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Hormone Therapy

Testosterone + Enzalutamide 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

Patient is progressing on continuous androgen ablative therapy

Patient has had prior docetaxel for CSPC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

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.

Who is the study for?

This trial is for men aged 18+ with metastatic castrate resistant prostate cancer who understand the study and consent to participate. They must have a good performance status, measurable disease by CT scan, be on castrating therapy, and show progression despite current treatments. Exclusions include use of certain anticoagulants, uncontrolled health conditions like heart failure or infections (HIV/AIDS), prior treatments for metastatic cancer, or risks from testosterone therapy due to disease location.Check my eligibility

What is being tested?

The trial tests if high doses of oral testosterone undecanoate can maintain serum testosterone levels in these patients over a cycle of seven days on treatment followed by seven off. After three cycles and radiographic scans showing progression, patients switch to enzalutamide for another three cycles with potential continuation based on response.See study design

What are the potential side effects?

Potential side effects may include but are not limited to changes in blood counts or liver enzymes, increased risk of cardiovascular events such as heart attack or stroke due to higher hematocrit levels, worsening symptoms related to sleep apnea or heart failure if pre-existing conditions are present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is getting worse despite hormone therapy.

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I have received docetaxel treatment for prostate cancer.

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My cancer has spread and can be measured on a CT scan.

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I am a man aged 18 or older.

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I can take care of myself but might not be able to do heavy physical work.

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I agree to continue hormone therapy during the trial.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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My prostate cancer is getting worse despite hormone therapy.

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I am currently on prednisone and cannot stop taking it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

2014

Completed Phase 4

~390

Enzalutamide

2014

Completed Phase 4

~2760

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,890 Total Patients Enrolled

56 Trials studying Prostate Cancer

3,318 Patients Enrolled for Prostate Cancer

Clarus TherapeuticsUNKNOWN

2 Previous Clinical Trials

61 Total Patients Enrolled

Samuel Denmeade, MDPrincipal InvestigatorSidney 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

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer

2022. "Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05081193.

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