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Trial Title:
Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
NCT ID:
NCT06236789
Condition:
Prostatic Neoplasm
Conditions: Official terms:
Prostatic Neoplasms
Ifosfamide
Conditions: Keywords:
Castration-resistant prostate cancer
Ifosfamide/mesna
Efficacy
Safety
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Ifosfamide/mesna
Description:
Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression
Arm group label:
Castration-resistant prostate cancer patients treated with ifosfamide/mesna
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.
Criteria for eligibility:
Study pop:
Patients with metastatic castration-resistant prostate cancer
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Male
Gender based:
Yes
Gender description:
Patients with prostate cancer
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sang Joon Shin
Phone:
82-2-2228-8130
Email:
inspector@yuhs.ac
Start date:
November 2016
Completion date:
November 2026
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06236789
