---
title: Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
nct_id: NCT06236789
overall_status: RECRUITING
sponsor: Yonsei University
study_type: OBSERVATIONAL
primary_condition: Prostatic Neoplasm
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06236789.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06236789"
ct_last_update_post_date: 2024-02-01
last_seen_at: "2026-05-12T06:50:55.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer

**NCT ID:** [NCT06236789](https://clinicaltrials.gov/study/NCT06236789)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Yonsei University
- **Conditions:** Prostatic Neoplasm
- **Start Date:** 2016-11
- **Completion Date:** 2026-11
- **CT.gov Last Update:** 2024-02-01

## Brief 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.

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** MALE
- **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
```

## Arms

- **Castration-resistant prostate cancer patients treated with ifosfamide/mesna**

## Interventions

- **Ifosfamide/mesna** (DRUG) — Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression

## Primary Outcomes

- **Objective response rate** _(time frame: Up to 2 years)_ — Summation of complete response partial response based on RECIST version 1.1

## Secondary Outcomes

- **Number of patients with Adverse events based on CTCAE** _(time frame: Up to 2 years)_
- **Overall survival** _(time frame: Up to 2 years)_

## 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 — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.division of medical oncology, department of internal medicine, yonsei cancer center, yonsei university college of medicine, seoul, republic of korea|seoul||south korea` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06236789*  
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