Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-28 @ 5:56 AM
Study NCT ID:
NCT04558866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)
Sponsor:
Latin American Cooperative Oncology Group
Organization:
Study Overview
Official Title:
Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
ExBAT
Brief Summary:
This is a multi-center, open-label, phase II, single-arm trial evaluating combination of darolutamide and high testosterone doses - extreme bipolar androgen therapy (ExBAT) - in patients with metastatic castration-resistant prostate cancer (mCRPC).
Detailed Description:
This is a multi-center, open-label, phase II, single-arm trial evaluating combination of darolutamide and high testosterone doses - extreme bipolar androgen therapy (ExBAT) - in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after abiraterone. Extreme androgen therapy will include alternating 56-day cycles of darolutamide 1,200mg/day (two 300 tablets every 12 hours) p.o. for 28 days followed by testosterone cypionate 400 mg i.m. During the treatment period, patients will be followed with chest, abdomen and pelvis CT and bone scan every 8-9 weeks until cycle 4 and every 12 weeks thereafter during the study period. Patients who present with disease progression but are considered to be benefiting from the treatment may continue receiving it, but will be followed by their treating physician according to local guidelines (follow-up period). All patients who stopped treatment will enter follow-up period and survival data will be collected from medical charts. Additionally, QoL questionnaires (BPI-SF, EQ-5D-3L and FACT-P) will be applied every 8-9 weeks until the end of treatment.
Study Oversight
Has Oversight DMC:
False
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?: