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

Prostatic Neoplasm Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236789
• Other study ID #: 4-2023-1306
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

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