← Back to Search

Hormone Therapy

Testosterone Therapy for Prostate Cancer

Phase < 1
Waitlist Available
Led By Elizabeth Kessler, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Soft tissue progression on CT or MRI based on RECIST 1.1 criteria or progression of bone disease according to PCWG3 criteria
Histologically or cytologically proven adenocarcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study start date to study end date, up to 12 months, or until patient death
Awards & highlights

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.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to castration therapy can join. They must have been on hormone therapy for at least 6 months, show PSA progression despite treatment, and not be in severe pain or on daily narcotics. Participants need normal organ function tests and agree to use two forms of birth control if applicable.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of applying testosterone through the skin alternated with a drug called Enzalutamide. It aims to see if this approach is feasible for men whose prostate cancer has stopped responding to standard hormonal treatments.See study design
What are the potential side effects?
Potential side effects may include changes in mood or energy levels due to testosterone, plus any known risks from Enzalutamide such as fatigue, high blood pressure, or falls. There might also be an increased risk of cardiovascular issues due to fluctuating testosterone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has grown or spread according to recent scans.
Select...
My prostate cancer was confirmed by a lab test.
Select...
I have been on hormone therapy for prostate cancer for at least 6 months.
Select...
I am a man and will use two forms of birth control, including condoms, with my partner during and 3 months after the study.
Select...
I have stopped taking first-generation anti-androgen drugs for at least 6 weeks and my PSA levels are still rising.
Select...
I am a man and at least 18 years old.
Select...
I have received multiple treatments for my castration-resistant condition.
Select...
My worst pain in the last day was less than 4 out of 10, and I don't take daily painkillers for cancer pain.
Select...
My cancer has spread, shown by scans or previous tests.
Select...
I am a man and at least 18 years old.
Select...
My scans show my cancer has grown or spread.
Select...
I stopped taking first-generation anti-androgen drugs 6 weeks ago and my PSA levels are still rising.
Select...
I have been on hormone therapy for prostate cancer for at least 6 months.
Select...
My prostate cancer was confirmed by a lab test.
Select...
My cancer has spread, shown by scans or previous tests.

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

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 Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,646 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 InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
19 Total Patients Enrolled

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, 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
~2 spots leftby Aug 2024