Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867615
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-03-24
Brief Title:
Radiometabolic Therapy With 177Lu PSMA in PSMA PETCT Positive AdvancedMetastatic Tumours
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
Radiometabolic Therapy RMT With 177Lu PSMA in PSMA PETCT Positive AdvancedMetastatic Tumours a Basket Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
LUBASKET
Brief Summary:
Phase 2 study single arm trial enrolling patients with a Gallium-68Fluorine-18 prostate-specific membrane antigen PSMA positive positron emission tomographyComputed Tomography PETCT in order to be treated with Lutetium-177 177Lu PSMA
Patients without risk factors for toxicity will receive 74 GBq of 177Lu-PSMA while patients with at least 1 risk factor for toxicity will receive 55 GBq of 177Lu-PSMA Patients will receive 4 cycles every 8 weeks - 2 weeks
Patients without risk factors for toxicity will receive 74 GBq of 177Lu-PSMA while patients with at least 1 risk factor for toxicity will receive 55 GBq of 177Lu-PSMA Patients will receive 4 cycles every 8 weeks - 2 weeks
Detailed Description:
Since PSMA radioligand therapy PSMA-RLT demonstrated remarkable therapeutic efficacy in prostate cancer patients the question arises whether PSMA-RLT could also achieve beneficial effects in other cancers expressing PSMA on the tumors cells themselves or in the tumor-associated neovasculature Expression of PSMA was early-on also identified in kidney salivary glands the duodenum and the central and peripheral nervous system Subsequently a wide variety of immunohistochemistry IHC studies showed PSMA to be upregulated on the endothelial cells of the neovasculature of a wide variety of other solid tumors where it may facilitate endothelial cell sprouting and invasion through its regulation of lytic proteases that have the ability to cleave the extracellular matrix Similar to the introduction of PSMA-targeting theranostics in prostate carcinoma overexpression of PSMA on newly formed tumor vessels may serve as a target for imaging and subsequent treatment of cancer through the use of agents that are capable of blocking PSMA in its function or through PSMA-mediated delivery of chemotherapeutics or radiation agents Preclinical data suggests that PSMA might be involved in cancer-related angiogenesis by degrading the extracellular matrix and participating in integrin signal transduction
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