Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT06236789
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2016-11-30
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Castration-resistant prostate cancer patients treated with ifosfamide/mesna
Ifosfamide/mesna
Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression
Interventions
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Ifosfamide/mesna
Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
MALE
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Sang Joon Shin
Role: PRINCIPAL_INVESTIGATOR
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
Locations
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Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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. 2025 Jun 9. doi: 10.4143/crt.2025.155. Online ahead of print.
Other Identifiers
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4-2023-1306
Identifier Type: -
Identifier Source: org_study_id
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