Study on Testosterone Therapy for Men with Low Testosterone and Prostate Cancer Undergoing Surgery

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What is this study about?

This clinical trial is focused on studying the effects of testosterone replacement therapy (TRT) in men with prostate cancer who have low levels of testosterone, a condition known as late-onset hypogonadism. The treatment being tested is a gel called Androgel, which contains testosterone. The study will compare the outcomes of men who receive this testosterone gel with those who receive a placebo gel, which does not contain any active medication.

The purpose of the study is to determine if using testosterone gel can improve sexual function in men who are undergoing a surgical procedure called radical prostatectomy, which is the removal of the prostate gland. Participants will be monitored for 12 months after their surgery to assess changes in their sexual health. The study will also look at other aspects of health, such as urinary function and hormone levels, over a period of up to 24 months.

Participants in the study will apply the gel to their skin, a method known as transdermal use. The study aims to provide insights into whether testosterone therapy can lead to better health outcomes for men with prostate cancer who have low testosterone levels. The findings could help guide future treatments for improving quality of life in these patients.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding and agreement to participate in the clinical trial.

2 initial assessment

You will undergo an initial assessment to confirm eligibility. This includes providing blood samples on two separate occasions to measure your testosterone levels. The study requires that your total testosterone level is below 8 nmol/l, or between 8-12 nmol/l with free testosterone below 225 pmol/l.

3 treatment allocation

You will be randomly assigned to receive either Androgel 16.2 mg/g, gel or a placebo gel. The gel is applied to the skin, a method known as transdermal use.

4 treatment administration

You will apply the assigned gel daily as instructed. The duration of this treatment will be determined by the study protocol and will continue through the peri-operative period of your prostate surgery.

5 surgery and follow-up

You will undergo a radical prostatectomy, which is a surgical procedure to remove the prostate gland. After surgery, your progress will be monitored, and you will have follow-up visits to assess your recovery and the impact of the treatment on your sexual and urinary functions.

6 evaluation of outcomes

Your sexual functioning will be evaluated using the EPIC-26 questionnaire at 6, 12, and 24 months after surgery. This questionnaire measures various aspects of your health and quality of life. A change in scores will help determine the effectiveness of the treatment.

7 completion of the study

The study will conclude after the final assessments are completed. Your participation will contribute to understanding the impact of testosterone therapy on outcomes following prostate surgery.

Who Can Join the Study?

Must be a male patient.
Must be over 18 years old.
Must have a confirmed diagnosis of prostate cancer.
Must be scheduled for a radical prostatectomy (RP), which is a surgery to remove the prostate gland, with at least one side of the nerves being spared.
Must have non-metastatic disease, meaning the cancer has not spread to other parts of the body.
Must be willing to provide blood samples to check testosterone levels.
Must be willing to use testosterone therapy or a placebo through a gel applied to the skin.
Must have a minimum score of 40 points in the sexual functioning section of the EPIC-26 questionnaire, which measures quality of life related to prostate cancer.
Must have testosterone deficiency, defined as total testosterone less than 8 nmol/l or total testosterone between 8-12 nmol/l with free testosterone less than 225 pmol/l, measured on two separate occasions, and normal or elevated LH (a hormone).
Must have an undetectable PSA level at a 4-week follow-up. PSA is a protein produced by the prostate, and low levels can indicate successful treatment.
Must have a pT2-pT3a classification on the specimen after RP, which refers to the stage of the cancer.
Must have an ISUP grade of 1-3, regardless of surgical margin status, or ISUP 4-5 with negative surgical margins. ISUP is a grading system for prostate cancer.
Must have no metastatic lymph nodes if a pelvic lymph node dissection was performed.
Must have no general contraindications for testosterone therapy, meaning there should be no medical reasons that would prevent the use of testosterone.
Must sign an informed consent form to participate in the study.

Who Cannot Join the Study?

Patients who are not men cannot participate.
Patients who are not experiencing late-onset hypogonadism cannot participate. Hypogonadism is a condition where the body doesn’t produce enough testosterone.
Patients who are not undergoing Radical Prostatectomy (RP) cannot participate. Radical Prostatectomy is a surgery to remove the prostate gland.
Patients who are not testosterone deficient cannot participate. Testosterone deficiency means having lower than normal levels of testosterone, a hormone important for male development and health.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands

Other Sites

Site Name	City	Country
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Stichting Treant Ziekenhuiszorg	Emmen	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Rtffrxbyg Zpvolrsgmz Stmmksvit	Arnhem	The Netherlands
Aojmitgza Urp	Amsterdam	The Netherlands
Ssmdzvykf Rodloxk Uhldahsdld Mvrmnfg Csbhfx	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.11.2022

Trial locations

Investigated drugs:

Testosterone

Testosterone Replacement Therapy (TRT) is a treatment used to increase testosterone levels in men who have low testosterone. In this clinical trial, TRT is being studied to see if it can improve sexual function in men with prostate cancer who are undergoing surgery to remove the prostate. The therapy aims to help these men feel better and have better sexual health after their surgery.

Investigated diseases:

Hypogonadism male

Late-onset hypogonadism – Late-onset hypogonadism is a condition characterized by a decrease in testosterone production in aging men. This decline in hormone levels can lead to various symptoms, including reduced libido, fatigue, and mood changes. As the condition progresses, individuals may experience a decrease in muscle mass and bone density, as well as an increase in body fat. The progression of symptoms can vary widely among individuals, with some experiencing more pronounced effects than others. The condition is often associated with other age-related health issues, which can complicate its progression.

Trial ID:

2024-511340-29-02

NCT ID:

NCT04833426

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Testosterone Therapy for Men with Low Testosterone and Prostate Cancer Undergoing Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?