New treatment for advanced prostate cancer using a radiopharmaceutical
Safety and Dosimetry of 177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer
NA · Peking Union Medical College Hospital · NCT05613738
This study is testing a new type of treatment for advanced prostate cancer to see if it can safely help patients by improving how the medicine targets tumors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Peking Union Medical College Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05613738 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and dosimetry of a novel radiopharmaceutical, 177Lu-PSMA-EB-01, in patients with metastatic castration-resistant prostate cancer (mCRPC). Participants will undergo imaging with 68Ga-PSMA and 18F-FDG PET/CT for selection and will be randomly assigned to receive one of three doses of the treatment. The goal is to improve tumor accumulation and reduce the dosage of Lu-177 by using Evans Blue to slow down plasma clearance. This approach aims to enhance the therapeutic potential of radioligand therapy in mCRPC patients.
Who should consider this trial
Good fit: Ideal candidates are men with progressive metastatic castration-resistant prostate cancer and high PSMA expression confirmed by imaging.
Not a fit: Patients with significant renal impairment, low blood counts, or cardiac insufficiency may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and safer option for patients with advanced prostate cancer.
How similar studies have performed: While this approach is innovative, similar studies using PSMA-targeted radiopharmaceuticals have shown promising results in treating prostate cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * progressive metastatic castration-resistant prostate cancer * tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT Exclusion Criteria: * a serum creatinine level of more than 150 μmol per liter * a hemoglobin level of less than 10.0 g/dl * a white-cell count of less than 4.0× 109/L * a platelet count of less than 100 × 109/L * a total bilirubin level of more than 3 times the upper limit of the normal range * a serum albumin level of more than 3.0 g per deciliter * cardiac insufficiency
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Zhaohui Zhu Zhu, MD — Peking Union Medical College Hospital
- Study coordinator: Zhaohui Zhu, MD
- Email: 13611093752@163.com
- Phone: 86-13611093752
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.
Conditions: Metastatic Castration-resistant Prostate Cancer