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

Yonsei University

Status: Enrolling

Conditions: Prostatic Neoplasm

Treatments: Drug: Ifosfamide/mesna

Study type: Observational

Funder types: Other

Identifiers

NCT06236789

4-2023-1306

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Castration-resistant prostate cancer patients treated with ifosfamide/mesna

Treatment:

Drug: Ifosfamide/mesna