NCT05607342

Pilot of Osanetant to Reduce Testosterone in Men With Adenocarcinoma of the Prostate

Pilot of Osanetant to Reduce Testosterone in Men With Adenocarcinoma of the Prostate (PORT-MAP)

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of Osanetant on testosterone levels in men with prostate cancer within 28 days of therapy.

Detailed description

Primary: To evaluate the effect of Osanetant on testosterone levels in men with prostate cancer within 28 days of therapy. Secondary: * To evaluate the effect Osanetant on pituitary hormones (LH/FSH) and estrogen within 28 days of therapy. * To evaluate the effect of Osanetant on PSA levels after 28 days (approximately 4 weeks) of therapy.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Osanetant	To evaluate the effect of Osanetant on the testosterone levels.

Timeline

• Start date: 2023-01-03
• Primary completion: 2023-09-22
• Completion: 2023-11-06
• First posted: 2022-11-07
• Last updated: 2024-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study