BridgeMD
New treatment option for Prostatic Neoplasms
Official title Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy
ClinicalTrials.gov ID: NCT04833426
What this study is testing
What is Testosterone gel?
Testosterone gel is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for prostatic neoplasms.
Also referred to as Androgel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sexual dysfunction is a common side effect of radical prostatectomy (RP) and has a significant negative impact on quality of life. With age the testosterone level in men declines; around 30% of men over 70 years of age meet the criteria of testosterone deficiency (TD).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Men aged 18 years or older
- Histologically confirmed prostate cancer
- Radical prostatectomy performed as primary treatment
- At least one-sided nerve-sparing procedure performed
- Non-metastatic disease (cN0M0) based on the use of nomograms or imaging
You likely can't join if
- Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
- Previous use of testosterone therapy for any reason
- Pathological stage pT3b or pT4 in the RP specimen
- Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen
- Presence of metastatic lymph nodes if pelvic lymph node dissection was performed
- History of male breast cancer or liver tumour
See the full eligibility criteria
- Men aged 18 years or older
- Histologically confirmed prostate cancer
- Radical prostatectomy performed as primary treatment
- At least one-sided nerve-sparing procedure performed
- Non-metastatic disease (cN0M0) based on the use of nomograms or imaging
- Undetectable PSA level (\<0.1 µg/l or unmeasurable according to local protocol) within six weeks following RP
- A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain
- Testosterone deficiency, defined as total testosterone \<8 nmol/L, or total testosterone between 8-12 nmol/L with free testosterone \<225 pmol/L, measured on two separate occasions, with normal or elevated luteinising...
- Prior prostate cancer treatment, including but not limited to anti-hormonal therapy, radiotherapy, or brachytherapy (active surveillance allowed)
- Previous use of testosterone therapy for any reason
- Pathological stage pT3b or pT4 in the RP specimen
- Positive surgical margin(s) with ISUP grade 4 or 5 in the RP specimen
- Presence of metastatic lymph nodes if pelvic lymph node dissection was performed
- History of male breast cancer or liver tumour
- Uncontrolled hypertension
- General contraindications for TRT
- Allergy for components in TRT agent or placebo
- Use of vitamin K antagonists
- Body mass index (BMI) \>30 kg/m²
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Arnhem, Netherlands
- Eindhoven, Netherlands
- Emmen, Netherlands
- Heerlen, Netherlands
- Nieuwegein, Netherlands
- Nijmegen, Netherlands
- Veldhoven, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Arnhem, Netherlands; Eindhoven, Netherlands; Emmen, Netherlands; Heerlen, Netherlands; Nieuwegein, Netherlands and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.