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

NCT03297398 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: SAR-202
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 15

Brief Summary

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).

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in PSA (%) to Week 16

  The trial will evaluate the effect of two doses of OPK-88004 (15 mg and 25 mg) daily for 16 weeks on serum PSA compared with placebo

  16 weeks

Secondary Outcomes (1)

• Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks

  16 weeks

Other Outcomes (5)

• To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Peak Flow Rate (Qmax)

  16 weeks

• To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Mean Flow Rate (Qave)

  16 weeks

• To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter-voided Volume (Vcomp)

  16 weeks

Study Arms (3)

Other

PLACEBO COMPARATOR

Placebo Group

Other: Placebo

Drug Group 1

EXPERIMENTAL

15mg, OPK-88004

Drug: Group-1 (15mg, OPK-88004)

Drug Group 2

EXPERIMENTAL

25,mg OPK-88004

Drug: Group-2 (25 mg,OPK-88004)

Interventions

Group-1 (15mg, OPK-88004) DRUG

15mg, OPK-88004

Also known as: Selective Androgen Receptor Modulator

Drug Group 1

Group-2 (25 mg,OPK-88004) DRUG

25 mg,OPK-88004

Also known as: Selective Androgen Receptor Modulator

Drug Group 2

Placebo OTHER

Placebo

Also known as: Inactive

Other

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (15)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Bayview Research Group, LLC - Valley Village

Valley Village, California, 91607, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

APF Research, LLC

Miami, Florida, 33134, United States

Location

Meridien Research - Brooksville

Spring Hill, Florida, 34609, United States

Location

Florida Urology Partners

Tampa, Florida, 33615, United States

Location

Advanced Clinical Research - Boise

Meridian, Idaho, 83642, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Manhattan Medical Research Practice PLLC

New York, New York, 10016, United States

Location

Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: OPKO Health Inc
• Organization: OPKO Health Inc

contact@opko.com

3055754100

Study Officials

• Militza Vera De Alba, MD

  Dr.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: February 21, 2018
• Primary Completion: April 18, 2019
• Study Completion: June 10, 2019
• Last Updated: September 16, 2021
• Results First Posted: July 28, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)