NCT06236789 Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
| NCT ID | NCT06236789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Prostatic Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2016-11 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2016-11 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sang Joon Shin
PRINCIPAL INVESTIGATOR
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
Frequently Asked Questions
Who can join the NCT06236789 clinical trial?
This trial is open to male participants only, aged 19 Years or older, studying Prostatic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06236789 currently recruiting?
Yes, NCT06236789 is actively recruiting participants. Contact the research team at inspector@yuhs.ac for enrollment information.
Where is the NCT06236789 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06236789 clinical trial?
NCT06236789 is sponsored by Yonsei University. The principal investigator is Sang Joon Shin at Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine. The trial plans to enroll 60 participants.