Non-interventional study to the investigation of the quality of life in patients on Politrate Depot

Non-interventional study to the investigation of the quality of life in patients on Politrate Depot - NIS Politrate Depot

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009594

Enrollment

1000

Registered

2015-11-19

Start date

2015-12-01

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: For the participating patients the change of quality of life as part of the Lutrate(R) therapy will be determined over a period of 9 months compared to the baseline. For that the PORPUS-quest

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • male patient • Signed patient consent form • Age: = 18 Years • advanced, hormone-sensitive prostate carcinoma

Exclusion criteria

Exclusion criteria: • hypersensitivity to the active substances, to any of the excipients or to one of the other ingredients of politrate according to the summary of product characteristics

Design outcomes

Primary

Measure	Time frame
Collection on the change of the quality of life using the PORPUS-Questionnaires (Patient ORiented Prostate Utility Scale) during the Lutrate(R)-therapy over the period of therapy in comparison to the baseline. Measurement time: before start of therapy, as part of the first, the second (3 months after enrollment) and the fourth (9 months after enrollment) medication with Lutrate(R) Depot.	—

Secondary

Measure	Time frame
• Collecting safety data • Evaluation of the effectiveness of the treatment according to the course of PSA values and testosterone level (if existing) • Analysis of specifically prostate cancer anamnesis data • evaluation of the efficacy of treatment and of therapy by the physician • determination of adverse drug effects / adverse events; The evaluation by the doctor is done one time at the end of the observation as part of the "Follow Up". The doctor carries out the overall assessment of therapy in relation to efficacy and compatibility. In this connection he chooses between five possible answers, which are documented in the eCRF (very good, good, medium, rather bad, insufficient).	—

Measure

Time frame

• Collecting safety data • Evaluation of the effectiveness of the treatment according to the course of PSA values and testosterone level (if existing) • Analysis of specifically prostate cancer anamnesis data • evaluation of the efficacy of treatment and of therapy by the physician • determination of adverse drug effects / adverse events; The evaluation by the doctor is done one time at the end of the observation as part of the "Follow Up". The doctor carries out the overall assessment of therapy in relation to efficacy and compatibility. In this connection he chooses between five possible answers, which are documented in the eCRF (very good, good, medium, rather bad, insufficient).

—

Countries

Germany

Contacts

Public ContactLaura Langer

IQVIA Commercial GmbH & Co. OHG

LLanger@de.imshealth.com+ 49 152 53410880

Outcome results

None listed

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