Evaluating a new treatment for metastatic prostate cancer using a radionuclide
A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer
This study is testing a new treatment called ZT-111 to see if it can safely target and help people with advanced prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | Huashan Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06201741 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the radionuclide labeled ZT-111 in patients with metastatic prostate cancer that expresses prostate-specific membrane antigen (PSMA). It focuses on understanding how the treatment distributes in the body, its radiation dosimetry, and how well it targets tumors. Patients will receive the ZT-111 treatment, and their responses will be monitored to gather data on its biodistribution and tumor uptake. The study aims to provide insights into the potential therapeutic benefits of this radionuclide in treating advanced prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 65 with confirmed metastatic prostate adenocarcinoma and documented metastatic lesions.
Not a fit: Patients with severe liver or kidney impairment or those who have recently undergone major surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a targeted approach to managing metastatic prostate cancer, potentially improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies using radionuclide therapies for prostate cancer have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 65 years old. 2. Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging. 3. Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver. 4. Willing and able to comply with all aspects of this study. Exclusion Criteria: 1. Severe hepatic or renal impairment. 2. History of major surgery within the last month. 3. Participation in another concurrent clinical trial.
Where this trial is running
Shanghai
- Huashan Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yihui Guan, MD
- Email: guanyihui@hotmail.com
- Phone: +86 13764308300
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.