Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496581
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Standard of Care - 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response PEACE6-Poor Responders
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
A Randomized Phase III Trial Evaluating the Efficacy and Safety of Standard of Care - 177Lu-PSMA617 in de Novo Metastatic Hormone-sensitive Prostate Cancer Patients Having a PSA02 ngmL at 6-8 Months After Systemic Treatment Initiation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
PEACE-6 Poor Responders is an international multicenter open-label controlled randomized phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when administered on top of the ongoing standard systemic treatment compared to standard systemic treatment alone in patients with de novo metastatic hormone-sensitive prostate cancer mHSPC who do not present with a satisfactory response characterized by a serum prostatic specific antigen PSA level of 02 ngmL at 6 to 8 months after systemic treatment initiation for mHSPC ie poor responders in the absence of evidence of cancer progression including a rising PSA level
Detailed Description:
The study plans to enroll 500 patients over 63 months who will be randomized 11 to receive either i Control arm SoC ADT ARSI second-generation androgen receptor signaling inhibitors - RT or ADT ARSI - RT or ii Experimental arm 177Lu-PSMA-617 SoC ADT ARSI - RT or ADT docetaxel ARSI - RT Response to treatment will be assessed according to the Prostate Cancer Clinical Trials Working Group 3 PCWG3 criteria Treatment will be continued at least until castration-resistant prostate cancer CRPC stage is reached defined by evidence of cancer progression either a confirmed PSA rise or a radiographic progression with serum testosterone being at castrated levels 050 ngmL This systemic treatment may be continued after CRPC is reached based on patient benefit and the investigators opinion Treatment may also be terminated at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient including unacceptable toxicity intercurrent conditions that preclude continuation of treatment or patient request At the end of treatment period the follow-up period will last for 102 months 85 years The overall trial duration including the follow-up is expected to last 185 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502408-57-00 | CTIS | None | None |