Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546527
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Study of 177LuLu-PSMA-137 In Metastatic Castrate Resistant Prostate CancermCRPC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Study Evaluating the Pharmacokinetics Safety Tolerability and Efficacy of 177LuLu-PSMA-137 in Metastatic Castration Resistant Prostate CancermCRPC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective single-center single-arm clinical trial consisting of two parts In Part A 3 participants were enrolled to receive sequential administrations of low doses of 177LuLu-PSMA-137 and 177LuLu-PSMA-617 PharmacokineticsPK sampling and single-photon emission computed tomographycomputed tomography SPECTCT scans were performed at scheduled time according to the protocol Based on quantitative pharmacological results the optimal dosing regimen for 177LuLu-PSMA-137 was derived In Part B 3 participants were enrolled to receive treatments with 50 and 100 of the optimal dose of 177LuLu-PSMA-137 to preliminarily evaluate the safety tolerability radiation dosimetry and efficacy of 177LuLu-PSMA-137 in participants with metastatic castration resistant prostate cancer mCRPC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None