Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625970
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Phase III Trial With a Factorial Design Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse From the Prostate Cancer Consortium in Europe PEACE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
PEACE 7
Brief Summary:
PEACE 7 is an international multicenter randomized open-label phase III study that aims at evaluating the efficacy and safety of darolutamide and of stereotactic dose escalated prostate radiotherapy in patients with localised prostate cancer and high-risk features of relapse defined as patients with at least 2 high-risk criteria from National Comprehensive Cancer Network NCCN classification using a factorial 2x2 design
The primary objective of this study is to assess the efficacy of darolutamide and of a stereotactic dose escalated radiotherapy targeting prostate in combination with ADT and pelvic nodal radiotherapy in terms of metastasis-free survival MSF
Patients will be randomized 1111 to receive either
Arm A Standard arm ADT conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy
Arm B Experimental arm ADT conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy darolutamide
Arm C Experimental arm ADT conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy Prostate SBRT
Arm D Experimental arm ADT conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy Prostate SBRT darolutamide
Patient will receive systemic treatments ADT andor darolutamide during 2 years where visits on site are planned at D45 D90 D180 and then every 3 months for checkups and follow prostate specific antigen PSA level
Metastasis-free survival MFS is defined as the time interval from randomization to the date of the appearance of metastasis on next generation imaging or death from any cause whichever occurs first Radiographic evaluation will be carried out at the time of biochemical failure Phoenix criteria or in case of clinical suspicion After biochemical failure Phoenix criteria radiographic evaluation on next generation imaging prostate-specific membrane antigen PSMA positron emission tomography PET scan any European Medicines Agency EMA approved PSMA tracer will be performed every 6 months until a metastatic site of relapse is identified and will be repeated at each subsequent PSA progression
The primary objective of this study is to assess the efficacy of darolutamide and of a stereotactic dose escalated radiotherapy targeting prostate in combination with ADT and pelvic nodal radiotherapy in terms of metastasis-free survival MSF
Patients will be randomized 1111 to receive either
Arm A Standard arm ADT conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy
Arm B Experimental arm ADT conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy darolutamide
Arm C Experimental arm ADT conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy Prostate SBRT
Arm D Experimental arm ADT conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy Prostate SBRT darolutamide
Patient will receive systemic treatments ADT andor darolutamide during 2 years where visits on site are planned at D45 D90 D180 and then every 3 months for checkups and follow prostate specific antigen PSA level
Metastasis-free survival MFS is defined as the time interval from randomization to the date of the appearance of metastasis on next generation imaging or death from any cause whichever occurs first Radiographic evaluation will be carried out at the time of biochemical failure Phoenix criteria or in case of clinical suspicion After biochemical failure Phoenix criteria radiographic evaluation on next generation imaging prostate-specific membrane antigen PSMA positron emission tomography PET scan any European Medicines Agency EMA approved PSMA tracer will be performed every 6 months until a metastatic site of relapse is identified and will be repeated at each subsequent PSA progression
Detailed Description:
None
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