Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594926
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-23
Brief Title:
Working Out M0 Bipolar Androgen Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Efficacy of Bipolar Androgen Therapy in Extending Metastasis-free Survival in Patients With M0 Castrate-resistant Prostate Cancer With PSA Progression But Not Radiological or Clinical Progression on Darolutamide
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WOMBAT
Brief Summary:
The WOMBAT study will test if BAT can prolong the time it takes for nmCRPC prostate cancer to become detectable in other areas of the body metastatic disease
Approximately 69 participants over the age of 18 with castrate resistant prostate cancer no evidence of metastatic disease M0 on conventional imaging WBBS and CT scan at screening and PSA only progression on darolutamide will be enrolled from approximately 8 sites within Australia
Participants will receive continuous androgen deprivation therapy with LHRH agonistsantagonists The study intervention will be IM testosterone enthanate injected on day 1 of each 56-day cycle Concurrent darolutamide will be taken at a dose of 600mg BD on days 29-56 of each cycle Both LHRH and agonistantagonist and darolutamide are supplied through the PBS as standard of care medications Administration of both testosterone and darolutamide will continue until disease progression beyond disease progression unacceptable toxicity death withdrawal of consent or study Sponsor termination of the study
Primary objective endpoint is to determine the metastasis-free survival time from commencing BAT to evidence of metastases or death
Approximately 69 participants over the age of 18 with castrate resistant prostate cancer no evidence of metastatic disease M0 on conventional imaging WBBS and CT scan at screening and PSA only progression on darolutamide will be enrolled from approximately 8 sites within Australia
Participants will receive continuous androgen deprivation therapy with LHRH agonistsantagonists The study intervention will be IM testosterone enthanate injected on day 1 of each 56-day cycle Concurrent darolutamide will be taken at a dose of 600mg BD on days 29-56 of each cycle Both LHRH and agonistantagonist and darolutamide are supplied through the PBS as standard of care medications Administration of both testosterone and darolutamide will continue until disease progression beyond disease progression unacceptable toxicity death withdrawal of consent or study Sponsor termination of the study
Primary objective endpoint is to determine the metastasis-free survival time from commencing BAT to evidence of metastases or death
Detailed Description:
This is a study to assess the efficacy and safety of cyclical testosterone and darolutamide in non-metastatic castration-resistant prostate cancer
Adults with castrate resistant prostate cancer with no evidence of metastatic disease M0 on conventional imaging Whole Body Bone Scan WBBS and Computed Tomography CT scan at screening and prostate specific antigen PSA only progression on darolutamide may be eligible
Study participants will receive cyclical treatment with intramuscular IM testosterone darolutamide and ongoing medicalsurgical castration This will be delivered in 56-day cycles until evidence of metastatic disease on conventional imaging unless treated beyond progression Participants will be asked to provide blood samples complete questionnaires and undergo scans during their treatment
It is hoped that findings from this study will help develop new treatment pathways for those with non-metastatic castration-resistant prostate cancer
Adults with castrate resistant prostate cancer with no evidence of metastatic disease M0 on conventional imaging Whole Body Bone Scan WBBS and Computed Tomography CT scan at screening and prostate specific antigen PSA only progression on darolutamide may be eligible
Study participants will receive cyclical treatment with intramuscular IM testosterone darolutamide and ongoing medicalsurgical castration This will be delivered in 56-day cycles until evidence of metastatic disease on conventional imaging unless treated beyond progression Participants will be asked to provide blood samples complete questionnaires and undergo scans during their treatment
It is hoped that findings from this study will help develop new treatment pathways for those with non-metastatic castration-resistant prostate cancer
Study Oversight
Has Oversight DMC:
None
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?:
None