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NCT Number: NCT06236789

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

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.

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Key information

Conditions

Prostatic Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

Male

Study type

Observational

Primary location

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

Seoul, South Korea

Location status: Recruiting

Location contact

Sang Joon Shin

CONTACT

[email protected]

82-2-2228-8130

About this study

  • Retrospective analysis of the treatment outcomes of patients with metastatic castration-resistant prostate cancer who who received ifosfamide/mesna will be conducted.
  • 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.
  • Statistical method was applied to analyze the correlation between clinical indicators and survival rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 19 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 criteria

  • 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

Treatment and study plan

Ifosfamide/mesna

Drug

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

Primary outcomes

  1. Objective response rate

    Time frame: Up to 2 years

    Summation of complete response partial response based on RECIST version 1.1

Secondary outcomes

  1. Number of patients with Adverse events based on CTCAE

    Time frame: Up to 2 years

    Adverse events based on CTCAE

  2. Overall survival

    Time frame: Up to 2 years

    From date of treatment start to death

Study contacts

Contact information is provided by the study sponsor or research team.

Sang Joon Shin

CONTACT

[email protected]

82-2-2228-8130

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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