177Lu‑P17‑087 and 177Lu‑P17‑088 treatment for metastatic castration‑resistant prostate cancer
Safety, Dosimetry and Dose-escalation of 177Lu-P17-087/177Lu-P17-088 in Patients With Metastatic Castration-resistant Prostate Cancer
This trial will test two new PSMA‑targeted radioactive drugs, 177Lu‑P17‑087 and 177Lu‑P17‑088, in men with metastatic castration‑resistant prostate cancer who have PSMA‑positive scans.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05603559 on ClinicalTrials.gov |
What this trial studies
This early‑phase pilot gives a single low activity dose of either 177Lu‑P17‑087 or 177Lu‑P17‑088 and uses serial whole‑body planar and SPECT/CT imaging over seven days to measure absorbed dose and monitor safety. All participants must have recent 68Ga‑PSMA PET/CT demonstrating high PSMA expression and will be imaged at multiple time points after injection (1.5, 4, 24, 48, 72, 120, and 168 hours). After initial safety and dosimetry from a 1.1 GBq dose, the protocol advances to sequential dose‑escalation cohorts at approximately 1.11, 2.96, and 4.44 GBq to identify the maximum tolerated or optimal biological dose. A subsequent dose‑expansion phase will further characterize pharmacokinetics, safety, and preliminary antitumor activity to establish a recommended Phase II dose.
Who should consider this trial
Good fit: Ideal candidates are men with progressive metastatic castration‑resistant prostate cancer, high PSMA uptake on recent 68Ga‑PSMA PET/CT, adequate bone marrow, liver, and kidney function, and no radionuclide therapy within the prior six months.
Not a fit: Patients with FDG‑positive but PSMA‑negative lesions, significant marrow/renal/hepatic impairment, or recent radionuclide therapy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these agents could provide longer tumor exposure to PSMA‑targeted radiation and potentially improve tumor control compared with shorter‑lived agents.
How similar studies have performed: PSMA‑targeted 177Lu therapies such as 177Lu‑PSMA‑617 have shown clinical benefit in mCRPC, but P17‑087 and P17‑088 are novel albumin‑binding derivatives and are less tested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy; * Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-P17-087/177Lu-P17-088. Exclusion Criteria: * Patients were excluded if they had \[18F\]FDG positive tumors without corresponding PSMA uptake. Patients were also not eligible if they accepted other radionuclide therapies within 6 months or had clinically significant impaired bone marrow, liver, or kidney function with a hemoglobin level of less than 9.0 g/dL, a white blood cell count of less than 2.5×109/L, a platelet count of less than 100×109/L and a serum creatinine \> 100 μmol/L.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, 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.