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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age19+
SponsorYonsei University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

19 years and older adult male

Patients with histologically confirmed prostate cancer

Castration-resistant prostate cancer

ECOG 2 or less

Disqualifiers

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

Trial population

Patients with metastatic castration-resistant prostate cancer

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Ifosfamide/mesna

    Drug

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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Castration-resistant prostate cancer patients treated with ifosfamide/mesna1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

Summation of complete response partial response based on RECIST version 1.1

Time frame
Up to 2 years

Secondary outcomes

1

Number of patients with Adverse events based on CTCAE

Adverse events based on CTCAE

Time frame
Up to 2 years
2

Overall survival

From date of treatment start to death

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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