Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582628
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Talazoparib Plus Enzalutamide After Progression to Abiraterone in Metastatic Prostate Cancer TEAM PC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Open Label Randomized Phase II Trial to Evaluate the Efficacy of Talazoparib Plus Enzalutamide as First Line Treatment for Patients With Metastatic Castration Resistant Prostate Cancer Following Progression on Abiraterone
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TEAM PC
Brief Summary:
The purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer mCRPC in participants whose disease has progressed on abiraterone
The main questions it aims to answer are
Does talazoparib plus enzalutamide improve efficacy in metastatic castration resistant prostate cancer mCRPC compared to enzalutamide alone
What is the time to disease progression radiographic Prostate Specific Antigen PSA clinical in participants treated with talazoparib plus enzalutamide after progression on abiraterone
What medical problems do participants have when receiving talazoparib plus enzalutamide
Researchers will compare the combination of talazoparib and enzalutamide as a first-line treatment for mCRPC to see if the combination improves the PSA response rate and delays progression compared to enzalutamide alone The safety and tolerability of the combination talazoparib and enzalutamide will also be studied
The main questions it aims to answer are
Does talazoparib plus enzalutamide improve efficacy in metastatic castration resistant prostate cancer mCRPC compared to enzalutamide alone
What is the time to disease progression radiographic Prostate Specific Antigen PSA clinical in participants treated with talazoparib plus enzalutamide after progression on abiraterone
What medical problems do participants have when receiving talazoparib plus enzalutamide
Researchers will compare the combination of talazoparib and enzalutamide as a first-line treatment for mCRPC to see if the combination improves the PSA response rate and delays progression compared to enzalutamide alone The safety and tolerability of the combination talazoparib and enzalutamide will also be studied
Detailed Description:
This is a multicenter open-label randomized phase II trial to evaluate the efficacy of the combination of talazoparib plus enzalutamide versus enzalutamide as first line treatment for metastatic castration resistant prostate cancer mCRPC in participants whose disease has progressed to abiraterone based treatment for metastatic hormone sensitive prostate cancer mHSPC Participants who meet the eligibility criteria will be randomized 11 to the experimental arm enzalutamide and talazoparib or control arm enzalutamide and will receive treatment until disease progression unacceptable toxicity death or discontinuation from the study treatment for any other reason
Prostate cancer is the second most common malignancy in men worldwide with an estimated annual global incidence of 13 million and over 375000 deaths Aggressive variant prostate cancer is a clinically defined subset of metastatic castration resistant prostate cancers mCRPC characterized by the absence of response to androgen receptor AR targeted agents and neuroendocrine features The treatments that are currently available are not effective representing an unmet clinical need The combination of talazoparib a potent selective PARP inhibitor PARPi and enzalutamide androgen receptor signaling inhibitor ARSi demonstrated in the TALAPRO-2 study improved efficacy in metastatic castration resistant prostate cancer mCRPC participants with and without DNA damage response DDR gene alterations as first line treatment 1L compared to enzalutamide alone
Up to 78 participants will be enrolled and randomized 11 to the experimental and control armsUp to 19 participants will be allocated into the experimental arm in Stage 1 An interim analysis will be triggered once each patient on the experimental arm has been followed up for at least 16 weeks or earlier if response status can be ascertained definitively to decide whether to proceed to Stage 2 or discontinue the study If greater than or equal to 6 responses are observed recruitment will continue to Stage 2 enrolling 20 more participants on each arm otherwise the trial will stop
Estimated duration of the study 36 months Accrual is expected to be completed in 18 months Median treatment duration has been estimated in 10 months After completion of or discontinuation from treatment participants will be followed up for survival until end of study EoS that will occur at 18 months after the enrollment of the last patient included in the trial unless premature termination of the study
It is hypothesized that after progression to abiraterone the addition of talazoparib to enzalutamide as 1L for mCRPC will result in improved PSA response rate and delayed progression compared to enzalutamide alone
Prostate cancer is the second most common malignancy in men worldwide with an estimated annual global incidence of 13 million and over 375000 deaths Aggressive variant prostate cancer is a clinically defined subset of metastatic castration resistant prostate cancers mCRPC characterized by the absence of response to androgen receptor AR targeted agents and neuroendocrine features The treatments that are currently available are not effective representing an unmet clinical need The combination of talazoparib a potent selective PARP inhibitor PARPi and enzalutamide androgen receptor signaling inhibitor ARSi demonstrated in the TALAPRO-2 study improved efficacy in metastatic castration resistant prostate cancer mCRPC participants with and without DNA damage response DDR gene alterations as first line treatment 1L compared to enzalutamide alone
Up to 78 participants will be enrolled and randomized 11 to the experimental and control armsUp to 19 participants will be allocated into the experimental arm in Stage 1 An interim analysis will be triggered once each patient on the experimental arm has been followed up for at least 16 weeks or earlier if response status can be ascertained definitively to decide whether to proceed to Stage 2 or discontinue the study If greater than or equal to 6 responses are observed recruitment will continue to Stage 2 enrolling 20 more participants on each arm otherwise the trial will stop
Estimated duration of the study 36 months Accrual is expected to be completed in 18 months Median treatment duration has been estimated in 10 months After completion of or discontinuation from treatment participants will be followed up for survival until end of study EoS that will occur at 18 months after the enrollment of the last patient included in the trial unless premature termination of the study
It is hypothesized that after progression to abiraterone the addition of talazoparib to enzalutamide as 1L for mCRPC will result in improved PSA response rate and delayed progression compared to enzalutamide alone
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