Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02944201
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Albert Einstein College of Medicine
Information provided by (Responsible Party):
Benjamin Gartrell, Montefiore Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Carvedilol Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carvedilol
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.
Drug: Carvedilol
Carvedilol will give twice daily until prostatectomy
Other Name: Coreg




Primary Outcome Measures :
  1. Change in Biomarkers in Prostate Biopsy Compared to Prostatectomy Tissues [ Time Frame: 28 days after beginning carvedilol ]
    BIomarker


Secondary Outcome Measures :
  1. Change in Serum PSA [ Time Frame: 28 days after beginning carvedilol ]
    PSA



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
    3. Alanine aminotransferase (ALT ) ≤ 2.5 X ULN
    4. Absolute Neutrophil Count (ANC) > 1.5 K/mm3
    5. Platelets > 100 K/mm3
    6. Hemoglobin ≥9.0 g/dL
    7. calculated creatinine clearance ≥ 40 mL/min

    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
  11. Use of any beta-blocker at the time of diagnostic biopsy for prostate cancer or use of any beta-blocker at the time of screening. If the investigator does not believe that carvedilol can be safely added to the patients existing antihypertensive regimen, then the patient is not eligible for this study.
  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.
  20. Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Benjamin Gartrell, MD 718-405-8404 bgartrel@montefiore.org

Locations
Layout table for location information
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Benjamin Gartrell, MD    718-405-8404    bgartrel@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Albert Einstein College of Medicine

Publications:
Layout table for additonal information
Responsible Party: Benjamin Gartrell, Assistant Professor of Oncology, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02944201     History of Changes
Other Study ID Numbers: 2016-6632
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Gartrell, Montefiore Medical Center:
carvedilol
biomarkers
autonomic nerves
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carvedilol
Adrenergic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists