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Hormone Therapy

Transdermal Testosterone for Prostate Cancer

University of Colorado Hospital, Aurora, CO
Targeting 2 different conditionsTransdermal Testosterone +1 morePhase < 1RecruitingLed by Elizabeth Kessler, MDResearch Sponsored by University of Colorado, Denver

Study Summary

This trial is testing a possible new treatment for prostate cancer that could be more effective and have fewer side effects than current options.

Eligible Conditions
  • Castration-resistant Prostate Cancer
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have received treatment for advanced cancer that is resistant to hormone therapy.
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If you have sex with a pregnant woman, you must use a condom.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study start date to study end date, up to 12 months, or until patient death
This trial's timeline: 3 weeks for screening, Varies for treatment, and study start date to study end date, up to 12 months, or until patient death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of the Administration of Transdermal Testosterone Alternating with Enzalutamide
Secondary outcome measures
Body Composition
Bone Health
Change in Hormones
+15 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.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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: Square Wave Testosterone Therapy + SOCExperimental Treatment2 Interventions
All patients will receive transdermal testosterone. All patients will also receive standard of care enzalutamide. Patients will alternate between the two therapies.

Find a site

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,673 Previous Clinical Trials
1,662,241 Total Patients Enrolled
13 Trials studying Prostate Cancer
2,996 Patients Enrolled for Prostate Cancer
Cancer League of ColoradoOTHER
7 Previous Clinical Trials
196 Total Patients Enrolled
Elizabeth Kessler, MDPrincipal Investigator
University of Colorado, Denver
1 Previous Clinical Trials
19 Total Patients Enrolled
Laura Graham, MDPrincipal Investigator
University of Colorado, Denver

Media Library

Transdermal Testosterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03734653 — Phase < 1
Prostate Cancer Research Study Groups: Square Wave Testosterone Therapy + SOC
Prostate Cancer Clinical Trial 2023: Transdermal Testosterone Highlights & Side Effects. Trial Name: NCT03734653 — Phase < 1
Transdermal Testosterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03734653 — Phase < 1

Frequently Asked Questions

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

Am I qualified to participate in this experiment?

"This clinical trial is recruiting participants with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), aged 18 and over. The requisite criteria that must be met include: willingness to commit to the study's duration; a 6-week gap between stopping first-generation anti-androgens and randomization; worst pain in last 24 hours rated at 4 or below on a 0 to 10 scale; no daily use of narcotics for treating cancer-related pain (assessment during screening window to be documented); male gender; age 18 years old or older."

Answered by AI

How many participants are conducting this research study?

"This clinical trial has halted participant recruitment for the time being. Initially published on January 18th 2019, this study was last amended on May 12th 2022. As an alternative, there are a total of 1324 trials recruiting prostate cancer patients and 126 studies in need of volunteers to test Transdermal Testosterone."

Answered by AI

Could you elucidate other research endeavors that have explored Transdermal Testosterone?

"Currently, 126 clinical trials for transdermal testosterone are ongoing and 35 of these studies have reached their third phase. The majority of the investigations are located in Germantown, Tennessee yet a total of 5863 sites nationwide feature this medication trial."

Answered by AI

Does this research endeavor currently require any new participants?

"Unfortunately, this medical trial is not currently open to recruitment. It was first advertised on January 18th 2019 and the latest update occurred on May 12th 2022. However, there are 1,324 trials recruiting for prostate cancer treatment and 126 studies searching for participants with Transdermal Testosterone issues."

Answered by AI

Does this research involve minors under the age of 20?

"This study is currently seeking patients that are of legal age (18+) and under the century mark."

Answered by AI

In what cases is Transdermal Testosterone typically administered?

"Sufferers of hypogonadotropic hypogonadism, post-menopausal women with 1 to 5 years since last period and orchidectomy can all benefit from the use of Transdermal Testosterone."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testosterone Therapy in Castration Resistant Prostate Cancer
2019. "Testosterone Therapy in Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03734653.
~4 spots leftby Aug 2024
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