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

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
177 Lu-PSMA-I&T
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring 177Lu-PSMA-I&T, Prostate cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing First HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

177Lu-PSMA-I&T

Arm Description

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Adverse events collection
Adverse events within 2 months after the injection and scanning of patients will be followed and assessed

Full Information

First Posted
December 4, 2019
Last Updated
December 4, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04188587
Brief Title
177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer
Official Title
177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer
Keywords
177Lu-PSMA-I&T, Prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
177Lu-PSMA-I&T
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
177 Lu-PSMA-I&T
Intervention Description
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.
Primary Outcome Measure Information:
Title
PSA
Description
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%.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 2 months after the injection and scanning of patients will be followed and assessed
Time Frame
2 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Entry criteria ECOG score: 0-1 point Lymph and skeletal metastases or visceral metastases that cannot be removed surgically 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 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. Hemoglobin<80g/L;Hemameba<2.5×109/L;Thrombocyte<70g/L Glomerular filtration rate<50ml/min Serum creatinine>130umol/L;Total bilirubin>2mg/L;Albumin<30g/L. International normalized ratio（INR）>1,5 Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Wang, Ph.D
Phone
+8618951670836
Email
fengwangcn@hotmail.com
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Bu, M.S
Phone
+8602552271456
Email
1062238525@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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