NCT03734653

Testosterone Therapy in Castration Resistant Prostate Cancer

Square Wave Testosterone Therapy in Castration Resistant Prostate Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is an open-labeled, single-arm, interventional pilot study. It is being done to determine the feasibility of the administration of transdermal testosterone alternating with enzalutamide, as well as the safety and efficacy.

Detailed description

The primary endpoint of this trial is to determine the feasibility of the administration of transdermal testosterone alternating with enzalutamide. High dose testosterone has shown activity in phase II studies of patients with castration resistant metastatic prostate cancer; however, these studies have generally employed the intramuscular formulation. It has been hypothesized that the transdermal formulation will show activity but will have less potential for toxicity due to extremely high levels of circulating testosterone (i.e. thrombotic events). In addition, this will allow for a steady state of elevated testosterone, rather than the peaks and troughs seen with the IM approach.

Conditions

• Prostate Cancer
• Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Transdermal Testosterone	Patients will be prescribed 2 packets of testosterone gel 1% containing 50mg per packet to apply transdermally daily.
DRUG	Standard of Care, Enzalutamide	Patients will take four 40mg capsules of enzalutamide for a total daily dose of 160mg.

Timeline

• Start date: 2019-01-18
• Primary completion: 2024-08-14
• Completion: 2025-09-30
• First posted: 2018-11-08
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study