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Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy
EU CTIS ID: 2024-511340-29-02
What this study is testing
Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP, leads to better outcomes in the domain of sexual functioning 12 months after Radical Prostatectomy (RP) compared to testosterone deficient men who receive placebo therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Prescreening eligibility criteria 1. Signed informed consent form 1 (IC)
- Prescreening eligibility criteria 4. Scheduled for radical prostatectomy (RP) as primary treatment with at least one-side nervesparing
- Prescreening eligibility criteria 5. Non-metastatic disease (cN0M0)
- Prescreening eligibility criteria 6. Willing to provide two or three (depending on outcome) blood samples to determine testosterone level
- Prescreening eligibility criteria 7. Willing to use testosterontherapy/placebo by transdermal gel
- Prescreening eligibility criteria 8. a mimimal sexual functioning of 40 points in the EPIC-26 sexual functioning domain score.
You likely can't join if
- Prescreening exclusion criteria: 1. Any previous treatment for prostate cancer, for example but not limited to: anti-hormonal therapy, radiotherapy, brachytherapy (active surveillance is allowed)
- Prescreening exclusion criteria: 2. Previous use of testosterontherapy for any reason
- Prescreening exclusion criteria: 3. History of male breast cancer
- Prescreening exclusion criteria: 4. History of liver tumor
- Prescreening exclusion criteria: 5. Uncontrolled hypertension
- Prescreening exclusion criteria: 6. Allergy for components in the testosterone therapy agent or placebo
See the full eligibility criteria
- Prescreening eligibility criteria 1. Signed informed consent form 1 (IC)
- Prescreening eligibility criteria 4. Scheduled for radical prostatectomy (RP) as primary treatment with at least one-side nervesparing
- Prescreening eligibility criteria 5. Non-metastatic disease (cN0M0)
- Prescreening eligibility criteria 6. Willing to provide two or three (depending on outcome) blood samples to determine testosterone level
- Prescreening eligibility criteria 7. Willing to use testosterontherapy/placebo by transdermal gel
- Prescreening eligibility criteria 8. a mimimal sexual functioning of 40 points in the EPIC-26 sexual functioning domain score.
- Inclusioncriteria: 1. Testosterone deficiency: total testosterone < 8nmol/l OR total testosterone 8-12 nmol/l and free testosterone < 225 pmol/l, measured at two separate occasions and normal or elevated LH.
- Inclusion criteria 8: At least one-sided nerve-sparing procedure.
- Inclusioncriteria: 2. Signed informed consent form 2 (IC)
- Inclusioncriteria: 3. Undetectable PSA level at 4-week follow-up
- Inclusioncriteria: 4. pT2-pT3a on specimen after RP
- Inclusioncriteria: 5. ISUP 1-3 independent of surgical margin status or ISUP 4-5 with negative surgical margins.
- Inclusioncriteria: 6. No metastatic lymphnodes in case a pelvic lymphnode dissection has been performed.
- Inclusioncriteria: 7. No general contra-indications for testosterone
- Prescreening eligibility criteria 2. Age > 18 years
- Prescreening eligibility criteria 3. Histologically confirmed prostate cancer
- Prescreening exclusion criteria: 1. Any previous treatment for prostate cancer, for example but not limited to: anti-hormonal therapy, radiotherapy, brachytherapy (active surveillance is allowed)
- Prescreening exclusion criteria: 2. Previous use of testosterontherapy for any reason
- Prescreening exclusion criteria: 3. History of male breast cancer
- Prescreening exclusion criteria: 4. History of liver tumor
- Prescreening exclusion criteria: 5. Uncontrolled hypertension
- Prescreening exclusion criteria: 6. Allergy for components in the testosterone therapy agent or placebo
- Prescreening exclusion criteria: 7. Use of vitamin-K antagonists (acenocoumarol or fenprocoumon)
- Prescreening exclusion criteria: 8. metastases (cN1/M1)
- Prescreening exclusion criteria: 9. BMI > 30
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.