Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antihypertensive Agents

Channel Blockers

Vasodilator Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Carvedilol

Adrenergic Agents

Adrenergic beta-Antagonists

Adrenergic Antagonists

Neurotransmitter Agents

Antioxidants

Protective Agents

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Adrenergic alpha-1 Receptor Antagonists

Adrenergic alpha-Antagonists

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

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.

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.

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

Albert Einstein College of Medicine

Montefiore Medical Center

Assistant Professor of Oncology

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Procedure/Surgery: Mesorectal excision with lateral lymph node dissection

Procedure/Surgery: Mesorectal excision without lateral lymph node excision

Mesorectal excision with lateral lymph node dissection

Mesorectal excision without lateral lymph node excision

Shin Fujita, MD

The purpose of this study is to evaluate the of international standard operation, mesorectal excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer

Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME or ME without lateral lymph node dissection is the standard. In order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.

Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)

Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)

Ministry of Health, Labour and Welfare, Japan

Haruhiko Fukuda

JCOG Data Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate	NCT02944201	Prostate Cancer	Carvedilol	18 Years -	Montefiore Medical Center
Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate	NCT02944201	Prostate Cancer	Carvedilol	18 Years -	Montefiore Medical Center
Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate	NCT02944201	Prostate Cancer	Carvedilol	18 Years -	Montefiore Medical Center
Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)	NCT00190541	Rectal Neoplasm...	Mesorectal exci... Mesorectal exci...	21 Years - 74 Years	Japan Clinical Oncology Group

Spots Global Cancer Trial Database for autonomic nerves