Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05806515
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-03-28
Brief Title:
Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S2210 A Phase II Study of Neoadjuvant Carboplatin for Localized High Risk Prostate Cancer With Germline BRCA12 Mutations
Status:
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:
This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation Carboplatin is in a class of medications known as platinum-containing compounds It works in a way similar to the anticancer drug cisplatin but may be better tolerated than cisplatin Carboplatin works by killing stopping or slowing the growth of tumor cells Giving carboplatin before surgery may shrink tumors in patients with high-risk prostate cancer with BRCA1 and BRCA2 gene mutations
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents
SECONDARY OBJECTIVES
I To evaluate prostate specific antigen PSA progression-free survival post-prostatectomy over the duration of follow-up and specifically at the 3-year landmark
II To evaluate metastases free survival and overall survival III To evaluate the frequency and severity of toxicities of neoadjuvant carboplatin followed by radical prostatectomy
BANKING OBJECTIVE
I To bank specimens for future correlative studies
OUTLINE
Patients receive carboplatin intravenously IV on study Patients then undergo surgery on study Patients who experience PSA progression after surgery undergo computed tomography CT or magnetic resonance imaging MRI of the abdomen and pelvis CT of the chest or chest X-ray or prostate-specific membrane antigen PSMA-positron emission tomography PET throughout the trial Patients also undergo collection of blood samples throughout the trial
I To evaluate the pathologic complete response rate at prostatectomy in patients with localized high-risk prostate cancer with germline BRCA2 or BRCA1 mutations who are treated with neoadjuvant carboplatin by central review of source documents
SECONDARY OBJECTIVES
I To evaluate prostate specific antigen PSA progression-free survival post-prostatectomy over the duration of follow-up and specifically at the 3-year landmark
II To evaluate metastases free survival and overall survival III To evaluate the frequency and severity of toxicities of neoadjuvant carboplatin followed by radical prostatectomy
BANKING OBJECTIVE
I To bank specimens for future correlative studies
OUTLINE
Patients receive carboplatin intravenously IV on study Patients then undergo surgery on study Patients who experience PSA progression after surgery undergo computed tomography CT or magnetic resonance imaging MRI of the abdomen and pelvis CT of the chest or chest X-ray or prostate-specific membrane antigen PSMA-positron emission tomography PET throughout the trial Patients also undergo collection of blood samples throughout the trial
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 |
|---|---|---|---|
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |
| NCI-2023-02356 | REGISTRY | None | None |
| S2210 | OTHER | None | None |
| S2210 | OTHER | None | None |