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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
Timeline
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 belowSelect...
My kidney function, measured by creatinine levels, is within the normal range.
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My liver enzymes are within the required limits.
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I, or my legal representative, can understand the study and agree to sign the consent form.
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I am a man aged 18 or older.
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My prostate cancer is diagnosed as adenocarcinoma.
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I am scheduled for a complete prostate removal surgery soon.
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My kidney function, measured by creatinine levels, is within the normal range.
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My liver enzymes are within the required limits.
PORT-MAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
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 morePORT-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.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,156 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver enzymes are within the required limits.I agree to follow the study's rules about preventing pregnancy during and after treatment.My kidney function is impaired with a creatinine level over 1.8.I haven't taken excluded medications recently.I have a family member with hepatitis or live with someone who has hepatitis.I have or had heart disease, high blood pressure, diabetes, irregular heartbeat, or ECG issues.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.My organs are functioning well.I am not taking any medications that affect liver enzyme CYP3A4.I haven't had a severe infection in the last 2 weeks.I agree to follow the study's rules about preventing pregnancy during and after treatment.I am not taking any drugs that strongly affect liver enzymes or those with a narrow safety range.I am currently using steroids, opioids, spironolactone, or eplerenone.I am allergic to an ingredient in the study medication.I have a history of liver problems, including hepatitis.My liver tests are higher than normal.I am a man aged 18 or older.I, or my legal representative, can understand the study and agree to sign the consent form.My organs are functioning well.I have used hormone therapy for cancer in the last 6 months.I have benign neutropenia but my doctor thinks I can safely join the trial.I am currently taking medication that affects liver enzyme levels.I have been diagnosed with osteoporosis.I currently have COVID-19.My kidney function, measured by creatinine levels, is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Pilot Trial: Osanetant 28 Days
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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