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Recruiting Early Phase 1

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

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About this study

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 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours after 177Lu-P17-087/177Lu-P17-088 administration with serial whole body planar and SPECT/CT imaging.Following this initial safety assessment, the study will proceed to a dose-escalation phase designed to further evaluate safety and determine the optimal therapeutic activity. The dose-escalation phase will enroll patients into three sequential cohorts: a 1.11 GBq (30 mCi) dose group, a 2.96 GBq (80 mCi) dose group, and a 4.44 GBq (120 mCi) dose group.

Condition
Metastatic Castration-resistant Prostate Cancer
Tested
1.1 GBq (30 mCi) of 177Lu-P17-087, 1.1 GBq (30 mCi) of 177Lu-P17-088
Sponsor
Peking Union Medical College Hospital

Who can join

Age
18 to 90 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Maximum age: 90 years
  • Eligible sex: Male
  • Study condition: Metastatic Castration-resistant Prostate Cancer
  • 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 2

  • 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

1 site, 1 recruiting

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.