Non-interventional study for the analysis of efficacy and safety of EstraCept(R) 280 mg (Estramustin phosphate) at patients with castration resistant prostate cancer in three therapy situations

Non-interventional study for the analysis of efficacy and safety of EstraCept(R) 280 mg (Estramustin phosphate) at patients with castration resistant prostate cancer in three therapy situations - EMPire

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003204

Enrollment

300

Registered

2011-08-03

Start date

2011-08-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: 1. Estramustin phosphate (EMP) as mono-therapy for cytostatic-naive patients with PSA-relapse after maximum androgen blockade. Initial dosis: Estracept(R) 280 mg: 3 x 1 hard capsule / day for

Eligibility

Sex/Gender

Male

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Castration resistant prostate cancer • Advanced status • Hormone refractory • Signed patient informed consent

Exclusion criteria

Exclusion criteria: As described in the product information

Design outcomes

Primary

Measure	Time frame
Primary outcome of this non-interventional study of the therapy of Estramustin phosphate (EMP) is the analysis of an increase of overall survival in the situation of progressive metastatic disease and to which extent a renewed increase of PSA can be delayed.	—

Secondary

Measure	Time frame
• Overall survival of the patients under the different therapy strategies • Impact on the quality of life measured by the PORPUS questionnaire • Detection of adverse drug reactions and adverse events	—

Countries

Germany

Contacts

Public ContactHeribert Stiegler

OnkoDataMed GmbH

heribert.stiegler@onkodatamed.de030 / 64 38 75 60

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026