Prostatic NeoplasmNCT06236789
Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
An observational study of Prostatic Neoplasm, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Ifosfamide/mesna
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic castration-resistant prostate cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea
Seoul
Sang Joon Shin, 82-2-2228-8130, inspector@yuhs.ac
About this study
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.
Read the 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.
- Conditions
- Prostatic Neoplasm
- Being tested
- Ifosfamide/mesna
- Keywords
- Castration-resistant prostate cancer, Ifosfamide/mesna, Efficacy, Safety
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifosfamide/mesnaDrug
Ifosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Castration-resistant prostate cancer patients treated with ifosfamide/mesna | Not described Receives: Drug: Ifosfamide/mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Summation of complete response partial response based on RECIST version 1.1
Measured: Up to 2 years
Secondary outcomes (2)
Number of patients with Adverse events based on CTCAE
Adverse events based on CTCAE
Measured: Up to 2 years
Overall survival
From date of treatment start to death
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study startNov 2016
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang Joon Shin, Principal investigator, Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236789
- Sponsor's protocol ID
- 4-2023-1306
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Additional information reported in this study will be available upon request.
Publications
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.
PubMed 40506027
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06236789
- Acronym / sponsor ID
- 4-2023-1306
- Conditions
- Prostatic Neoplasm
- Keywords
- Castration-resistant prostate cancer, Ifosfamide/mesna, Efficacy, Safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Castration-resistant prostate cancer patients treated with ifosfamide/mesna | – | Drug: Ifosfamide/mesna |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic castration-resistant prostate cancer
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ifosfamide/mesnaIfosfamide 2,500 mg/m2/day for 3 days every 3 weeks with mesna until disease progression | Drug | Castration-resistant prostate cancer patients treated with ifosfamide/mesna |
Primary outcome
Objective response rate
Time frame: Up to 2 years
Summation of complete response partial response based on RECIST version 1.1
2 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 40506027Kim 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.
- Individual participant dataSharing planned: Undecided. Additional information reported in this study will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sang Joon Shin principal investigator
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasm, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sang Joon Shin (82-2-2228-8130, inspector@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.