← Back to Search

Neurokinin Antagonist

Osanetant for Prostate Cancer (PORT-MAP Trial)

Phase < 1

Waitlist Available

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation

Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN

Must not have

Current or recent (within 6 months) use of testosterone/estrogen modulating agents (leuprolide, degarelix, bicalutamide, enzalutamide, apalutamide, darolutamide, abiraterone, systemic ketoconazole, tamoxifen, etc)

Current use of CYP3A4 inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Summary

This trial will test if a drug can raise testosterone in men with prostate cancer.

Who is the study for?

Men over 18 with prostate adenocarcinoma, scheduled for radical prostatectomy, and not on certain drugs affecting liver enzymes. They must have normal organ function, a testosterone level above 150ng/ml, and agree to contraception during the study.Check my eligibility

What is being tested?

The trial is testing Osanetant's ability to lower testosterone levels in men with prostate cancer within 28 days before their surgery.See study design

What are the potential side effects?

Specific side effects of Osanetant are not listed here but may include typical drug reactions such as nausea, headaches, dizziness or allergic responses. Monitoring will occur for any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney function, measured by creatinine levels, is within the normal range.

Select...

My liver enzymes are within the required limits.

Select...

I, or my legal representative, can understand the study and agree to sign the consent form.

Select...

I am a man aged 18 or older.

Select...

My prostate cancer is diagnosed as adenocarcinoma.

Select...

I am scheduled for a complete prostate removal surgery soon.

Select...

My kidney function, measured by creatinine levels, is within the normal range.

Select...

My liver enzymes are within the required limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have used hormone therapy for cancer in the last 6 months.

Select...

I am currently taking medication that affects liver enzyme levels.

Select...

I am not taking any drugs that strongly affect liver enzymes or those with a narrow safety range.

Select...

My kidney function is impaired with a creatinine level over 1.8.

Select...

I have been diagnosed with osteoporosis.

Select...

I am currently using steroids, opioids, spironolactone, or eplerenone.

Select...

I am allergic to an ingredient in the study medication.

Select...

I haven't had a severe infection in the last 2 weeks.

Select...

I currently have COVID-19.

Select...

I have a history of liver problems, including hepatitis.

Select...

My liver tests are higher than normal.

Select...

I have or had heart disease, high blood pressure, diabetes, irregular heartbeat, or ECG issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Testosterone

Secondary outcome measures

To evaluate the effect of Osanetant on FSH levels.

Luteinizing hormone

To evaluate the effect of Osanetant on PSA levels.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pilot Trial: Osanetant 28 DaysExperimental Treatment1 Intervention

Pilot Trial: A single dose level (200mg twice daily, oral) will be provided for men with prostate cancer undergoing curative intent surgery. Men will undergo serum testing at baseline, days 2, 3, 7, 14, and 28 as well as 6 weeks post-treatment in order to evaluate efficacy. All men enrolled will be subject to the same study procedures and assessments, regardless of completion of the study protocol, and analysis will occur via intent-to-treat principles.

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

472 Previous Clinical Trials

171,438 Total Patients Enrolled

Media Library

Osanetant (Neurokinin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05607342 — Phase < 1

Prostate Adenocarcinoma Research Study Groups: Pilot Trial: Osanetant 28 Days

Prostate Adenocarcinoma Clinical Trial 2023: Osanetant Highlights & Side Effects. Trial Name: NCT05607342 — Phase < 1

Osanetant (Neurokinin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607342 — Phase < 1

~0 spots leftby Jul 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.