Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470243
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-17
Brief Title:
Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase III Study of Cabazitaxel With or Without Carboplatin in Patients With Metastatic Castrate-Resistant Prostate Cancer mCRPC Stratified by Aggressive Variant Signature
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels castrate-resistant and that has spread from where it first started primary site to other places in the body metastatic Carboplatin is in a class of medications known as platinum-containing compounds Carboplatin works by killing stopping or slowing the growth of tumor cells Chemotherapy drugs such as cabazitaxel work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Prednisone is often given together with chemotherapy drugs Prednisone is in a class of medications called corticosteroids It is used to reduce inflammation and lower the bodys immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I To compare radiographic progression free survival rPFS between the two treatment arms in the subset of aggressive variant prostate cancer - molecular-pathologic signature AVPC-MS-positive participants
II If the AVPC-MS positive test is statistically significant test in AVPC-MS negative participants whether the combination of carboplatin and cabazitaxel improves rPFS
SECONDARY OBJECTIVES
I To compare overall survival OS between the two treatment arms stratified by AVPC-MS positive versus vs negative
II To compare response rates for prostate specific antigen PSA total alkaline phosphatase and Response Evaluation Criteria in Solid Tumors RECIST 11 between the two treatment arms stratified by AVPC-MS positive vs negative
III To compare rPFS between the two treatment arms for the full trial IV To compare rPFS between the two treatment arms for the AVPC-MS negative group in the absence of a positive treatment effect in the AVPC-MS positive group
V To compare progression free survival PFS between the two treatment arms stratified by AVPC-MS positive vs negative
VI To compare toxicities between the two arms in participants who receive any treatment on study
BANKING OBJECTIVES
I To bank specimens for future correlative studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients receive cabazitaxel intravenously IV over 60 minutes on day 1 of each cycle and prednisone orally PO twice daily BID on days 1-21 of each cycle Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity
ARM 2 Patients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity
All patients undergo blood sample collection bone scan computed tomography CT positron emission tomography PET or magnetic resonance imaging MRI throughout the trial and chest radiography x-ray before randomization
After completion of study treatment patients are followed every 12 weeks for 1 year after randomization and then every 26 weeks for up to 4 years after randomization or until death whichever occurs first
I To compare radiographic progression free survival rPFS between the two treatment arms in the subset of aggressive variant prostate cancer - molecular-pathologic signature AVPC-MS-positive participants
II If the AVPC-MS positive test is statistically significant test in AVPC-MS negative participants whether the combination of carboplatin and cabazitaxel improves rPFS
SECONDARY OBJECTIVES
I To compare overall survival OS between the two treatment arms stratified by AVPC-MS positive versus vs negative
II To compare response rates for prostate specific antigen PSA total alkaline phosphatase and Response Evaluation Criteria in Solid Tumors RECIST 11 between the two treatment arms stratified by AVPC-MS positive vs negative
III To compare rPFS between the two treatment arms for the full trial IV To compare rPFS between the two treatment arms for the AVPC-MS negative group in the absence of a positive treatment effect in the AVPC-MS positive group
V To compare progression free survival PFS between the two treatment arms stratified by AVPC-MS positive vs negative
VI To compare toxicities between the two arms in participants who receive any treatment on study
BANKING OBJECTIVES
I To bank specimens for future correlative studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients receive cabazitaxel intravenously IV over 60 minutes on day 1 of each cycle and prednisone orally PO twice daily BID on days 1-21 of each cycle Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity
ARM 2 Patients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity
All patients undergo blood sample collection bone scan computed tomography CT positron emission tomography PET or magnetic resonance imaging MRI throughout the trial and chest radiography x-ray before randomization
After completion of study treatment patients are followed every 12 weeks for 1 year after randomization and then every 26 weeks for up to 4 years after randomization or until death whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04336 | REGISTRY | None | None |
| S2312 | OTHER | None | None |
| S2312 | OTHER | None | None |
| U10CA180888 | NIH | None | None |