Actively Recruiting
Led by Peking Union Medical College Hospital · Updated on 2024-07-10
9
Participants Needed
1
Research Sites
19 weeks
Total Duration
Researchers are evaluating the safety and dosimetry of a new radiopharmaceutical called 177Lu-PSMA-EB-01 in men with metastatic castration-resistant prostate cancer. This condition affects patients whose prostate cancer no longer responds to hormonal therapy. The study aims to measure how the drug distributes in the body and its preliminary effects, addressing challenges such as the short half-life and rapid clearance of previous treatments. This pilot study involves patients with tumors showing high PSMA expression confirmed by PET/CT scans. Participants are randomly assigned to one of three groups, each receiving a different single intravenous dose of 177Lu-PSMA-EB-01: approximately 1.11 GBq (30 mCi), 1.85 GBq (50 mCi), or 2.59 GBq (70 mCi). Each patient is monitored at multiple time points after injection—3 hours, 24 hours, 48 hours, 72 hours, and 168 hours—to assess drug distribution. The study allows up to two cycles of treatment, focusing on safety and absorbed radiation doses. During the study, researchers collect data on radiation doses absorbed by normal organs and tumors over about four weeks, and monitor blood, liver, and kidney-related side effects for up to six months. They also measure prostate-specific antigen (PSA) response within six months. Patients undergo regular imaging and laboratory tests to track safety and treatment effects. The entire participation period includes these follow-up assessments to provide comprehensive safety and dosimetry information.
CONDITIONS
177Lu-PSMA-EB-01 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)
Duration - Approximately 1 week
Participants receive a single intravenous dose of 177Lu-PSMA-EB-01 at one of three dose levels. They are monitored closely for safety and dosimetry following the treatment.
5 visits at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection
Duration - Up to 6 months
Participants are followed for safety monitoring and assessment of treatment effects over several months after receiving the treatment.
Visits scheduled periodically throughout the 6-month follow-up
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
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Jie Zang, Guochang Wang, Tianzhi Zhao...
https://pubmed.ncbi.nlm.nih.gov/37864592