Trials Sponsors Conditions Drugs Pricing

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

To evaluate the effect of Osanetant on the testosterone levels.
We will test the ability of Osanetant to suppress testosterone production. A single arm pilot study of Osanetant at 200mg twice daily will be performed. Testosterone levels at baseline will be compared to levels at day 2, 3, 7 ,14, and 28 days of therapy. The overall effect of Osanetant on testosterone levels and the proportion of men achieving castrate levels of testosterone (\<50ng/ml) will be assessed. Additionally, the reversibility of this effect will be assessed by evaluating the testosterone levels at 6-8 weeks posttreatment.
28 days

Secondary Outcomes (4)

To evaluate the effect of Osanetant on LH levels.
28 days
To evaluate the effect of Osanetant on FSH levels.
28 days
To evaluate the effect of Osanetant on estradiol levels
28 days
To evaluate the effect of Osanetant on PSA levels.
28 days

Study Arms (1)

Pilot Trial: Osanetant 28 Days

EXPERIMENTAL

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.

Drug: Osanetant

Interventions

OsanetantDrug

To evaluate the effect of Osanetant on the testosterone levels.

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

1 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

October 31, 2022

First Posted

November 7, 2022

Study Start

January 3, 2023

Actual (reported)

Study Stopped

Pilot of Osanetant to Reduce Testosterone 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 (4)

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 (4)

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