Therapeutic Efficiency and Response to 2.0 GBq (55mCi) 177Lu-EB-PSMA in Patients With mCRPC

NCT ID: NCT04996602

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2022-12-01

Brief Summary

In recent years, quite a few studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in metastatic castration resistant prostate cancer (mCRPC), which has been shown desired effect. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, we conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu. This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.

Detailed Description

Prostate cancer is one of the most common cancers and the second most frequent cause of cancer deaths for adult men. With the advances in the diagnosis and treatment of prostate cancer, some patients with localized prostate cancer can achieve good curative results, but there are still 10%～20% of patients progress to metastatic castration-resistant prostate cancer (mCRPC) every year, only one third of patients with mCRPC survive more than five years. Radioligand therapy targeting prostate specific membrane antigen (PSMA), which is overexpressed in most prostate cancer and even further increased in metastatic and castration-resistant carcinomas, has been demonstrated as an effective and safe therapy in men with mCRPC. 177Lu-PSMA-617 has also shown desired effect. However, 177Lu-PSMA-617, as a small molecule imaging agent, is cleared very quickly from the circulation. Therefore, radiotherapy that is based on small molecules requires high doses and frequent administrations, leading to systemic toxicity. 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) and labeled it with 177Lu. The investigators have published some articles demonstrated 177Lu-EB-PSMA had much higher accumulation in prostate cancer lesions than 177Lu-PSMA-617 and also showed an ideal effect. This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2.0 GBq of 177Lu-EB-PSMA

The patients were intravenously injected with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA and underwent 68Ga-PSMA PET/CT scans before and after the treatment.

Group Type: EXPERIMENTAL

2.0 GBq of 177Lu-EB-PSMA

Intervention Type: DRUG

Patients were intravenous administrated with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA every 8 weeks (±1 week) for a maximum of 3 cycles.

Interventions

2.0 GBq of 177Lu-EB-PSMA

Patients were intravenous administrated with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA every 8 weeks (±1 week) for a maximum of 3 cycles.

Intervention Type: DRUG

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-EB-PSMA.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaohui Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaohui Zhu, MD

Role: CONTACT

13611093752@163.com

86-13611093752

Guochang Wang, MD

Role: CONTACT

guochang1007@163.com

86-18516822732

Facility Contacts

Zhaohui Zhu, MD

Role: primary

13611093752@163.com

86-13611093752

Guochang Wang, MD

Role: backup

guochang1007@163.com

86-18516822732

Other Identifiers

PekingUMCH Lu-EB-PSMA

Identifier Type: -

Identifier Source: org_study_id