This trial is active, not recruiting.

Condition prostatic neoplasms
Treatments vt-122, placebo
Phase phase 2
Sponsor Vicus Therapeutics
Start date June 2013
End date April 2016
Trial size 90 participants
Trial identifier NCT01857817, VT1-SYS-601


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
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.
vt-122 propranolol
The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.
(Placebo Comparator)
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.
The placebo capsules will be prepared to match the active drug.

Primary Outcomes

Change in prostate specific antigen (PSA)
time frame: baseline (Day 1 Cycle 1) to 12 weeks (Day 1, Cycle 4)

Secondary Outcomes

PSA progression
time frame: baseline to 12 weeks
PSA doubling time (PSADT)
time frame: baseline and every month during treatment
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
Time to symptom progression (TTSP)
time frame: Day 1 Cycle 1 and Day 1 of each subsequent 28-day cycle
Change in correlative biomarkers
time frame: Day 1 Cycle 1, on Day 1 of each subsequent 28-day cycle, and on end of treatment

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title A Randomized, Placebo Controlled, Multicenter Phase 2 Study of Etodolac and Propranolol in Patients With Clinically Progressive Prostate Cancer
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Vicus Therapeutics.
Location data was received from the National Cancer Institute and was last updated in March 2016.