Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Benign Prostatic Hyperplasia

In brief

This study will evaluate the safety and effectiveness of different doses of OPK-88004 compared to placebo on serum PSA compared to placebo in men with benign prostatic hyperplasia (BPH).

Key facts

Study ID

NCT03297398

Run by

OPKO Health, Inc.

People needed

114

Starts

2018-02-21

Expected to finish

2019-06-10

Last updated by the study team

2021-09-16

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subjects are eligible if they meet the following criteria:
• Present with BPH-LUTS based on disease diagnostic criteria at visit 1
• Are men aged 45 years or older at visit 1
• Have prostate volume >40 cm3 and <80 cm3 assessed by TRUS at visit 1
• Have a PSA >1.5 and <10.0 ng/mL at visit 1. This PSA blood draw must be performed at least 1 week after any digital rectal exam (DRE) and/or transrectal ultrasound (TRUS) procedures
• Subjects with a PSA ≥4.0 and <10.0 ng/mL must have documentation of a negative histologic biopsy of carcinoma of the prostate within 12 months of screening (visit 1). For subjects aged ≤80 years and who have not undergone any invasive urological procedure within 6 months, if biopsy has not been performed, then 4Kscore Test value must be <7.5% at visit 1
• Have laboratory tests within normal limits (with the exception of total serum or free testosterone). If laboratory test results are outside normal limits they are determined to be not clinically significant at visit 1
• Have not received prior treatment with 5-ARIs (finasteride, dutasteride) within the past one year for any indication
• Have not received herbal BPH preparations within 1 week of visit 1. If the subject is currently on such treatment, a 1-week washout period will be required
• Agree not to use 5-ARIs, herbal or experimental treatments for BPH, at any time during the study. Subjects on daily PDE5i's, alpha-blockers or anticholinergic medications for BPH should remain on a stable dose during the study, unless a change in dose is medically warranted. Occasional-use PDE5i's for ED are permitted at a stable dose and frequency, however should not be taken within 72 hours prior to a study visit
• Agree to use an acceptable method of birth control during the study and for 60 days after the last dose of IP, unless the female partner is postmenopausal. Postmenopausal is defined as a female >50 years of age and 12 months of amenorrhea, or surgically postmenopausal
• Are reliable and willing to make themselves available for the duration of the study, and who will comply with the required study and dosing visits and abide by the Clinical Research Site policy and procedure and study restrictions
• Have given written informed consent

You may not qualify if…

• Patients will be excluded from study enrollment if they meet any of the following criteria at visit 1:
• History of any of the following pelvic conditions:
• radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection
• pelvic radiotherapy
• any pelvic surgical procedure on the urinary tract, including transurethral resection of the prostate (TURP), penile implant surgery
• lower urinary tract malignancy or trauma
• pelvic surgery or any other pelvic procedure less than 6 months prior to visit 1
• Lower urinary tract instrumentation (including prostate biopsy) within 6 weeks prior to screening PSA blood draw
• History of urinary retention or lower urinary tract (bladder) stones within 1 month of visit 1
• Minimally invasive procedures for BPH, such as prostatic stent, high intensity focused ultrasound (HIFU), holmium laser enucleation of prostate (HoLEP), interstitial laser coagulation (ILC), transurethral electroevaporation of the prostate (TUVP), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), photoselective vaporization (PVP), UroLift, within 6 weeks
• Clinical evidence of urinary tract infection or urinary tract inflammation (including prostatitis)
• Intravesical obstruction (eg, intravesical median lobe of the prostate)
• Current neurologic disease or condition associated with neurogenic bladder (eg, Parkinson's disease, multiple sclerosis)
• History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <45 mL/min
• Active hepatobiliary disease or serologic evidence of active hepatitis A, B, C, hepatitis E or HIV
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2X the upper limit of normal (ULN)
• Glycosylated hemoglobin (HbA1c) >9%
• Hematocrit ≥50%
• HDL-C <35 mg/dL and LDL-C >130 mg/dL
• QTcB interval >450 msec. For heart rates over 75, the ECG may be repeated after 5 minutes of resting quietly
• Abnormality in ECG (eg, left bundle branch block, complete right bundle branch block, or delayed intraventricular conduction with a QRS interval >120 msec) that in the opinion of the investigator places the subject at an unacceptable risk for study participation, or subject has implanted pacemaker
• History of any of the following cardiac/coronary conditions within 90 days:
• history of myocardial infarction or coronary artery bypass graft
• percutaneous coronary intervention
• stroke

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Clinical Trials Research — Lincoln, California, United States
• Northern California Research — Sacramento, California, United States
• Bayview Research Group, LLC - Valley Village — Valley Village, California, United States
• South Florida Medical Research — Aventura, Florida, United States
• APF Research, LLC — Miami, Florida, United States
• Meridien Research - Brooksville — Spring Hill, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• Advanced Clinical Research - Boise — Meridian, Idaho, United States
• Regional Urology — Shreveport, Louisiana, United States
• Centennial Medical Group — Elkridge, Maryland, United States
• AccuMed Research Associates — Garden City, New York, United States
• Manhattan Medical Research Practice PLLC — New York, New York, United States
• Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville — Knoxville, Tennessee, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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