Actively Recruiting
Led by Peking Union Medical College Hospital · Updated on 2025-10-03
30
Participants Needed
1
Research Sites
108 weeks
Total Duration
Researchers are evaluating the safety, dosimetry, and preliminary antitumor activity of two new radiopharmaceutical treatments, 177Lu-P17-087 and 177Lu-P17-088, in men with metastatic castration-resistant prostate cancer (mCRPC) that has progressed despite androgen-suppression therapy or chemotherapy. This early-phase pilot study focuses on measuring the absorbed radiation dose using imaging and assessing side effects to determine the optimal therapeutic dose. Prostate-specific membrane antigen (PSMA) is targeted due to its presence on prostate tumor cells, with these new compounds designed to improve tumor uptake and blood clearance compared to earlier treatments. Participants receive a single intravenous injection of either 1.1 GBq (30 mCi) of 177Lu-P17-087 or 1.1 GBq (30 mCi) of 177Lu-P17-088. Following this, patients are monitored through multiple whole-body planar and SPECT/CT imaging sessions at 1.5, 4, 24, 48, 72, 120, and 168 hours post-injection to measure radiation dose and distribution. After this initial safety phase, the study will proceed to a dose-escalation phase with increasing doses across three groups: 1.11 GBq, 2.96 GBq, and 4.44 GBq, to further evaluate safety and find the best therapeutic dose. During the study, participants undergo repeated imaging and laboratory tests to assess radiation doses to organs and tumors, as well as monitoring for hematologic, liver, and kidney side effects. Researchers also track prostate-specific antigen (PSA) and PSMA responses to treatment. Monitoring continues for about two to three weeks after treatment for safety and response assessments. Total participation duration varies based on study phase and dose escalation steps, with careful observation to establish safe and effective dose levels.
CONDITIONS
177Lu-P17-087/177Lu-P17-088 in Patients With Metastatic Castration-resistant Prostate Cancer
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments including PSMA PET/CT within one week before treatment
Duration - Approximately 1 week
Participants receive a single intravenous dose of either 177Lu-P17-087 or 177Lu-P17-088 and are monitored for safety and dosimetry.
Multiple monitoring visits at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours, and 168 hours post-injection
Duration - Up to 3 weeks after treatment
Participants are followed up to assess hematologic, hepatic, renal safety and PSA response after treatment.
Periodic visits during follow-up up to 3 weeks after treatment
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Z
Zhaohui Zhu, MD
G
Guochang Wang, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Linlin Li, Jiarou Wang, Guochang Wang...
https://pubmed.ncbi.nlm.nih.gov/38658392