DOMINIC - Non-interventional Study about Dose modifications of Docetaxel in the therapy of metastatic castration resistant Prostate Cancer

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00007955
• Lead Sponsor: AxioNovo Gmbh

Brief Summary

Since the study was discontinued after inclusion of approximately 25% of the planned number of patients, data were only available for the evaluation of 162 instead of the planned 600 patients. Almost 2/3 of the patients completed the NIS regularly, in almost 1/4 of the patients the therapy was discontinued prematurely and in 7.4% of the patients the therapy was continued beyond the NIS period. The overall tolerability of chemotherapy with docetaxel (docetaxel axios) was rated as 'very good' in 16.7% of patients and 'good' in 50.0% of patients. The general condition of the patients deteriorated during participation in the NIS. The proportion of patients with an ECOG of 0 or 1 decreased from 85.9% to 61.7%, while the mean Karnofsky index deteriorated from 86.7 to 78.9. The FACT-P questionnaire showed a slight deterioration in patients' well-being in four of the five subscales (not in 'Emotional Well-Being') and in all three total scores.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-30
• Study Completion: 2022-11-15
• Results First Posted: 2023-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 168

Inclusion Criteria

histologically confirmed prostate cancer
-Prostate cancer is castration resistance
-By Hand signed and dated consent

Exclusion Criteria

- Contraindications to the use of oxaliplatin LIV Pharma according to the SmPC.
- The patient is participating in a study at the same time.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progressioin during therapy via clinical assessment or imaging.

Secondary Outcome Measures

Name	Time	Method
ack of Tolerability.