Ongoing Clinical Trials for Testosterone Deficiency Syndrome
Currently, there is 1 ongoing clinical trial investigating testosterone replacement therapy for men with testosterone deficiency syndrome, specifically focusing on patients with prostate cancer undergoing surgical treatment. This trial is being conducted in the Netherlands and examines whether testosterone therapy can improve sexual function and quality of life following prostate removal surgery.
Clinical trial locations
- Netherlands
Study on Testosterone Therapy for Men with Low Testosterone and Prostate Cancer Undergoing Surgery
This trial is investigating the use of testosterone replacement therapy in men who have both low testosterone levels and prostate cancer. The study specifically focuses on patients who are scheduled to undergo radical prostatectomy, which is a surgical procedure to remove the prostate gland.
Main inclusion criteria:
- Male patients over 18 years of age
- Confirmed diagnosis of non-metastatic prostate cancer (cancer that has not spread to other parts of the body)
- Scheduled for radical prostatectomy with nerve-sparing technique
- Testosterone deficiency confirmed by blood tests on two separate occasions, with total testosterone below 8 nmol/l, or between 8-12 nmol/l with free testosterone below 225 pmol/l
- A minimum score of 40 points on the sexual functioning section of the EPIC-26 quality of life questionnaire
- Specific cancer characteristics including pT2-pT3a stage and ISUP grade 1-3, or ISUP 4-5 with negative surgical margins
- Undetectable PSA levels at 4-week follow-up after surgery
Main exclusion criteria:
- Female patients
- Patients without late-onset hypogonadism (the medical term for testosterone deficiency that develops with aging)
- Patients not undergoing radical prostatectomy
- Patients without testosterone deficiency
- Patients belonging to vulnerable populations who may have limited ability to protect their own interests
Focus and goal of the trial:
The primary goal of this study is to determine whether testosterone replacement therapy can improve sexual function in men with low testosterone who are undergoing prostate removal surgery. Participants will be monitored for 12 months after surgery to assess changes in their sexual health, with additional follow-up continuing for up to 24 months. The study will also evaluate other important aspects of health, including urinary function and hormone levels.
The trial uses a comparison approach where participants are randomly assigned to receive either the active testosterone treatment or a placebo (an inactive gel that looks identical but contains no medication). This design helps researchers determine whether any improvements are truly due to the testosterone therapy rather than other factors.
Investigational drug:
The treatment being tested is Androgel 16.2 mg/g, a gel containing testosterone that is applied daily to the skin. This method of administration, known as transdermal delivery, allows the testosterone to be absorbed through the skin into the bloodstream. The gel is designed to supplement the body’s natural testosterone levels by providing the hormone that the body is not producing in sufficient amounts.
At the molecular level, testosterone binds to androgen receptors throughout the body, which helps maintain male characteristics and various body functions. The therapy is classified as an androgen hormone treatment and is being studied specifically for its potential to improve quality of life outcomes in men with late-onset hypogonadism who are also dealing with prostate cancer treatment.
Summary
The landscape of clinical trials for testosterone deficiency syndrome currently includes one active study being conducted in the Netherlands. This trial represents a focused investigation into a specific patient population: men with both testosterone deficiency and prostate cancer who are undergoing surgical treatment.
The trial addresses an important clinical question about whether testosterone replacement therapy can safely improve sexual function and quality of life in men following prostate cancer surgery. The use of Androgel, a transdermal testosterone gel, reflects a common and convenient method of hormone delivery that allows for steady absorption of the medication.
This research is particularly noteworthy because it examines testosterone therapy in a population that has historically been excluded from such treatment due to concerns about prostate cancer. The careful selection criteria and extended monitoring period demonstrate a thoughtful approach to understanding both the benefits and safety of testosterone therapy in this specific context.