Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592924
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Docetaxel and Hormone Treatment Compared to Hormone Treatment Alone in People With Metastatic Castration Sensitive Prostate Cancer and Less Than Optimal PSA Response
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response
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:
TRIPLE-SWITCH
Brief Summary:
This study is being done to answer the following question can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI
Detailed Description:
This is an international multi-centre open-label randomized phase III trial comparing Docetaxel chemotherapy added to standard of care Androgen Deprivation Therapy ADT Androgen-Receptor Pathway Inhibitor ARPI versus standard of care Androgen Deprivation Therapy ADT Androgen-Receptor Pathway Inhibitor ARPI in participants with metastatic castration sensitive prostate cancer mCSPC who have a suboptimal PSA response after 6-12 months of androgen-targeting therapy
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