Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520345
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC ProstACT-GLOBAL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multinational Multicenter Prospective Randomized Controlled Open-Label Phase 3 Study of Lutetium 177Lu Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment
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:
The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment
Detailed Description:
The primary objective of the study is to compare radiographic progression-free survival rPFS in participants who receive 177Lu-TLX591 with SOC to rPFS in participants who receive SOC only
This study consists of three Parts
Part 1 Safety and Dosimetry Lead-in
Part 2 Randomized Treatment Expansion and
Part 3 Long-term Follow-up
The study will commence with a 30-patient safety and dosimetry lead-in Part 1 and proceed to a randomization treatment expansion in approximately 400 patients Part 2
Patients in Part 2 will be randomized in a 21 ratio to receive either 177Lu-TLX591 Standard of Care SoC Group A or SoC alone Arm B
SoC in this trial is either ARPI enzalutamide or abiraterone or docetaxel
All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose death or loss to follow up Part 3
Only patients that meet PSMA-positivity criteria per Blinded Independent Central Review BICR will be eligible for this study
This study consists of three Parts
Part 1 Safety and Dosimetry Lead-in
Part 2 Randomized Treatment Expansion and
Part 3 Long-term Follow-up
The study will commence with a 30-patient safety and dosimetry lead-in Part 1 and proceed to a randomization treatment expansion in approximately 400 patients Part 2
Patients in Part 2 will be randomized in a 21 ratio to receive either 177Lu-TLX591 Standard of Care SoC Group A or SoC alone Arm B
SoC in this trial is either ARPI enzalutamide or abiraterone or docetaxel
All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose death or loss to follow up Part 3
Only patients that meet PSMA-positivity criteria per Blinded Independent Central Review BICR will be eligible for this study
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