177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to determine the safety and efficacy of 177 Lu -labeled PSMA ligand(PSMA-I＆T) in the treatment of mCRPC in Asianethics.

Study Overview

• Status: Unknown
• Conditions: Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: 177 Lu-PSMA-I&T

Detailed Description

Prostate specific membrane antigen(PSMA) targeted therapy brings new hope to the patients with metastatic castration-resistant prostate cancer (mCRPC). Here, we reported the safety and efficacy of 177 Lu -labeled PSMA ligand(PSMA-I＆T) in the treatment of mCRPC in Asianethics.

Prostate cancer is the most common cancer diagnosed in older men with recent data .PSMA is a type II transmembrane glycoprotein，overexpressed up to 100 to 1000 times higher than normal prostate cells in prostate cancer cells and is correlated with higher-grade cancers, metastatic disease and hormone refractory disease. Lutetium-177 (177Lu)-PSMA (LuPSMA) is a novel and highly targeted systemic RLT for progressive mCRPC. Upon binding of LuPSMA to the cell membrane, endocytosis is triggered, concentrating the tumouricidal effects of the radioisotope activity internally within malignant cells.

This is a single-institution, single-arm phase 2 clinical trial. Patients will receive PRLT Treatment. The follow-up period was followed up to assess safety and effectiveness.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: Ting Bu, M.S; Phone Number: +8602552271456; Email: 1062238525@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Entry criteria

1. ECOG score: 0-1 point
2. Lymph and skeletal metastases or visceral metastases that cannot be removed surgically
3. The disease continues to progress after treatment with ADT, chemotherapy, radiotherapy, or abiraterone and emzaludine 4.68Ga PSMA-11 PET / CT showed that there was significant radioactivity uptake in tumor tissues and metastases [SUVmax> 7], which was significantly higher than that in the liver.

Exclusion criteria

1. Previous treatment with any of the following within 6 months of randomization:

   Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.

2. Hemoglobin<80g/L;Hemameba<2.5×109/L;Thrombocyte<70g/L
3. Glomerular filtration rate<50ml/min
4. Serum creatinine>130umol/L;Total bilirubin>2mg/L;Albumin<30g/L.
5. International normalized ratio（INR）>1,5
6. Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 177Lu-PSMA-I&T; 177Lu-PSMA-I＆Tradioligand therapy with 2.0-8.0GBq in every circle were performed. And then 177Lu-PSMA post-therapy scans were performed at 24 h and 48 h respectively, and the fusion phenomenon was performed at the second day to pre evaluate the efficacy of the patients.	Drug: 177 Lu-PSMA-I&T; All patients were intravenous injected with single dose 2.0-8.0 GBq. The time of the next treatment cycle is determined according to the patient's condition, and it is recommended to treat once every 8-12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA	Serum prostate specific antigen (PSA) levels was used as the main marker of efficacy evaluation, and the changes of PSA level were divided into decrease > 50%, 30% ~ 50% and < 30%.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events collection	Adverse events within 2 months after the injection and scanning of patients will be followed and assessed	2 months

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Prostate cancer; 177Lu-PSMA-I&T
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: fengwang-177LU-PSMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No