177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer

NCT05613738 | Recruiting

• 1 other identifier: PUMCH-NM-PSMAEB01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-PSMA-EB-01, a new PSMA-specific radiopharmaceutical, in patients with metastatic castration resistant prostate cancer (mCRPC) who will undergo radioligand therapy (RLT). All patients underwent 68Ga-PSMA and 18F-FDG PET/CT for selection and were randomly divided into three groups of 3 people each.The three groups received an approximately 1.11 GBq (30mCi), 1.85 GBq (50 mCi) and 2.59 GBq (70mCi) of 177Lu-PSMA-EB-01 up to 2 cycles, respectively.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Dosimetry of normal organs and tumors

  The semiquantitative dosimetry will be performed based on SPECT/CT acquisitions after the first administration of 177Lu-PSMA-EB-01. The dose delivered to normal organs and tumors will be recorded.

  through study completion, an average of 4 weeks

• Hematologic adverse events collection

  Hematologic status were performed before and every 2 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0

  through study completion, an average of 6 months

• Hepatic and renal toxic events collection

  Liver function, and renal function were performed before and 4 weeks after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

  through study completion, an average of 6 months

Secondary Outcomes (1)

• PSA Response

  through study completion, an average of 6 months

Study Arms (3)

1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01

EXPERIMENTAL

All patients were intravenous injected with single dose 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

Drug: 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01

1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01

EXPERIMENTAL

All patients were intravenous injected with single dose 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

Drug: 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01

2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01

EXPERIMENTAL

All patients were intravenous injected with single dose 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

Drug: 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01

Interventions

1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 DRUG

All patients were intravenous injected with single dose 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01

1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 DRUG

All patients were intravenous injected with single dose 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01

2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 DRUG

All patients were intravenous injected with single dose 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours post-injection.

2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• progressive metastatic castration-resistant prostate cancer
• tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT

You may not qualify if:

• 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
• a serum albumin level of more than 3.0 g per deciliter
• cardiac insufficiency

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• Zang J, Wang G, Zhao T, Liu H, Lin X, Yang Y, Shao Z, Wang C, Chen H, Chen Y, Zhu Z, Miao W, Chen X, Zhang J. A phase 1 trial to determine the maximum tolerated dose and patient-specific dosimetry of [177Lu]Lu-LNC1003 in patients with metastatic castration-resistant prostate cancer. Eur J Nucl Med Mol Imaging. 2024 Feb;51(3):871-882. doi: 10.1007/s00259-023-06470-3. Epub 2023 Oct 21.

  PMID: 37864592 DERIVED

Study Officials

• Zhaohui Zhu Zhu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

86-13611093752; 13611093752@163.com

Guochang Wang, MD

CONTACT

86-18516822732; guochang1007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 14, 2022
• Study Start: November 23, 2022
• Primary Completion: June 30, 2025
• Study Completion: November 15, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

CN (1)