Benign Prostatic HyperplasiaPhase 2NCT03297398
Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
A Phase 2 study testing Group-1 (15mg, OPK-88004) and Group-2 (25 mg,OPK-88004) in people with Benign Prostatic Hyperplasia, run by OPKO Health, Inc. at 15 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Group-1 (15mg, OPK-88004) and Group-2 (25 mg,OPK-88004)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Feb 2018to 10 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 37Show fewer
- 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
- Any evidence of heart disease (NYHA ≥Class II, Appendix 4) within 6 months, or are receiving treatment for congestive heart failure (CHF)
- Any supraventricular or ventricular arrhythmia with uncontrolled ventricular response (mean heart rate >100 bpm) at rest despite medical therapy
- 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
- 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
- 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)
- History of drug, alcohol, or substance abuse within 6 months
- 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)
- 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
- Current treatment with androgens, antiandrogens, estrogens, or anabolic steroids within the prior 1 month. Any prior or current treatment with LHRH agonists/antagonists
- Current treatment with potent CYP3A4 inhibitors such as itraconazole or ritonavir
- Have taken prescription or over-the-counter medications to promote weight loss within the prior 3 months
- Any prior use of OPK-88004 Allergic to any component of OPK-88004
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Pinnacle Research Group
Anniston, Alabama, 36207
South Florida Medical Research
Aventura, Florida, 33180
Centennial Medical Group
Elkridge, Maryland, 21075
AccuMed Research Associates
Garden City, New York, 11530
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, 37920
Clinical Trials Research
Lincoln, California, 95648
Advanced Clinical Research - Boise
Meridian, Idaho, 83642
APF Research, LLC
Miami, Florida, 33134
Manhattan Medical Research Practice PLLC
New York, New York, 10016
Northern California Research
Sacramento, California, 95821
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Regional Urology
Shreveport, Louisiana, 71106
Meridien Research - Brooksville
Spring Hill, Florida, 34609
Florida Urology Partners
Tampa, Florida, 33615
Bayview Research Group, LLC - Valley Village
Valley Village, California, 91607
About this study
Official title: 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).
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Group-1 (15mg, OPK-88004), Group-2 (25 mg,OPK-88004), Placebo
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-1 (15mg, OPK-88004)Drug
Also called Selective Androgen Receptor Modulator
15mg, OPK-88004
Group-2 (25 mg,OPK-88004)Drug
Also called Selective Androgen Receptor Modulator
25 mg,OPK-88004
PlaceboOther
Also called Inactive
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Other | Placebo comparator | Placebo Group Receives: Other: Placebo |
| Drug Group 1 | Experimental | 15mg, OPK-88004 Receives: Drug: Group-1 (15mg, OPK-88004) |
| Drug Group 2 | Experimental | 25,mg OPK-88004 Receives: Drug: Group-2 (25 mg,OPK-88004) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (1)
Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks
To assess the effect of OPK-88004 on body composition by DXA, specifically Lean Body Mass (LBM) and fat mass
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start21 Feb 2018
- Primary completion18 Apr 2019
- Study completion10 Jun 2019
Why it stopped: study terminated by sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Militza Vera De Alba, MD, Study director, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297398
- Sponsor's protocol ID
- SAR-202
- Status last verified
- Aug 2021
- First submitted
- 26 Sep 2017
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03297398
- Acronym / sponsor ID
- SAR-202
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated by sponsor decision
- Enrolment
- 114 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Posted 28 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Other | Placebo comparator | Other: PlaceboPlacebo Group |
| Drug Group 1 | Experimental | Drug: Group-1 (15mg, OPK-88004)15mg, OPK-88004 |
| Drug Group 2 | Experimental | Drug: Group-2 (25 mg,OPK-88004)25,mg OPK-88004 |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (37 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-1 (15mg, OPK-88004)Also: Selective Androgen Receptor Modulator15mg, OPK-88004 | Drug | Drug Group 1 |
| Group-2 (25 mg,OPK-88004)Also: Selective Androgen Receptor Modulator25 mg,OPK-88004 | Drug | Drug Group 2 |
| PlaceboAlso: InactivePlacebo | Other | Other |
Primary outcome
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
1 secondary outcome
Absolute Change in Lean Body Mass and Fat Mass From Baseline to 16 Weeks
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Benign Prostatic Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Militza Vera De Alba, MD study director
Dr.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group-1 (15mg, OPK-88004) and Group-2 (25 mg,OPK-88004) in people with Benign Prostatic Hyperplasia, run by OPKO Health, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in PSA (%) to Week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.