Clinical trial · Observational
Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ifosfamide/mesna | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Castration-resistant prostate cancer patients treated with ifosfamide/mesna
- interventionNames
- Drug: Ifosfamide/mesna
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- Up to 2 years
- description
- Summation of complete response partial response based on RECIST version 1.1
Secondary outcomes (2)
- measure
- Number of patients with Adverse events based on CTCAE
- timeFrame
- Up to 2 years
- description
- Adverse events based on CTCAE
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKim 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