Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-27 @ 7:03 PM
Study NCT ID:
NCT06738303
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2024-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Carboplatin and Cabazitaxel Versus 177Lu-PSMA-617 in Patients With Aggressive, Metastatic Castrate-resistant Prostate Cancer (CATCH-177)
Status:
RECRUITING
Status Verified Date:
2025-08
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:
CATCH-177
Brief Summary:
The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.
Detailed Description:
Brief Background/Rationale
Metastatic prostate cancer initially is very responsive to androgen deprivation therapy (ADT), with intensification using an androgen receptor pathway inhibitor (ARPI) such as abiraterone acetate, enzalutamide, apalutamide, or darolutamide with or without docetaxel to prolong sensitivity to treatment and overall survival. Over time, however, prostate cancer transitions from castrate-sensitive to castrate-resistant. Metastatic castrate-resistant prostate cancer (mCRPC) has a dismal prognosis, with a median survival of under three years. There are now several agents with diverse mechanisms of action approved for use in mCRPC including cabazitaxel, sipuleucel-T, abiraterone acetate, enzalutamide, radium-223, olaparib, rucaparib, and 177Lu-PSMA-617.
Despite the treatment advances in the past decade, many cases of mCRPC either do not respond to these treatments or only respond for a short period of time. Predictive biomarkers are needed. In addition, with several options available, it is not always clear the optimal sequencing of these agents.
Metastatic prostate cancer initially is very responsive to androgen deprivation therapy (ADT), with intensification using an androgen receptor pathway inhibitor (ARPI) such as abiraterone acetate, enzalutamide, apalutamide, or darolutamide with or without docetaxel to prolong sensitivity to treatment and overall survival. Over time, however, prostate cancer transitions from castrate-sensitive to castrate-resistant. Metastatic castrate-resistant prostate cancer (mCRPC) has a dismal prognosis, with a median survival of under three years. There are now several agents with diverse mechanisms of action approved for use in mCRPC including cabazitaxel, sipuleucel-T, abiraterone acetate, enzalutamide, radium-223, olaparib, rucaparib, and 177Lu-PSMA-617.
Despite the treatment advances in the past decade, many cases of mCRPC either do not respond to these treatments or only respond for a short period of time. Predictive biomarkers are needed. In addition, with several options available, it is not always clear the optimal sequencing of these agents.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: