Prostatic Neoplasm
Conditions
Keywords
Castration-resistant prostate cancer, Ifosfamide/mesna, Efficacy, Safety
Brief summary
Prostate cancer is the 2nd most common cancer in men worldwide. Based on the results of several recent clinical trials, systemic treatments including hormone inhibitors, docetaxel, cabazitaxel, and PARP inhibitors are being used as standard treatment for patients with metastatic castration-resistant prostate cancer. However, there is insufficient research on salvage therapy for patients with metastatic castration-resistant prostate cancer who have failed standard treatment. In this study, the investigators will evaluate the effectiveness and safety of ifosfamide in castration-resistant prostate cancer by analyzing the treatment outcomes of patients who received ifosfamide/mesna treatment as salvage therapy.
Detailed description
1. Retrospective analysis of the treatment outcomes of patients with metastatic castration-resistant prostate cancer who who received ifosfamide/mesna will be conducted. 2. Information regarding demographics (age, gender, and etc.), disease status (stage, metastatic lesion, and etc.), treatment details (administered anticancer drugs, treatment response to drug, and disease progression with progression date), and survival (death with date of death) will be recorded. 3. Statistical method was applied to analyze the correlation between clinical indicators and survival rate.
Interventions
DRUGIfosfamide/mesna
Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 19 years and older adult male 2. Patients with histologically confirmed prostate cancer 3. Castration-resistant prostate cancer 4. ECOG 2 or less 5. Patients with previous docetaxel exposure 6. Patients with available PSA level 7. Patients with evaluable disease based on RECIST 1.1
Exclusion criteria
1. Patients with other primary cancers diagnosed within 3 years other than prostate cancer 2. Patients with a history of organ transplantation 3. Hormone sensitive prostate cancer 4. ECOG 3 or higher 5. Patients without previous docetaxel exposure 6. Patients previously exposed to ifosfamide 7. Patients without available PSA level 8. Patients without evaluable disease based on RECIST 1.1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Up to 2 years | Summation of complete response partial response based on RECIST version 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Adverse events based on CTCAE | Up to 2 years | Adverse events based on CTCAE |
| Overall survival | Up to 2 years | From date of treatment start to death |
Countries
South Korea
Contacts
Primary ContactSang Joon Shin
Outcome results
None listed