Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305598
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-03-05
Brief Title:
Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer mCRPC
Status:
RECRUITING
Status Verified Date:
2024-09
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 I trial tests the change in androgen receptor sensitivity side effects and effectiveness of bipolar androgen therapy using testosterone in patients with castration resistant prostate cancer that has spread to other places is the body metastatic Bipolar androgen therapy is the regulation of testosterone between castration levels lower than what would be normally present and supraphysiological levels amounts greater than normally found in the body This may suppress cancer cell growth which reduces prostate-specific antigen PSA levels and may delay cancer progression
Detailed Description:
PRIMARY OBJECTIVE
I To determine the influence of bipolar androgen therapy BAT on androgen receptor AR activity in patients with metastatic castration-resistant prostate cancer mCRPC
SECONDARY OBJECTIVES
To determine the clinical efficacy and safety of BAT in patients with mCRPC
To determine the change in fatigue and quality of life in patients receiving BAT
OUTLINE
Patients receive testosterone intramuscularly IM on day 1 of each cycle Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity Patients also continue to receive standard of care leuprolide acetate subcutaneously SC per their standard schedule Patients undergo computed tomography CT scan bone scan and may undergo magnetic resonance imaging and tumor biopsy throughout the study
After completion of study treatment patients follow up at 30 days and every 3 months for up to 2 years
I To determine the influence of bipolar androgen therapy BAT on androgen receptor AR activity in patients with metastatic castration-resistant prostate cancer mCRPC
SECONDARY OBJECTIVES
To determine the clinical efficacy and safety of BAT in patients with mCRPC
To determine the change in fatigue and quality of life in patients receiving BAT
OUTLINE
Patients receive testosterone intramuscularly IM on day 1 of each cycle Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity Patients also continue to receive standard of care leuprolide acetate subcutaneously SC per their standard schedule Patients undergo computed tomography CT scan bone scan and may undergo magnetic resonance imaging and tumor biopsy throughout the study
After completion of study treatment patients follow up at 30 days and every 3 months for up to 2 years
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 |
|---|---|---|---|
| I-3298823 | OTHER | Roswell Park Cancer Institute | None |
| NCI-2024-01390 | REGISTRY | None | None |