Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate
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|ClinicalTrials.gov Identifier: NCT02944201|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2016
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Carvedilol||Phase 2|
Preclinical research has demonstrated that autonomic nerve fibers in the prostate gland regulate prostate cancer development and dissemination. Studies in human prostate cancer specimens indicate that higher densities of autonomic nerve fibers are associated with poor clinical outcomes.
In this clinical trial the beta-blocker carvedilol will be given to men diagnosed with prostate cancer. Men will begin carvedilol following their diagnostic prostate biopsy and will continue carvedilol until prostatectomy. The primary outcome measure is the change in Ki-67 and TUNEL assay biomarkers in prostate biopsy and prostatectomy tissues.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate|
|Actual Study Start Date :||April 1, 2017|
|Actual Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Carvedilol will be started at 6.25 mg by mouth twice daily. Patients will take carvedilol for 28 days prior to prostatectomy. They will be seen every 7 days and adjustments in the dose will be considered at those visits.
Carvedilol will give twice daily until prostatectomy
Other Name: Coreg
- Change in Biomarkers in Prostate Biopsy Compared to Prostatectomy Tissues [ Time Frame: 28 days after beginning carvedilol ]BIomarker
- Change in Serum PSA [ Time Frame: 28 days after beginning carvedilol ]PSA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944201
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10461|