177Lu‑P17‑087 and 177Lu‑P17‑088 treatment for metastatic castration‑resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JUR-003 in adults with advanced prostate cancer

  This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.

  Recruiting at 4 sites Phase 1 TCG Labs Soleil · Grand Rapids, Michigan and 3 other locations · NCT07824349

• SRT-017 radioligand therapy in PSMA-positive metastatic castration-resistant prostate cancer

  This study tests SRT-017 given by IV infusion to men with PSMA-positive metastatic castration-resistant prostate cancer to see if it is safe and tolerable and to gather early signals of anti-tumor activity.

  Recruiting Early Phase 1 Affiliated Hospital of Jiangnan University · Wuxi, Jiangsu · NCT07798778

• Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure

  This study tests whether adding rinzimetostat to darolutamide helps people with metastatic castration-resistant prostate cancer who previously took abiraterone.

  Recruiting at 15 sites Phase 3 ORIC Pharmaceuticals · Glendale, California and 14 other locations · NCT07723248

• FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer

  This study tests whether FX-111 is safe and can help treat metastatic castration-resistant prostate cancer in adult men.

  Recruiting at 7 sites Phase 1 Flare Therapeutics Inc. · Los Angeles, California and 9 other locations · NCT07719361

• Docetaxel and SX-682 in head and neck cancers and prostate cancer

  This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07667400

• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

  This trial tests ETB-DualNK-01, a dual-target CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer to see if it is safe and shows early signs of activity.

  Recruiting Phase 1 Beijing Biotech · Shenzhen, Guangdong · NCT07641049

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.