Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647526
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2020-11-23
Brief Title:
Study Evaluating mCRPC Treatment Using PSMA Lu-177-PNT2002 Therapy After Second-line Hormonal Treatment
Sponsor:
POINT Biopharma a wholly owned subsidiary of Eli Lilly and Company
Organization:
POINT Biopharma a wholly owned subsidiary of Eli Lilly and Company
Study Overview
Official Title:
A Phase 3 Open-Label Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA Lu-177-PNT2002 Therapy After Second-line Hormonal Treatment SPLASH
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
SPLASH
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Lu-177-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy ARAT
Detailed Description:
The primary objective of the study is to determine the efficacy of Lu-177-PNT2002 Lu-177-PSMA-IT versus abiraterone or enzalutamide in delaying radiographic progression in patients with mCRPC
The study consists of 3 phases Dosimetry Randomized Treatment and Long term Follow up
The study will commence with a 25-patient safety and dosimetry lead-in Part 1 and proceed to a randomization treatment phase in approximately 390 patients Part 2 Patients in Part 2 will be randomized in a 21 ratio to receive either Lu-177-PNT2002 Arm A or enzalutamide or abiraterone Arm B Patients in Arm B who experience radiographic progression per central review and meet protocol defined eligibility may crossover to receive Lu-177-PNT2002 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 PET avidity criteria per central review will be eligible for this study
The study consists of 3 phases Dosimetry Randomized Treatment and Long term Follow up
The study will commence with a 25-patient safety and dosimetry lead-in Part 1 and proceed to a randomization treatment phase in approximately 390 patients Part 2 Patients in Part 2 will be randomized in a 21 ratio to receive either Lu-177-PNT2002 Arm A or enzalutamide or abiraterone Arm B Patients in Arm B who experience radiographic progression per central review and meet protocol defined eligibility may crossover to receive Lu-177-PNT2002 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 PET avidity criteria per central review will be eligible for this study
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?:
None
Is an FDA AA801 Violation?:
None