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

NCT02944201 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 2016-6632
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

carvedilol; biomarkers; autonomic nerves

Outcome Measures

Primary Outcomes (1)

• Change in Biomarkers in Prostate Biopsy Compared to Prostatectomy Tissues

  BIomarker

  28 days after beginning carvedilol

Secondary Outcomes (1)

• Change in Serum PSA

  28 days after beginning carvedilol

Study Arms (1)

Carvedilol

EXPERIMENTAL

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

Interventions

Carvedilol DRUG

Carvedilol will give twice daily until prostatectomy

Also known as: Coreg

Carvedilol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be able to provide study-specific informed consent prior to study entry.
• Age ≥ 18
• ECOG Performance Status 0-1
• 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.
• 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
• 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.
• The patient and the attending urologist have decided to proceed with prostatectomy
• Lab values meeting the following criteria
• Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
• Aspartate aminotransferase (AST) ≤ 2.5 X ULN.
• Alanine aminotransferase (ALT ) ≤ 2.5 X ULN
• Absolute Neutrophil Count (ANC) \> 1.5 K/mm3
• Platelets \> 100 K/mm3
• Hemoglobin ≥9.0 g/dL
• calculated creatinine clearance ≥ 40 mL/min

You may not qualify if:

• 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
• The presence of metastatic disease including to pelvic lymph nodes
• 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.
• 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).
• Treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
• 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.
• Inability to take oral medication
• Bronchial asthma or related bronchospastic conditions such as chronic obstructive pulmonary disease.
• 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.
• 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.
• Any other serious illness or medical condition that the principal investigator feels would make the patient a poor candidate for this study

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Albert Einstein College of Medicine: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• Magnon C, Hall SJ, Lin J, Xue X, Gerber L, Freedland SJ, Frenette PS. Autonomic nerve development contributes to prostate cancer progression. Science. 2013 Jul 12;341(6142):1236361. doi: 10.1126/science.1236361.

  PMID: 23846904 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Oncology

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 25, 2016
• Study Start: April 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)