Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-27 @ 1:07 AM
Study NCT ID:
NCT03002220
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2016-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Rad-223 Activity in Asymptomatic Patients With mCRPC While on Abiraterone or Enzalutamide Besides AR-V7 Status
Sponsor:
MedSIR
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial of Radium-223 Activity in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) With Asymptomatic Progression While on Abiraterone Acetate or Enzalutamide Besides AR-V7 Mutational Status
Status:
COMPLETED
Status Verified Date:
2024-10
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:
EXCAAPE
Brief Summary:
Radium-223 is indicated for the treatment of patients with mCRPC with symptomatic bone metastases and no known visceral metastatic disease. However, very few data have been reported in patients with mCRPC who are asymptomatic or mildly symptomatic. Recently, results from an International Expanded Access Program have also suggested a benefit of radium-223 in asymptomatic patients with mCRPC. In addition, the mechanism of action of radium-223 should not be correlated with the presence/absence of the AR-V7 mutation, although this issue has not yet been evaluated.
The aim of this study is to assess the efficacy of radium-223 in asymptomatic patients with mCRPC, and to establish the association between AR-V7 status and radium-223 activity.
The aim of this study is to assess the efficacy of radium-223 in asymptomatic patients with mCRPC, and to establish the association between AR-V7 status and radium-223 activity.
Detailed Description:
Primary objective:
To assess the efficacy of radium-223 in asymptomatic patients with mCRPC who have progressed while on abiraterone acetate or enzalutamide treatment.
Primary endpoint:
To determine the efficacy of radium-223 in terms of radiological rPFS.
Secondary objectives:
* Safety profile.
* To determine the association between AR-V7 status (positive vs. negative) and PFS.
* To establish the relationship between CTCs number with radium-223 efficacy.
Secondary endpoints:
Safety AEs will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) of the US National Cancer Institute (NCI) version 4.0 \[20\]. Grade 3 or 4 AEs and serious adverse events (SAEs) will be assessed to determine the safety and tolerability of the various combinations of drugs.
Efficacy
* Radiographic progression-free survival (rPFS) depending on AR-V7 status.
* Overall survival (OS).
* Time to first symptomatic skeletal event (SSE).
* Time to prostate specific antigen (PSA) progression according to the Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) study criteria.
* Determination percentage of PSA progression.
* Alkaline phosphatase level response (AF), normalization of alkaline phosphatase level, according to the ALSYMPCA study criteria.
Molecular aspects
* Assessment of AR-V7 mutation evolution during the study treatment.
* Determination changes in CTCs number during the study treatment.
To assess the efficacy of radium-223 in asymptomatic patients with mCRPC who have progressed while on abiraterone acetate or enzalutamide treatment.
Primary endpoint:
To determine the efficacy of radium-223 in terms of radiological rPFS.
Secondary objectives:
* Safety profile.
* To determine the association between AR-V7 status (positive vs. negative) and PFS.
* To establish the relationship between CTCs number with radium-223 efficacy.
Secondary endpoints:
Safety AEs will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) of the US National Cancer Institute (NCI) version 4.0 \[20\]. Grade 3 or 4 AEs and serious adverse events (SAEs) will be assessed to determine the safety and tolerability of the various combinations of drugs.
Efficacy
* Radiographic progression-free survival (rPFS) depending on AR-V7 status.
* Overall survival (OS).
* Time to first symptomatic skeletal event (SSE).
* Time to prostate specific antigen (PSA) progression according to the Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) study criteria.
* Determination percentage of PSA progression.
* Alkaline phosphatase level response (AF), normalization of alkaline phosphatase level, according to the ALSYMPCA study criteria.
Molecular aspects
* Assessment of AR-V7 mutation evolution during the study treatment.
* Determination changes in CTCs number during the study treatment.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-001888-36 | EUDRACT_NUMBER | None | View |