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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
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

PORT-MAP Trial 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.

PORT-MAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My kidney function, measured by creatinine levels, is within the normal range.
My liver enzymes are within the required limits.
I, or my legal representative, can understand the study and agree to sign the consent form.
I am a man aged 18 or older.
My prostate cancer is diagnosed as adenocarcinoma.
I am scheduled for a complete prostate removal surgery soon.
My kidney function, measured by creatinine levels, is within the normal range.
My liver enzymes are within the required limits.

PORT-MAP Trial Timeline

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
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

PORT-MAP 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.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
467 Previous Clinical Trials
169,307 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings left for prospective participants in this experiment?

"This medical study, which was uploaded to clinicaltrials.gov on the 1st of November 2022 and last updated 4 days later, is not presently recruiting participants. Nonetheless, there are 810 other trials actively welcoming applicants at this time."

Answered by AI
~0 spots leftby May 2025