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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06236789
Other study ID # 4-2023-1306
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2016
Est. completion date November 2026

Study information

Verified date January 2024
Source Yonsei University
Contact Sang Joon Shin
Phone 82-2-2228-8130
Email inspector@yuhs.ac
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender Male
Age group 19 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Ifosfamide/mesna
Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression

Locations

Country Name City State
Korea, Republic of Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate Summation of complete response partial response based on RECIST version 1.1 Up to 2 years
Secondary Number of patients with Adverse events based on CTCAE Adverse events based on CTCAE Up to 2 years
Secondary Overall survival From date of treatment start to death Up to 2 years
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