Trials Sponsors Conditions Drugs Pricing

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

To evaluate the preliminary efficacy of in reducing the frequency and severity of vasomotor symptoms (VMS) in men on androgen deprivation therapy (ADT).
Efficacy will be assessed using a composite outcome of median weekly hot flash frequency and severity at week 4 compared to baseline.
28 days

Secondary Outcomes (9)

To evaluate the effect of Osanetant on follicle stimulating hormone for men with prostate cancer on ADT.
28 days
To evaluate the effect of Osanetant on luteinizing hormone for men with prostate cancer on ADT.
28 days
To evaluate the effect of Osanetant on testosterone for men with prostate cancer on ADT.
28 days
To evaluate the effect of Osanetant on estradiol for men with prostate cancer on ADT.
28 days
Functional Assessment of Cancer Therapy-Prostate (FACT-P)
28 days
+4 more secondary outcomes

Study Arms (1)

Pilot Trial: Osanetant 28 Days

EXPERIMENTAL

Osanetant 200 mg orally, twice per day for 28 days.

Drug: Osanetant

Interventions

OsanetantDrug

Osanetant 200 mg orally, twice per day

Pilot Trial: Osanetant 28 Days

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

University of Kansas Medical Center
Otherlead

Study Sites (1)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

MeSH Terms

Interventions

SR 142801

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

December 12, 2022

Study Start

January 3, 2023

Actual (reported)

Study Stopped

Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Pilot Trial: Osanetant 28 Days

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Pilot Trial: Osanetant 28 Days

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations