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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 belowSelect...
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...
I have been diagnosed with prostate cancer.
Select...
I started hormone therapy for cancer within the last 30 days.
Select...
I am on hormone therapy for the entire study or have had both testicles removed.
Select...
I experience moderate-to-severe hot flashes.
Select...
I experience 7 or more hot flashes daily.
Select...
I experience severe hot flashes frequently.
Select...
My organs are functioning well.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
POSH-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
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 morePOSH-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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any drugs that strongly affect liver enzymes or those with a narrow safety margin.I am on hormone therapy for the entire study or have had both testicles removed.My kidney function, measured by creatinine levels, is within the normal range.I am not taking any medications that affect liver enzyme CYP3A4.I experience severe hot flashes frequently.I, or my legal representative, can understand the study and agree to sign the consent form.My organs are functioning well.I am a man aged 18 or older.I have been diagnosed with prostate cancer.I started hormone therapy for cancer within the last 30 days.I haven't had cancer in the last 2 years, except for specific low-risk types or those treated with surgery.I am not planning to use other cancer drugs while in this study, but I may receive radiotherapy.I haven't had a severe infection in the last 2 weeks.I haven't taken excluded medications recently.I experience moderate-to-severe hot flashes.I experience 7 or more hot flashes daily.
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.
Research Study Groups:
This trial has the following groups:- Group 1: 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."
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