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Clinical Trials in South Korea / NCT06236789
Recruiting Observational

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

NCT06236789 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Observational
Started
2016-11
Last updated
2024-02-01

Condition(s) studied

Prostatic Neoplasm

Investigational drug(s) / intervention(s)

Ifosfamide/mesna

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

Study 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.

Eligibility

Sex
MALE
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Objective response rate — Up to 2 years
    Summation of complete response partial response based on RECIST version 1.1

Trial sites (1)

FacilityCityRegionStatus
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea Seoul South Korea Recruiting

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Other trials for the same condition

A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06236789 on ClinicalTrials.gov ↗ ← All trials in South Korea