Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526299
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Low PSMA SUV Boost LPS-Boost Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of Biomarker-Modulated PSMA Theranostics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started primary site to other places in the body metastatic and that remains despite treatment resistant Lutetium Lu 177 177Lu the radioactive tracer component being delivered by prostate-specific membrane antigen PSMA-617 has physical properties that make it ideal radionuclide imaging tests that uses a small dose tracer for treatment of metastatic castrate-resistant prostate cancer mCRPC 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid DNA inside prostate cancer cells Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC
Detailed Description:
OUTLINE
Patients receive 177Lu-PSMA-617 intravenously IV over 30 minutes on days 1 8 50 57 99 and 141 Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle 2 and subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo PSMA positron emission tomographycomputed tomography PETCT during screening and single photon emission computed tomography SPECTCT on study Patients also undergo CT or magnetic resonance imaging MRI bone scan as well as blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days and then every 12 weeks for up to 2 years
Patients receive 177Lu-PSMA-617 intravenously IV over 30 minutes on days 1 8 50 57 99 and 141 Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle 2 and subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo PSMA positron emission tomographycomputed tomography PETCT during screening and single photon emission computed tomography SPECTCT on study Patients also undergo CT or magnetic resonance imaging MRI bone scan as well as blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days and then every 12 weeks for up to 2 years
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