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Neurokinin Antagonist

Osanetant for Hot Flashes in Prostate Cancer (POSH-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
Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
Males ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

POSH-MAP Trial Summary

This trial will test if a drug can reduce the frequency and severity of hot flashes for men on hormone therapy.

Who is the study for?
This trial is for men over 18 with prostate cancer who are experiencing severe hot flashes due to androgen deprivation therapy. They must have been on this therapy for at least 30 days, have a certain severity of hot flashes, and their major organs need to function well. Men whose partners could become pregnant must use contraception during the study.Check my eligibility
What is being tested?
The trial is testing Osanetant's ability to reduce the frequency and severity of hot flashes in men undergoing hormone therapy for prostate cancer. Participants will be given Osanetant while continuing their standard treatment with ADT.See study design
What are the potential side effects?
While specific side effects of Osanetant aren't listed here, common ones may include reactions at the injection site, nausea, fatigue, or changes in liver enzymes. Side effects can vary based on individual health conditions.

POSH-MAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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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I have been diagnosed with prostate cancer.
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I started hormone therapy for cancer within the last 30 days.
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I am on hormone therapy for the entire study or have had both testicles removed.
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I experience moderate-to-severe hot flashes.
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I experience 7 or more hot flashes daily.
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I experience severe hot flashes frequently.
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My organs are functioning well.
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My kidney function, measured by creatinine levels, is within the normal range.

POSH-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
To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT).
Secondary outcome measures
EuroQOL 5-dimension
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
General Anxiety Disorder-7 question (GAD-7)
+6 more

POSH-MAP Trial Design

1Treatment groups
Experimental Treatment
Group I: Pilot Trial: Osanetant 28 DaysExperimental Treatment1 Intervention
Osanetant 200 mg orally, twice per day for 28 days.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
458 Previous Clinical Trials
169,088 Total Patients Enrolled

Media Library

Osanetant (Neurokinin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05647447 — Phase < 1
Prostate Adenocarcinoma Clinical Trial 2023: Osanetant Highlights & Side Effects. Trial Name: NCT05647447 — Phase < 1
Osanetant (Neurokinin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05647447 — Phase < 1
Prostate Adenocarcinoma Research Study Groups: Pilot Trial: Osanetant 28 Days

Frequently Asked Questions

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

Are there any remaining vacancies in this clinical trial?

"According to information publicly accessible on clinicaltrials.gov, this medical research is no longer recruiting patients. It was originally posted in January 1st 2023 and last updated December 7th 2022. Although the trial has closed its doors for participants, there are 841 other trials open right now that may be of interest."

Answered by AI
~0 spots leftby Mar 2025