Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer

Recruiting

• Conditions: Prostatic Neoplasm
• Interventions: Drug: Ifosfamide/mesna

• Registration Number: NCT06236789
• Lead Sponsor: Yonsei University

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.

Detailed 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.

Study Timeline

• Study Start: 2016-11
• Status Verified: 2024-01
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Castration-resistant prostate cancer patients treated with ifosfamide/mesna	Ifosfamide/mesna	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	Up to 2 years	Summation of complete response partial response based on RECIST version 1.1

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 2 years	From date of treatment start to death
Number of patients with Adverse events based on CTCAE	Up to 2 years	Adverse events based on CTCAE

Trial Locations

Locations (1)

Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea; 🇰🇷 Seoul, Korea, Republic of