 ng/dl or >50 ng/dl.
- Secondary Outcome Measures
Name Time Method Quarterly documentation over 1 year:<br><br>1. investigation of the quality of life (QoL) of the treated patients during the course of therapy.<br>2. investigation of the PSA-response and the PFS (progression free survival) in the different therapy subgroups<br>3. analysis of type and duration of flare-up prophylaxis used at therapy initiation<br>4. analysis of the anamnestic data of the examined patients in correlation to therapy course and outcome<br>5. investigation of the type and frequency of adverse drug reactions including tolerability at the site of administration