NCT06236789

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Nov 2016Nov 2026

Study Start

First participant enrolled

November 1, 2016

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

10 years

First QC Date

January 24, 2024

Last Update Submit

January 24, 2024

Conditions

Prostatic Neoplasm

Keywords

Castration-resistant prostate cancerIfosfamide/mesnaEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Summation of complete response partial response based on RECIST version 1.1

    Up to 2 years

Secondary Outcomes (2)

  • Number of patients with Adverse events based on CTCAE

    Up to 2 years

  • Overall survival

    Up to 2 years

Study Arms (1)

Castration-resistant prostate cancer patients treated with ifosfamide/mesna

Drug: Ifosfamide/mesna

Interventions

Ifosfamide/mesnaDRUG

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

Castration-resistant prostate cancer patients treated with ifosfamide/mesna

Eligibility Criteria

Age19 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPatients with prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic castration-resistant prostate cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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

Related Publications (1)

  • Kim CG, Ko YG, Yoon J, Lee C, Beom SH, Choi YD, Han WK, Ham WS, Han H, Lee J, Heo JE, Kim D, Baek ES, Kim S, Jung M, Shin SJ. Efficacy and Safety of Ifosfamide and Mesna in Metastatic Castration-Resistant Prostate Cancer after Taxane-Based Chemotherapy and Novel Hormonal Therapy Failure. Cancer Res Treat. 2025 Jun 9. doi: 10.4143/crt.2025.155. Online ahead of print.

    PMID: 40506027DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

IfosfamideMesna

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicSulfhydryl CompoundsSulfur CompoundsSulfonic AcidsSulfur Acids

Study Officials

  • Sang Joon Shin

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Joon Shin

CONTACT

82-2-2228-8130inspector@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

November 1, 2016

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

KR(1)