Observation Study to Evaluate the Efficacy and Safety of... | NCT06236789

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

NCT06236789

Sponsor

Yonsei University

Status

Recruiting

Last Update Posted

Feb 1, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Prostatic Neoplasm

Interventions

Ifosfamide/mesna

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Nov 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Jan 24, 2024

First Submission Date that Met QC Criteria

Jan 24, 2024

First Posted Date

Feb 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2024

Last Update Posted Date

Feb 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Castration-resistant prostate cancer patients treated with ifosfamide/mesna			Drug: Ifosfamide/mesna

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ifosfamide/mesna	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate	Summation of complete response partial response based on RECIST version 1.1	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with Adverse events based on CTCAE	Adverse events based on CTCAE	Up to 2 years
Overall survival	From date of treatment start to death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Patients with prostate cancer

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with metastatic castration-resistant prostate cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sang Joon Shin	Contact	82-2-2228-8130		inspector@yuhs.ac

Overall Officials

Name	Affiliation	Role
Sang Joon Shin	Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea	Recruiting	Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40506027	Derived	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. 2026 Apr;58(2):603-612. doi: 10.4143/crt.2025.155. Epub 2025 Jun 9.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D003520	Cyclophosphamide
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds