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Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate

NCT02944201•Montefiore Medical Center

View on ClinicalTrials.gov

Summary

This will be a single arm, window of opportunity study in men with treatment-naïve prostate cancer who will proceed to prostatectomy. Men will be treated with carvedilol prior to undergoing prostatectomy.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. The patient must be able to provide study-specific informed consent prior to study entry.
•2. Age ≥ 18
•3. ECOG Performance Status 0-1
•4. Pathologically proven diagnosis of prostate adenocarcinoma diagnosed by prostate biopsy with archival biopsy tissue available for analysis. The amount of cancer tissue present must be sufficient for analysis.
•5. Prostate adenocarcinoma classified as intermediate or high-risk as defined by one or more of the following criteria: PSA \>10 ng/ml, Gleason score ≥7, or tumor stage ≥T2b
•6. Patients must have no evidence of metastatic disease (including clinically negative pelvic lymph nodes) as established by imaging (CT or MRI of the pelvis and a bone scan) within 60 days prior to registration. Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
•7. The patient and the attending urologist have decided to proceed with prostatectomy
•8. Lab values meeting the following criteria
•1. Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
•2. Aspartate aminotransferase (AST) ≤ 2.5 X ULN.
+5 more criteria

Exclusion Criteria

•9. Patients with low risk prostate adenocarcinoma as defined by meeting all three of the following criteria: Gleason score ≤6, PSA \<10 and tumor stage ≤T2b
•10. The presence of metastatic disease including to pelvic lymph nodes
•12. Prior therapy for prostate cancer including radiation therapy (external beam or brachytherapy), surgery, high-intensity focused ultrasound (HIFU), cryotherapy, previous hormonal therapy with androgen deprivation therapy by bilateral orchiectomy or LHRH analogues (e.g. leuprolide, goserelin, triptorelin, degarelix), antiandrogens, ketoconazole, abiraterone or chemotherapy (for prostate cancer, chemotherapy in the past for other indications is allowed).
•13. Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
•14. No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 5 years.
•15. Inability to take oral medication
•16. Hypotension (systolic blood pressure \<100 mm Hg or diastolic blood pressure \<50 mm Hg) or bradycardia (pulse \<55 beats/min) at screening. For patients with a functioning pacemaker, bradycardia is not an exclusion.
•17. Bronchial asthma or related bronchospastic conditions such as chronic obstructive pulmonary disease.
•18. Patients must not have New York Heart Association Class III or IV heart failure at the time of screening. Patients must not have any unstable angina, myocardial infarction, or serious uncontrolled cardiac arrhythmia within 6 months prior to registration.
•19. Prolonged QTc interval on pre-entry 12-lead ECG (\> 460 msec), obtained within 28 days prior to being registered on study. No second- or third-degree atrioventricular block on screening 12-lead ECG.
+1 more criteria

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Key Dates

Start Date

April 1, 2017

Primary Completion Date

December 31, 2020

Completion Date

December 31, 2021

Last Updated

February 21, 2021

Enrollment

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

Carvedilol

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate

Inclusion Criteria

Exclusion Criteria

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