Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377683
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
Clinical Evaluation of 177Lu-DansyI-PSMA LNC1011 in Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
The First Affiliated Hospital of Xiamen University
Organization:
The First Affiliated Hospital of Xiamen University
Study Overview
Official Title:
An Open-Label Non-Randomized Single-Center Investigator-Initiated Trial to Determine the Safety Dosimetry and Preliminary Effectiveness of 177Lu-Dansyl-PSMA in Patients With Metastatic Castration-Resistant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ten to 20 of patients with prostate cancer PC experience progression in their disease even after undergoing pharmaceutical or surgical castration leading to metastatic CRPC mCRPC Prostate-specific membrane antigen PSMA is a membrane-bound glycoprotein mostly specific to the prostate While PSMA is expressed at low levels in normal prostate this expression increased by 100-1000-fold in PC which makes it a favorable target for therapy This study was designed to evaluate the safety tolerability and maximum tolerated dose of a long-lasting radiolabeled ligand 177Lu-Dansyl-PSMA in mCRPC patients
Detailed Description:
This proposal is a phase I open-label study of escalating doses of 177Lu-Dansyl-PSMA Injection in patients with PSMA-positive mCRPC The initial dose of 177Lu-Dansyl-PSMA is 185GBq 50 mCi and subsequent cohorts receive an incremental 50 dose increase until dose-limiting toxicity DLT is observed Treatment is planned for up to 2 cycles and the time interval between cycles is 6 weeks The primary endpoint assessed the safety and maximum tolerated dose of 177Lu-Dansyl-PSMA used for radioligand therapy in patients with PSMA-positive mCRPC Secondary endpoints included dosimetry and determination of the preliminary treatment efficacy of 177Lu-Dansyl-PSMA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None