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Efficacy and Safety Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01857817
Recruitment Status : Terminated (Low patient recruitment)
First Posted : May 20, 2013
Last Update Posted : April 26, 2018
Information provided by (Responsible Party):
Vicus Therapeutics

Brief Summary:
The purpose of this study is to evaluate the clinical benefit of the co-administration of propranolol and etodolac (VT-122 therapy) in patients with clinically progressive prostate cancer.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: VT-122 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Multicenter Phase 2 Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
Study Start Date : June 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: VT-122 with physician's choice therapy
Participants will receive oral doses of 66 mg propranolol and 680 mg etodolac daily. Propranolol will be administered 44 mg with breakfast and 22 mg in the mid-afternoon (3PM). Etodolac will be administered 340 mg with breakfast and 340 mg with dinner.
Drug: VT-122
The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.
Other Names:
  • propranolol
  • etodolac

Placebo Comparator: Placebo with physician's choice therapy
Participants will receive physician's choice therapy as the standard of care as well as the placebo capsules that are of the same weight as propranolol and etodolac.
Drug: Placebo
The placebo capsules will be prepared to match the active drug.

Primary Outcome Measures :
  1. Change in prostate specific antigen (PSA) [ Time Frame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4) ]

Secondary Outcome Measures :
  1. PSA progression [ Time Frame: baseline to 12 weeks ]
  2. PSA doubling time (PSADT) [ Time Frame: baseline and every month during treatment ]
  3. Change in self-reported performance (EQ-5D), pain (visual analog scale [VAS] and opiate usage) [ Time Frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment ]
  4. Time to symptom progression (TTSP) [ Time Frame: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle ]
  5. Change in correlative biomarkers [ Time Frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Have a confirmed diagnosis of prostate cancer
  2. Male participants who are ≥18 years of age
  3. In the opinion of the investigator, the participants have a life expectancy of at least 3 months.
  4. Two consecutively rising PSA values or two out of three rising PSA values (2.0 ng/mL is the minimum ending value for PSA) at a minimum of 1-week intervals
  5. Have a Karnofsky Performance Score (KPS) equal to or greater than 70
  6. Have the following laboratory parameters (may be assessed locally):

    1. Platelet count ≥50 x 10E3/µL
    2. Total bilirubin ≤1.5 mg/dL
    3. Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance >60 mL/min calculated using Cockcroft-Gault
    4. Liver enzymes [aspartate transaminase (AST), alanine transaminase (ALT)] ≤2 x ULN
  7. Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice

Exclusion Criteria:

  1. The patient has a history of another primary cancer, with the exception of:

    1. Curatively resected non-melanomatous skin cancer;
    2. Other primary solid tumor with no known active disease presents that in the opinion of the investigator that will not affect patient outcome in the setting of current prostate cancer diagnosis.
  2. Contraindication to propranolol, etodolac
  3. Patients on beta blockers
  4. Patients receiving chemotherapy (e.g., docetaxel, cabazitaxel, taxane, or platinum as single agents or in combination) as their cancer treatment
  5. History or evidence of cardiac disease: congestive heart failure; New York Heart Association class 2 or greater; active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization
  6. Hypotension at the time of screening (i.e., systolic blood pressure less than 110 mmHg. Diastolic blood pressure less than 60 mmHg)
  7. Resting heart rate less than 60 bpm at time of screening
  8. Any uncontrolled, intercurrent illness that in the opinion of the Investigator may interfere with study evaluation. Participants with uncontrolled diabetes will be excluded from the study.
  9. On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine, dopamine, dobutamine, epinephrine, isoproterenol)
  10. Active clinically serious infections [> Grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0]
  11. Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results
  12. Known or suspected allergy to the investigational agents or any agent given in association with this trial (hypersensitivity reaction, hives, rash, difficulty breathing swelling of your face, lips, tongue, or throat)
  13. Any condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the study
  14. Patients with uncontrolled diabetes or insulin resistance
  15. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening 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): NCT01857817

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United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, California
Redwood Regional Medical Group
Santa Rosa, California, United States, 95403
United States, Colorado
Advanced Urology
Parker, Colorado, United States, 80134
United States, Florida
Manatee Medical Research Institute, LLC
Bradenton, Florida, United States, 34205
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
United States, Illinois
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Detroit Clinical Research Center, PC
Lansing, Michigan, United States, 48912
United States, Minnesota
Adult & Pediatric Urology
Sartell, Minnesota, United States, 56377
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
AccuMed Research Associates
Garden City, New York, United States, 11530
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States, 12601
United States, Texas
Hendrick Cancer Center
Abilene, Texas, United States, 79601
Oncology Consultants, P.A.
Houston, Texas, United States, 77030
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Medical Oncology Associates, PS
Spokane, Washington, United States, 99208
Sponsors and Collaborators
Vicus Therapeutics
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Responsible Party: Vicus Therapeutics
ClinicalTrials.gov Identifier: NCT01857817    
Other Study ID Numbers: VT1-SYS-601
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors