Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer

NCT03780075 | Unknown Phase 1

• 1 other identifier: PekingUMCH-NM019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In prior studies, the investigators synthesized 177Lu-EB-PSMA-617 by conjugating a truncated Evans Blue (EB) molecule and DOTA chelator onto PSMA-617 and labeled it with 177Lu to increase the tumor accumulation and retention for radioligand therapy，and then the investigators evaluated the dosimetry of 177Lu-EB-PSMA-617 and response to single low-dose treatment in patients with metastatic castration-resistant prostate cancer(mCRPC). This study was performed to evaluate the safety and therapy response to 177Lu-EB-PSMA-617 in patients with mCRPC. This is an open-label, randomized study. Different groups with doses of 1.11GBq (30 mCi), 2.00 GBq (54 mCi) and 3.7GBq (100 mCi)of 177Lu-EB -PSMA617 will be injected intravenously. All patients will undergo 68Ga-PSMA PET/CT scans before and after the treatment.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC

  The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake in lesions will be measured.

  1 year

Secondary Outcomes (1)

• Adverse events collection

  patients will be monitored throughout the whole treatment period. Patients will be followed up every 3 month until 1 year for a long-term follow-up period.

Study Arms (3)

1.11GBq of 177Lu-EB-PSMA-617

EXPERIMENTAL

The patients were intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.

Drug: 1.11GBq of 177Lu-EB-PSMA-617

2.00 GBq of 177Lu-EB-PSMA-617

EXPERIMENTAL

The patients were intravenously injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.

Drug: 2.00 GBq of 177Lu-EB-PSMA-617

3.70GBq of 177Lu-EB-PSMA-617

EXPERIMENTAL

The patients were intravenously injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA617 and underwent 68Ga-PSMA PET/CT scans before and after the treatment.

Drug: 3.70GBq of 177Lu-EB-PSMA-617

Interventions

1.11GBq of 177Lu-EB-PSMA-617 DRUG

Patients were intravenous injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.

1.11GBq of 177Lu-EB-PSMA-617

2.00 GBq of 177Lu-EB-PSMA-617 DRUG

Patients were intravenous injected with the dose about 2.00 GBq (54 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.

2.00 GBq of 177Lu-EB-PSMA-617

3.70GBq of 177Lu-EB-PSMA-617 DRUG

Patients were intravenous injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.

3.70GBq of 177Lu-EB-PSMA-617

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 that did not respond to androgen-suppression therapy and/or systemic chemotherapy.
• Distant metastases with high PSMA expression confirmed by 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617.

You may not qualify if:

• a serum creatinine level of more than 150μmol 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 including carcinoid heart valve disease,
• a severe allergy or hypersensitivity to radiographic contrast material,
• claustrophobia, and pregnancy or breastfeeding.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Study Officials

• Zhaohui Zhu, MD,PHD

  Peking Union Medical College Hospital, Chinese Academy of Medical Science

  STUDY CHAIR

Central Study Contacts

Jie Zang, MD

CONTACT

+86 10 69154196; 15901495106@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: April 15, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Locations

CN (1)