New treatment for advanced prostate cancer using a novel therapeutic probe
A Dosimetry Study and Dose-escalation and of [177Lu]Lu-LNC1011 in Metastatic Castration-Resistant Prostate Cancer Patients
PHASE1; PHASE2 · Peking Union Medical College Hospital · NCT06250244
This study is testing a new treatment for advanced prostate cancer to see if it is safe and effective for patients whose cancer has spread and is resistant to other therapies.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Peking Union Medical College Hospital (other) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06250244 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of 177Lu-LNC1011, a new long-circulating PSMA therapeutic probe, in patients with metastatic castration-resistant prostate cancer (mCRPC). The study employs an open-label, non-randomized design with a 3+3 dose-escalation approach, starting treatment at a dose of 1.85 GBq over six weeks and escalating doses by 50% until dose-limiting toxicity is observed. The primary goals are to determine the maximum tolerated dose, assess safety, and evaluate initial treatment efficacy in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are men with progressive metastatic castration-resistant prostate cancer and confirmed high PSMA expression.
Not a fit: Patients with significant renal impairment, low blood counts, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer that is resistant to standard hormone therapies.
How similar studies have performed: While this approach is novel, similar studies targeting PSMA in prostate cancer have shown promising results, indicating potential for success.
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 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
- Peking Union Medical College Hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Zhaohui 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, PSMA, 177Lu, mCRPC