RecruitingRecruiting
Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
NCT06236789 · Yonsei University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
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
Study design
Enrollment target: 60 participants
Age groups: adult, older_adult
Timeline
Starts: 2016-11
Estimated completion: 2026-11
Last updated: 2024-02-01
Interventions
Drug: Ifosfamide/mesna
Primary outcomes
- • Objective response rate (Up to 2 years)
Sponsor
Yonsei University · other
Contacts & investigators
ContactSang Joon Shin · contact · inspector@yuhs.ac · 82-2-2228-8130
InvestigatorSang Joon Shin · principal_investigator, Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
All locations (1)
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of KoreaRecruiting
Seoul, South Korea