Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216249
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-11-30
Brief Title:
Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer FLEX-MRT
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase 2 Randomized Trial in Patients With Metastatic Castration Resistant Prostate Cancer to Determine the Efficacy of a Flexible Dosing Schedule of Lu-PSMA Treatment up to 12 Cycles Including Potential Treatment Holiday Periods in Comparison to the Standard Fixed Dosing Schedule of Six Cycles Every Six Weeks FLEX-MRT
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:
The randomized phase 2 FLEX MRT compares a group of patients treated with LuPSMA on a flexible and extended dosing schedule including treatment holiday periods investigational arm up to 12 cycles to a control group treated with a fixed dosing schedule of 6 treatments cycles maximum administered every 6 weeks
The flexible dosing schedule in the investigational arm will be based on SPECTCT response assessments obtained 24h after injection of LuPSMA therapy cycle The response assessment during treatment holiday period will be based on PETCT every 12 weeks
The flexible dosing schedule in the investigational arm will be based on SPECTCT response assessments obtained 24h after injection of LuPSMA therapy cycle The response assessment during treatment holiday period will be based on PETCT every 12 weeks
Detailed Description:
PRIMARY OBJECTIVE
I To assess a potential survival benefit 2-year survival rate of patients treated with Lu 177 vipivotide tetraxetan 177Lu-PSMA-617 therapy on a flexible dosing schedule including up to 12 cycles and potential treatment holiday periods in comparison to patients treated with the standard fixed dosing schedule of maximum 6 treatment cycles every 6 weeks
SECONDARY OBJECTIVES
I To determine the safety of the flexibleextended schedule of 177Lu-PSMA-617 therapy
II To compare the overall survival OS of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
III To compare the progression-free survival PFS of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
IV To compare the disease control rate DCR of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
V To compare the impact on bone pain level of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
VI To compare the impact on health-related quality of life of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
EXPLORATORY OBJECTIVE
I To determine the dosimetry in organs and tumor lesions of the flexibleextended schedule of 177Lu-PSMA-617 therapy
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive 177Lu-PSMA-617 intravenously IV once every 6 weeks on study Beginning with the third cycle treatments may be postponed beyond the 6 weeks interval based on defined response criteria treatment holiday period Treatment repeats every 6 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity Patients receive gallium Ga 68 gozetotide 68Ga-PSMA-11 IV and undergo prostate-specific membrane antigen positron emission tomographycomputed tomography PSMA PETCT throughout the trial Patients also undergo single photon emission computed tomography SPECTCT PETCT or CT on the trial
ARM II Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study Treatment repeats every 6 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity Patients receive 68Ga-PSMA-11 IV and undergo PSMA PETCT throughout the trial Patients also undergo SPECTCT PETCT or CT on the trial
Upon completion of study treatment patients are followed up every 3 months for 24 months from after first cycle of study treatment
I To assess a potential survival benefit 2-year survival rate of patients treated with Lu 177 vipivotide tetraxetan 177Lu-PSMA-617 therapy on a flexible dosing schedule including up to 12 cycles and potential treatment holiday periods in comparison to patients treated with the standard fixed dosing schedule of maximum 6 treatment cycles every 6 weeks
SECONDARY OBJECTIVES
I To determine the safety of the flexibleextended schedule of 177Lu-PSMA-617 therapy
II To compare the overall survival OS of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
III To compare the progression-free survival PFS of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
IV To compare the disease control rate DCR of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
V To compare the impact on bone pain level of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
VI To compare the impact on health-related quality of life of the flexibleextended schedule of 177Lu-PSMA-617 therapy to the standard-of-care schedule of 177Lu-PSMA-617 therapy
EXPLORATORY OBJECTIVE
I To determine the dosimetry in organs and tumor lesions of the flexibleextended schedule of 177Lu-PSMA-617 therapy
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive 177Lu-PSMA-617 intravenously IV once every 6 weeks on study Beginning with the third cycle treatments may be postponed beyond the 6 weeks interval based on defined response criteria treatment holiday period Treatment repeats every 6 weeks for 12 cycles in the absence of disease progression or unacceptable toxicity Patients receive gallium Ga 68 gozetotide 68Ga-PSMA-11 IV and undergo prostate-specific membrane antigen positron emission tomographycomputed tomography PSMA PETCT throughout the trial Patients also undergo single photon emission computed tomography SPECTCT PETCT or CT on the trial
ARM II Patients receive 177Lu-PSMA-617 IV once every 6 weeks on study Treatment repeats every 6 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity Patients receive 68Ga-PSMA-11 IV and undergo PSMA PETCT throughout the trial Patients also undergo SPECTCT PETCT or CT on the trial
Upon completion of study treatment patients are followed up every 3 months for 24 months from after first cycle of study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
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-2023-07172 | REGISTRY | CTRP Clinical Trial Reporting Program | None |