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Testosterone Therapy in Castration Resistant Prostate Cancer

NCT03734653 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-06

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cancer League of Colorado

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Laura Graham, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-18
Primary Completion
2024-08-14
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03734653 on ClinicalTrials.gov