30 Participants Needed

Testosterone Therapy for Prostate Cancer

MD
Overseen ByMichael D Wacker
Age: 18+
Sex: Male
Trial Phase: Phase < 1
Sponsor: University of Colorado, Denver
Must be taking: GnRH analogue
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

If you are on a first-generation anti-androgen medication, you must stop taking it at least 6 weeks before starting the trial. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment Enzalutamide, Xtandi, and Transdermal Testosterone for prostate cancer?

Recent studies suggest that testosterone therapy, once thought to be unsafe for men with prostate cancer, is now considered a viable option for treating testosterone deficiency in these patients. This shift is based on evidence showing that testosterone therapy can be safe and beneficial, improving well-being and physical strength, although careful monitoring is necessary to ensure prostate safety.12345

Is testosterone therapy safe for people with prostate cancer?

Testosterone therapy has been studied for safety in men with prostate cancer, and while short-term use appears safe, there are concerns about long-term risks, especially regarding prostate health. More large, long-term studies are needed to fully understand the safety of testosterone therapy in this group.56789

How does the treatment Transdermal Testosterone differ from other treatments for prostate cancer?

Transdermal Testosterone is unique because it challenges the traditional belief that testosterone therapy is unsafe for men with prostate cancer. Recent studies suggest that it can be safely used in men with prostate cancer, potentially improving their quality of life by addressing symptoms of low testosterone (hypogonadism) without significantly increasing cancer risk.1281011

Research Team

LG

Laura Graham

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Inclusion Criteria

Provision to sign and date the consent form
Progressive disease at screening as defined by one or more of the following criteria:
My prostate cancer was confirmed by a lab test.
See 17 more

Exclusion Criteria

I have stomach or intestine problems that could affect medicine absorption.
I have not had a heart attack in the last 6 months.
I have had a seizure before or lost consciousness/had a mini-stroke in the last year.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transdermal testosterone alternating with enzalutamide

12 months
Visits every four weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Enzalutamide
  • Transdermal Testosterone
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Cancer League of Colorado

Collaborator

Trials
13
Recruited
450+

Findings from Research

Recent evidence indicates that testosterone therapy in men with prostate cancer does not increase the risk of cancer progression or aggressive disease, challenging previous beliefs about its safety.
Men undergoing testosterone therapy for localized prostate cancer showed no higher rates of recurrence or adverse clinical outcomes, suggesting that testosterone treatment may be a viable option for those with testosterone deficiency.
Testosterone Therapy on Active Surveillance and Following Definitive Treatment for Prostate Cancer.Golla, V., Kaplan, AL.[2022]
Recent literature indicates that testosterone therapy does not increase the risk of prostate cancer or lead to more aggressive disease in men with testosterone deficiency, challenging the long-held belief that higher testosterone levels promote cancer growth.
Men with a history of localized prostate cancer who receive testosterone therapy do not experience higher rates of cancer recurrence or worse outcomes, suggesting that testosterone therapy can be a safe and effective option for managing testosterone deficiency in this population.
Testosterone Therapy in Men With Prostate Cancer.Kaplan, AL., Hu, JC., Morgentaler, A., et al.[2018]
Testosterone therapy can significantly improve well-being, muscle and bone mass, strength, and libido in men with late-onset hypogonadism, but achieving optimal therapy remains challenging due to the limitations of oral testosterone delivery.
While current evidence suggests testosterone therapy is safe, it is crucial to monitor prostate health through digital rectal exams and PSA levels, especially during the first 3-6 months of treatment, to mitigate the risk of promoting pre-existing prostate cancer.
The current status of therapy for symptomatic late-onset hypogonadism with transdermal testosterone gel.Ebert, T., Jockenhövel, F., Morales, A., et al.[2013]

References

Testosterone Therapy on Active Surveillance and Following Definitive Treatment for Prostate Cancer. [2022]
Testosterone Therapy in Men With Prostate Cancer. [2018]
Association between Basal Total Testosterone Levels and Tumor Upgrading in Low and Intermediate Risk Prostate Cancer. [2018]
The current status of therapy for symptomatic late-onset hypogonadism with transdermal testosterone gel. [2013]
Testosterone Replacement Therapy in Men with Untreated or Treated Prostate Cancer: Do We Have Enough Evidences? [2021]
The effect of androgen supplementation therapy on the prostate. [2013]
Testosterone therapy does not increase the risks of prostate cancer recurrence or death after definitive treatment for localized disease. [2021]
The Role of Testosterone Therapy in the Setting of Prostate Cancer. [2018]
The relationship between total testosterone levels and prostate cancer: a review of the continuing controversy. [2022]
Testosterone Therapy in a Man with Intermediate-risk Prostate Cancer: Pro. [2021]
Testosterone Therapy After Prostate Cancer Treatment: A Review of Literature. [2021]