Metastatic Castration-resistant Prostate Cancer Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Nanjing First Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse events collection | Adverse events within 2 months after the injection and scanning of patients will be followed and assessed | 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04986423 -
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT05489991 -
A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05521412 -
EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T
|
Phase 1/Phase 2 | |
Terminated |
NCT04556617 -
PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
|
Phase 1/Phase 2 | |
Completed |
NCT02125357 -
Sequencing Abiraterone and Enzalutamide in mCRPC
|
Phase 2 | |
Recruiting |
NCT06052306 -
A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
|
Phase 1 | |
Recruiting |
NCT05917470 -
A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.
|
Phase 1/Phase 2 | |
Recruiting |
NCT05519449 -
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
|
Phase 1 | |
Terminated |
NCT05301062 -
A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
|
||
Recruiting |
NCT05383079 -
Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04060394 -
Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC
|
Phase 1/Phase 2 | |
Completed |
NCT01942837 -
Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05458544 -
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04879589 -
Phase 1 Study of ATRS-2002 in Healthy Male Adults
|
Phase 1 | |
Recruiting |
NCT03230734 -
Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05116579 -
Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
|
||
Active, not recruiting |
NCT03732820 -
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05005728 -
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05762536 -
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
|
Phase 2 |