Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ifosfamide/mesna.
- Who it may be relevant to
- Registry conditions: Prostatic Neoplasm. Basic parameters: from 19 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Ifosfamide/mesna
Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression
Primary outcome measures
- Objective response rate [Time frame: Up to 2 years]
Secondary outcome measures (2)
- Number of patients with Adverse events based on CTCAE [Time frame: Up to 2 years]
- Overall survival [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 19 years and older adult male
- Patients with histologically confirmed prostate cancer
- Castration-resistant prostate cancer
- ECOG 2 or less
- Patients with previous docetaxel exposure
- Patients with available PSA level
- Patients with evaluable disease based on RECIST 1.1
Exclusion criteria
- Patients with other primary cancers diagnosed within 3 years other than prostate cancer
- Patients with a history of organ transplantation
- Hormone sensitive prostate cancer
- ECOG 3 or higher
- Patients without previous docetaxel exposure
- Patients previously exposed to ifosfamide
- Patients without available PSA level
- Patients without evaluable disease based on RECIST 1.1
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonse — Seoul
Publications
- Kim CG, Ko YG, Yoon J, Lee C, Beom SH, Choi YD, Han WK, Ham WS, Han H, Lee J, Heo JE, Kim D, Baek ES, Kim S, Jung M, Shin SJ. Efficacy and Safety of Ifosfamide and Mesna in Metastatic Castration-Resistant Prostate Cancer after Taxane-Based Chemotherapy and Novel Hormonal Therapy Failure. Cancer Res Treat. 2026 Apr;58(2):603-612. doi: 10.4143/crt.2025.155. Epub 2025 Jun 9. PMID 40506027
Identifiers
NCT: NCT06236789 · 4-2023-1306