DOMINIC - Non-interventional Study about Dose modifications of Docetaxel in the therapy of metastatic castration resistant Prostate Cancer - DOMINIC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- Male
入选标准
- •histologically confirmed prostate cancer
- •-Prostate cancer is castration resistance
- •-By Hand signed and dated consent
排除标准
- •- Contraindications to the use of oxaliplatin LIV Pharma according to the SmPC.
- •- The patient is participating in a study at the same time.
