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

August 23, 2021 updated by: OPKO Health, Inc.

A Randomized, Double-blind, Placebo-controlled Dose-ranging Study of OPK-88004 Once-a-day Dosing for 16 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study SAR-202 is a phase 2 multicenter, placebo-controlled, double-blind trial to evaluate the effect of OPK-88004 doses (OPK-88004 15 mg, or OPK-88004 25 mg) on serum PSA compared to placebo in men with BPH. Approximately 115 men with BPH will be enrolled in the study, randomized 1:1:1 across three arms (placebo, OPK-88004 15 mg, or OPK-88004 25 mg). The trial will be conducted at approximately up to 35 sites within the US.

The study duration for individual subjects will be up to 24 weeks and will include three phases:

  • a screening period (up to 4 weeks, including 1-week washout if required),
  • a treatment period (16 weeks), and
  • a follow-up period (4 weeks) Subjects will be randomized and receive their first dose of study drug at visit 2. They will begin the once daily oral dosing regimen and return every 4 weeks to the study site during the 16-week treatment period. Assessments during the study period will include vital signs, laboratory testing, weight, adverse events (AEs), concomitant drugs, and study drug compliance. Efficacy assessments will include serum PSA, LBM and fat mass by DXA scans, uroflowmetry parameters, PVR (by ultrasound), and assessment of symptoms by IPSS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group
    • California
      • Lincoln, California, United States, 95648
        • Clinical Trials Research
      • Sacramento, California, United States, 95821
        • Northern California Research
      • Valley Village, California, United States, 91607
        • Bayview Research Group, LLC - Valley Village
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Miami, Florida, United States, 33134
        • APF Research, LLC
      • Spring Hill, Florida, United States, 34609
        • Meridien Research - Brooksville
      • Tampa, Florida, United States, 33615
        • Florida Urology Partners
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research - Boise
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
      • New York, New York, United States, 10016
        • Manhattan Medical Research Practice PLLC
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

Subjects are eligible if they meet the following criteria:

  1. Present with BPH-LUTS based on disease diagnostic criteria at visit 1
  2. Are men aged 45 years or older at visit 1
  3. Have prostate volume >40 cm3 and <80 cm3 assessed by TRUS at visit 1
  4. 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
  5. 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
  6. 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
  7. Have not received prior treatment with 5-ARIs (finasteride, dutasteride) within the past one year for any indication
  8. 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
  9. 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
  10. 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
  11. 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
  12. Have given written informed consent

Exclusion Criteria

Patients will be excluded from study enrollment if they meet any of the following criteria at visit 1:

  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
  2. Lower urinary tract instrumentation (including prostate biopsy) within 6 weeks prior to screening PSA blood draw
  3. History of urinary retention or lower urinary tract (bladder) stones within 1 month of visit 1
  4. 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
  5. Clinical evidence of urinary tract infection or urinary tract inflammation (including prostatitis)
  6. Intravesical obstruction (eg, intravesical median lobe of the prostate)
  7. Current neurologic disease or condition associated with neurogenic bladder (eg, Parkinson's disease, multiple sclerosis)
  8. History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <45 mL/min
  9. Active hepatobiliary disease or serologic evidence of active hepatitis A, B, C, hepatitis E or HIV
  10. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2X the upper limit of normal (ULN)
  11. Glycosylated hemoglobin (HbA1c) >9%
  12. Hematocrit ≥50%
  13. HDL-C <35 mg/dL and LDL-C >130 mg/dL
  14. QTcB interval >450 msec. For heart rates over 75, the ECG may be repeated after 5 minutes of resting quietly
  15. 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

  16. 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
  17. Any evidence of heart disease (NYHA ≥Class II, Appendix 4) within 6 months, or are receiving treatment for congestive heart failure (CHF)
  18. Any supraventricular or ventricular arrhythmia with uncontrolled ventricular response (mean heart rate >100 bpm) at rest despite medical therapy
  19. Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg as determined by a sitting measurement (if stress is suspected, retest up to two times under basal conditions), or malignant hypertension
  20. Have a history or presence of prostatic carcinoma, as well as any conditions that may be exacerbated by androgenic medications such as (but not limited to) epilepsy, seizures, convulsions, migraine or polycythemia
  21. History of cancer within the previous 5 years, except for excised superficial lesions (such as basal cell carcinoma and squamous cell carcinoma of the skin)
  22. History of drug, alcohol, or substance abuse within 6 months
  23. Have an alcohol intake of ≥3 units/day or ≥14 units/week during the study (1 unit = 12 ounces of beer, 5 ounces of wine, 1.5 ounces of distilled spirits)
  24. Any condition that would interfere with subject's ability to provide informed consent or comply with study instructions, would impair ability to perform the study assessments, or would place subject at increased risk, or might confound the interpretation of the study results
  25. Current treatment with androgens, antiandrogens, estrogens, or anabolic steroids within the prior 1 month. Any prior or current treatment with LHRH agonists/antagonists
  26. Current treatment with potent CYP3A4 inhibitors such as itraconazole or ritonavir
  27. Have taken prescription or over-the-counter medications to promote weight loss within the prior 3 months
  28. Any prior use of OPK-88004 Allergic to any component of OPK-88004

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Other
Placebo Group
Other: Placebo
Placebo
Other Names:
  • Inactive
Experimental: Drug Group 1
15mg, OPK-88004
Drug: Group-1 (15mg, OPK-88004)
15mg, OPK-88004
Other Names:
  • Selective Androgen Receptor Modulator
Experimental: Drug Group 2
25,mg OPK-88004
Drug: Group-2 (25 mg,OPK-88004)
25 mg,OPK-88004
Other Names:
  • Selective Androgen Receptor Modulator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in PSA (%) to Week 16
Time Frame: 16 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks
Time Frame: 16 weeks
To assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass
16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Peak Flow Rate (Qmax)
Time Frame: 16 weeks
Analysis peak flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
16 weeks
To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Mean Flow Rate (Qave)
Time Frame: 16 weeks
Analysis mean flow rate of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
16 weeks
To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter-voided Volume (Vcomp)
Time Frame: 16 weeks
Analysis voided of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
16 weeks
To Evaluate the Effect of OPK-88004 on Uroflowmetry Parameter- Postvoid Residual Volume (PVR)
Time Frame: 16 weeks
Analysis postvoid residual volume of Uroflowmetry Parameters and Postvoid Residual Volume Observed Change from Baseline to Week 16
16 weeks
International Prostate Symptom Score- IPSS
Time Frame: 16 weeks
To evaluate the effects of OPK-88004 on the symptoms of BPH as determined by International prostate symptom score (IPSS score), Total IPSS score as measured by the sum of questions 1 through 7, the IPSS Irritative Domain (sum of questions 2, 4 and 7), and the IPSS Obstructive Domain (sum of questions 1, 3, 5 and 6)IPSS QoL question (IPSS question 8). Mild (symptoms score less than or equal to 7), moderate (symptoms score range 8-19), severe (symptom score 20-35)
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OPKO Health, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Militza Vera De Alba, MD, Dr.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAR-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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