Evaluating Ifosfamide/Mesna for Advanced Prostate Cancer
Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
This study is testing whether a combination of ifosfamide and mesna can help people with advanced prostate cancer who haven't had success with other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | Male |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06236789 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of ifosfamide combined with mesna in patients suffering from metastatic castration-resistant prostate cancer. It involves a retrospective analysis of treatment outcomes for patients who have previously undergone standard therapies and are now receiving ifosfamide/mesna as salvage therapy. The study will collect demographic data, disease status, treatment details, and survival information to analyze correlations between clinical indicators and survival rates.
Who should consider this trial
Good fit: Ideal candidates include adult males aged 19 and older with histologically confirmed castration-resistant prostate cancer who have previously been treated with docetaxel.
Not a fit: Patients with hormone-sensitive prostate cancer or those who have previously been treated with ifosfamide will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new salvage therapy option for patients with metastatic castration-resistant prostate cancer who have exhausted standard treatment options.
How similar studies have performed: While there is limited research specifically on ifosfamide/mesna for this condition, other studies have explored various salvage therapies for metastatic castration-resistant prostate cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Sang Joon Shin — Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
- Study coordinator: Sang Joon Shin
- Email: inspector@yuhs.ac
- Phone: 82-2-2228-8130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.