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Not Yet Recruiting NCT05603559

177Lu-P17-087/177Lu-P17-088 in Patients With Metastatic Castration-resistant Prostate Cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Sex: Male
Ages: 18 Years – 80 Years
Phase: EARLY_PHASE1
Enrollment: 10
Sponsor: Peking Union Medical College Hospital

Location: China

Summary

This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-P17-087/177Lu-P17-088 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-P17-087/177Lu-P17-088. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 1.1 GBq (30 mCi) of 177Lu-P17-087/177Lu-P17-088 within one week, then monitored at 3, 24, 48, 72 and 168 h after 177Lu-P17-087/177Lu-P17-088 administration with serial whole body planar and SPECT/CT imaging.

Eligibility 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:The exclusion criteria were 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 and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05603559). StuddyBuddy aggregates publicly available trial information.