Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-19
Brief Title:
Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
Official Title:
A Randomized Phase III Study of Neoadjuvant Treatment With 177-Lutetium- PSMA-617 With or Without Ipilimumab in Subjects With Very High-risk Prostate Cancer Who Are Candidates for Radical Prostatectomy NEPI Trial
Status:
NOT_YET_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:
NEPI
Brief Summary:
A randomized open-label Phase III study of neoadjuvant treatment with 177LuLu-PSMA-617 radioligandtherapy LuPSMA with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy
Detailed Description:
A randomized open-label Phase III study of neoadjuvant treatment with 177LuLu-PSMA-617 radioligandtherapy LuPSMA with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy
The study will be initiated by a safety cohort regarding the 177LuLu- PSMA-617 dose including 6 to 12 patients who will receive combination therapy with 177LuLu-PSMA-617 and Ipilimumab The Safety-Run-In-Phase follows a none of three or one of six patients experienced intolerable events approach per dose level That is The first 3 patients will receive 4 courses of ipilimumab 3 mgkg and 2 courses of 37 GBq 177LuLu-PSMA-617 If no more than one of these patients develop grade 4 adverse reactions ARs without recovery within 3 weeks another 3 patients will receive the same dosage If no grade 4 AEs are observed in this second set of patients we will enroll an additional 3 patients to increase the 177LuLuPSMA 617 dose to 74 GBq If no more than one of those patients develop grade 4 ARs without recovery within 3 weeks back to grade 1 or to baseline values another 3 patients will receive the same increased dosage Provided that these patients do not develop grade 4 ARs randomization of patients will be started If the none of three or one of six patients experienced intolerable events approach per dose level is not passed the study will be terminated at this point
46 patients with newly diagnosed very high-risk prostate cancer will be randomly assigned in a 11 ratio Ipilimumab 177LuLu-PSMA- 617 vs 177LuLu-PSMA-617 alone to receive 2 cycles of 74 GBq 177LuLu-PSMA-617 with or without 4 cycles of concomitant Ipilimumab 3mgkg prior to prostatectomy Radioligandtherapy will be given at 6 weeks intervals while ipilimumab will be given every 3 weeks For application of ipilimumab and 177LuLu-PSMA-617 within one cycle week 1 and 7 177LuLu-PSMA-617 is administered on day 1 and ipilimumab on day 3 ADT will be applied to all patients during the neoadjuvant treatment phase
The study will be initiated by a safety cohort regarding the 177LuLu- PSMA-617 dose including 6 to 12 patients who will receive combination therapy with 177LuLu-PSMA-617 and Ipilimumab The Safety-Run-In-Phase follows a none of three or one of six patients experienced intolerable events approach per dose level That is The first 3 patients will receive 4 courses of ipilimumab 3 mgkg and 2 courses of 37 GBq 177LuLu-PSMA-617 If no more than one of these patients develop grade 4 adverse reactions ARs without recovery within 3 weeks another 3 patients will receive the same dosage If no grade 4 AEs are observed in this second set of patients we will enroll an additional 3 patients to increase the 177LuLuPSMA 617 dose to 74 GBq If no more than one of those patients develop grade 4 ARs without recovery within 3 weeks back to grade 1 or to baseline values another 3 patients will receive the same increased dosage Provided that these patients do not develop grade 4 ARs randomization of patients will be started If the none of three or one of six patients experienced intolerable events approach per dose level is not passed the study will be terminated at this point
46 patients with newly diagnosed very high-risk prostate cancer will be randomly assigned in a 11 ratio Ipilimumab 177LuLu-PSMA- 617 vs 177LuLu-PSMA-617 alone to receive 2 cycles of 74 GBq 177LuLu-PSMA-617 with or without 4 cycles of concomitant Ipilimumab 3mgkg prior to prostatectomy Radioligandtherapy will be given at 6 weeks intervals while ipilimumab will be given every 3 weeks For application of ipilimumab and 177LuLu-PSMA-617 within one cycle week 1 and 7 177LuLu-PSMA-617 is administered on day 1 and ipilimumab on day 3 ADT will be applied to all patients during the neoadjuvant treatment phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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