RecruitingNCT06236789

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


Sponsor

Yonsei University

Enrollment

60 participants

Start Date

Nov 1, 2016

Study Type

OBSERVATIONAL

Conditions

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: MALEMin Age: 19 Years

Inclusion Criteria7

  • years and older adult male
  • Patients with histologically confirmed prostate cancer
  • Castration-resistant prostate cancer
  • ECOG 2 or less
  • Patients with previous docetaxel exposure
  • Patients with available PSA level
  • Patients with evaluable disease based on RECIST 1.1

Exclusion Criteria8

  • Patients with other primary cancers diagnosed within 3 years other than prostate cancer
  • Patients with a history of organ transplantation
  • Hormone sensitive prostate cancer
  • ECOG 3 or higher
  • Patients without previous docetaxel exposure
  • Patients previously exposed to ifosfamide
  • Patients without available PSA level
  • Patients without evaluable disease based on RECIST 1.1

Interventions

DRUGIfosfamide/mesna

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


Locations(1)

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

Seoul, South Korea

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NCT06236789


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