Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288113
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-02-05
Brief Title:
Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer RE-LuPSMA Trial
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer A Prospective Phase 2 Trial RE-LuPSMA STUDY
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This phase II trial tests how well re-treatment with 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 that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production castration-resistant and that has shown a favorable response to initial treatment with 177Lu-PSMA-617 177Lu-PSMA-617 is a radioactive drug It binds to a protein called prostate specific membrane antigen PSMA which is expressed by some types of prostate tumor cells When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells it delivers radiation to the cells which may kill them Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer
Detailed Description:
PRIMARY OBJECTIVE
I To assess the treatment efficacy of re-challenge lutetium Lu 177 vipivotide tetraxetan 177Lu-PSMA-617 therapy for a maximum of 6 additional cycles in patients with metastatic castration-resistant prostate cancer mCRPC who had a favorable response to a prior regimen of 177Lu-PSMA-617 therapy
SECONDARY OBJECTIVES
I To determine the safety of re-challenge 177Lu-PSMA-617 therapy by Common Terminology Criteria for Adverse Events CTCAE version 50
II To determine the rate of patients who have a prostate-specific antigen PSA response defined as a PSA decline of 50 during re-challenge 177Lu-PSMA-617 therapy
III To determine biochemical progression-free survival PFS according to Prostate Cancer Working Group 3 PCWG3 guidelines
IV To determine overall survival OS from the start cycle 1 day 1 of the first regimen of 177Lu-PSMA-617 therapy
V To determine OS from the end day 1 of the final cycle of the first regimen of 177Lu-PSMA-617 therapy
VI To determine radiographic progression-free survival rPFS according to Response Evaluation Criteria in PSMA positron emission tomography PETcomputed tomography CT RECIP criteria
VII To determine the impact of re-challenge 177Lu-PSMA-617 therapy on bone pain level health-related quality of life and performance status Eastern Cooperative Oncology Group ECOG using established standardized questionnaires
EXPLORATORY OBJECTIVE
I To determine the dosimetry in organs and tumor lesions of re-challenge 177Lu-PSMA-617 therapy using a 24-hour single-time-point dosimetry protocol
OUTLINE
Patients receive 177Lu-PSMA-617 intravenously IV on day 1 of each cycle Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also receive gallium Ga 68 gozetotide IV and undergo PETCT at screening and on study undergo single photon emission computed tomography SPECTCT on study and undergo collection of blood samples throughout the trial
After completion of study treatment patients are followed up within 8 weeks of their last treatment cycle and then every 3 months for up to a total of 2 years
I To assess the treatment efficacy of re-challenge lutetium Lu 177 vipivotide tetraxetan 177Lu-PSMA-617 therapy for a maximum of 6 additional cycles in patients with metastatic castration-resistant prostate cancer mCRPC who had a favorable response to a prior regimen of 177Lu-PSMA-617 therapy
SECONDARY OBJECTIVES
I To determine the safety of re-challenge 177Lu-PSMA-617 therapy by Common Terminology Criteria for Adverse Events CTCAE version 50
II To determine the rate of patients who have a prostate-specific antigen PSA response defined as a PSA decline of 50 during re-challenge 177Lu-PSMA-617 therapy
III To determine biochemical progression-free survival PFS according to Prostate Cancer Working Group 3 PCWG3 guidelines
IV To determine overall survival OS from the start cycle 1 day 1 of the first regimen of 177Lu-PSMA-617 therapy
V To determine OS from the end day 1 of the final cycle of the first regimen of 177Lu-PSMA-617 therapy
VI To determine radiographic progression-free survival rPFS according to Response Evaluation Criteria in PSMA positron emission tomography PETcomputed tomography CT RECIP criteria
VII To determine the impact of re-challenge 177Lu-PSMA-617 therapy on bone pain level health-related quality of life and performance status Eastern Cooperative Oncology Group ECOG using established standardized questionnaires
EXPLORATORY OBJECTIVE
I To determine the dosimetry in organs and tumor lesions of re-challenge 177Lu-PSMA-617 therapy using a 24-hour single-time-point dosimetry protocol
OUTLINE
Patients receive 177Lu-PSMA-617 intravenously IV on day 1 of each cycle Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also receive gallium Ga 68 gozetotide IV and undergo PETCT at screening and on study undergo single photon emission computed tomography SPECTCT on study and undergo collection of blood samples throughout the trial
After completion of study treatment patients are followed up within 8 weeks of their last treatment cycle and then every 3 months for up to a total of 2 years
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-00310 | REGISTRY | None | None |
| 23-001509 | OTHER | UCLA Jonsson Comprehensive Cancer Center | None |