Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303713
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-27
Brief Title:
LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
LuCarbo - a Phase 1a1b Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The purpose of this study is to see whether the combination of a chemotherapy drug carboplatin along with the radioligand treatment 177Lu-PSMA-617 is safe in treating prostate cancer and whether the combination is effective in shrinking or preventing growth of prostate cancer
The names of the study drugs used in this research study are
Carboplatin A type of chemotherapy
177Lu-PSMA-617 A type of radioligand therapy
The names of the study drugs used in this research study are
Carboplatin A type of chemotherapy
177Lu-PSMA-617 A type of radioligand therapy
Detailed Description:
This is a phase 1 dose-escalation and dose-expansion trial of carboplatin in combination with 177Lu-PSMA-617 in participants with metastatic castrate-resistant prostate cancer mCRPC The study will take place in two parts Phase 1a to define the recommended phase 2 dose RP2D and Phase 1b to further assess safety and preliminary clinical activity of the combination regimen
The US Food and Drug Administration FDA has not approved carboplatin for prostate cancer but it has been approved for other uses
The US FDA has approved 177Lu-PSMA-617 as a treatment option for prostate cancer
The research study procedures include screening for eligibility and study treatment visits tumor biopsies x-rays Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans and blood tests
It is expected that about 35 people will take part in this research study
Novartis is supporting this research study by providing 177Lu-PSMA-617 as well as research funding
The US Food and Drug Administration FDA has not approved carboplatin for prostate cancer but it has been approved for other uses
The US FDA has approved 177Lu-PSMA-617 as a treatment option for prostate cancer
The research study procedures include screening for eligibility and study treatment visits tumor biopsies x-rays Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans Positron Emission Tomography PET scans and blood tests
It is expected that about 35 people will take part in this research study
Novartis is supporting this research study by providing 177Lu-PSMA-617 as well as research funding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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