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

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

1.11GBq of 177Lu-EB-PSMA-617

2.00 GBq of 177Lu-EB-PSMA-617

3.70GBq of 177Lu-EB-PSMA-617

About this trial

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

1.11GBq of 177Lu-EB-PSMA-617

2.00 GBq of 177Lu-EB-PSMA-617

3.70GBq of 177Lu-EB-PSMA-617

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events collection

Adverse events after the treatment of patients will be followed and assessed

Full Information

NCT ID

NCT03780075

First Posted

December 17, 2018

Last Updated

May 6, 2022

Sponsor

Peking Union Medical College Hospital

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

1. Study Identification

Unique Protocol Identification Number

NCT03780075

Brief Title

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

Official Title

Lu177-EB-PSMA617 Prostate-Specific Membrane Antigen Inhibitor Therapy in Patients With Castration-Resistant Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 15, 2018 (Actual)

Primary Completion Date

September 1, 2020 (Actual)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

Prostate cancer (PC) is the second most common cancer worldwide in men, with persistently high numbers dying from this disease. Recent studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in mCRPC. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA-617) and label it with 177Lu. The study is open-label and patients will be divided into three groups and monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events to evaluate the safety and therapy response to the 177Lu-EB-PSMA-617.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration-resistant Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1.11GBq of 177Lu-EB-PSMA-617

Arm Type

Experimental

Arm Description

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.

Arm Title

2.00 GBq of 177Lu-EB-PSMA-617

Arm Type

Experimental

Arm Description

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.

Arm Title

3.70GBq of 177Lu-EB-PSMA-617

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

1.11GBq of 177Lu-EB-PSMA-617

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

2.00 GBq of 177Lu-EB-PSMA-617

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

3.70GBq of 177Lu-EB-PSMA-617

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Adverse events collection

Description

Adverse events after the treatment of patients will be followed and assessed

Time Frame

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.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Zang, MD

Phone

+86 10 69154196

15901495106@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaohui Zhu, MD,PHD

Organizational Affiliation

Peking Union Medical College Hospital, Chinese Academy of Medical Science

Official's Role

Study Chair

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie Zang, MD

15901495106@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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