Hormone Therapy

Testosterone Undecanoate for Prostate Cancer

Phase 2
Recruiting
Led By Samuel Denmeade, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Study Summary

This trial will analyze the effects of oral testosterone therapy given on a schedule of seven days of therapy followed by seven days of no therapy for a 28 day cycle in men with metastatic castrate resistant prostate cancer.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate of Oral Testosterone Undecanoate (CT Scan)
Secondary outcome measures
Change in Quality of Life as Assessed by the- Short Form 36 (SF-36) Questionnaire
Change in Quality of Life as Assessed by the-FACIT-Fatigue Questionnaire
Objective Response Rate of Enzalutamide Therapy (CT Scan)
+11 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral Testosterone Therapy given until radiographic progression followed by Enzalutamide TherapyExperimental Treatment2 Interventions
Oral Testosterone Therapy-396 mg given twice per day on days 1-7 and 15-21 of a 28 day cycle until radiographic progression. After a 21 day washout period, Enzalutamide therapy given at 160 mg once daily will be taken for a maximum of 6 cycles while on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone undecanoate
FDA approved
Enzalutamide
FDA approved

Find a site

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
546 Previous Clinical Trials
32,620 Total Patients Enrolled
53 Trials studying Prostate Cancer
3,147 Patients Enrolled for Prostate Cancer
Clarus TherapeuticsUNKNOWN
2 Previous Clinical Trials
60 Total Patients Enrolled
Samuel Denmeade, MDPrincipal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
7 Previous Clinical Trials
543 Total Patients Enrolled
4 Trials studying Prostate Cancer
138 Patients Enrolled for Prostate Cancer

Media Library

Testosterone Undecanoate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05081193 — Phase 2
Prostate Cancer Research Study Groups: Oral Testosterone Therapy given until radiographic progression followed by Enzalutamide Therapy
Prostate Cancer Clinical Trial 2023: Testosterone Undecanoate Highlights & Side Effects. Trial Name: NCT05081193 — Phase 2
Testosterone Undecanoate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081193 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this experiment at the moment?

"According to clinicaltrials.gov, this medical trial is presently accepting participants. It was initially posted on March 7th 2022 and the details were most recently modified on May 6th of the same year."

Answered by AI

In what type of medical conditions is Testosterone Undecanoate commonly prescribed?

"Testosterone Undecanoate is a viable therapeutic option for treating hypogonadotropic hypogonadism, castration-associated syndromes, and hypergonadotropic hypogonadism."

Answered by AI

What potential risk factors are associated with Testosterone Undecanoate?

"Testosterone Undecanoate has had prior safety data collected, granting it a score of 2. Thus far, there have been no studies which demonstrate efficacy in this field."

Answered by AI

Are there any previous investigations involving Testosterone Undecanoate?

"Presently, 105 clinical trials researching Testosterone Undecanoate are being conducted, 30 of which are in the third phase. While Germantown, Tennessee is home to many of these investigations, 5783 sites across the world have studies for this medication running too."

Answered by AI

How many participants are engaged in this clinical trial?

"Indeed, the research hosted on clinicaltrials.gov indicates that this medical trial started recruiting participants on March 7th 2022 and is still actively doing so. The team needs to enroll thirty individuals across one site."

Answered by AI
~18 spots leftby Dec 2025