Late-onset Hypogonadism testosterone deficiency
Conditions
Interventions
randomization between testosterongel or placebo.
Sponsors
Canisius Wilhelmina Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form 1 (IC) 2. Age > 18 years 3. Histologically confirmed prostate cancer 4. Scheduled for RP as primary treatment with at least one-side nervesparing. 5. Non-metastatic disease (cN0M0) 6. Willing to provide blood samples to determine testosterone level 7. Signed informed consent form 2 (ICF) 8. Undetectable PSA level at 4-week follow-up 9. Willing to use testosterone gel or placebo gel 10. a minimal score of 40 points for the EPIC-26 sexual domain.
Exclusion criteria
Exclusion criteria: 1. Any previous treatment for prostate cancer, for example but not limited to: anti-hormonal therapy, radiotherapy, brachytherapy (active surveillance is allowed). 2. Previous use of TRT for any reason 3. History of male breast cancer 4. History of liver tumor 5. Uncontrolled hypertension 6. Allergy for components in the testosterone therapy agent or placebo 7. Use of vitamin-K antagonists (acenocoumarol or fenprocoumon) 8. pT3b or pT4 9. Positive surgical margin (PSM) and ISUP 4 or 5 (ISUP 1 to 3 with PSM and ISUP 4 or 5 without PSM can be included). 10. Metastatic lymph nodes if a PLND has been done 11. BMI > 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint for this study is the total sexual domain score coming from the EPIC-26 questionnaire, 12 months after RP. Calculation of this domain score is done by calculating the average of the Standardized Values for items 57-60, 64 and 68 (with 5 non-missing items needed to compute score). Corresponding with questions 8a, 8b, 9, 10, 11 and 12. This results in a number between 0 and 100. A change of 12 points in this domain is considered clinically relevant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. EPIC-26 sexual functioning domain score [0-100] at 6 months after RP. A difference of 12 points or more is considered clinically relevant. 2. EPIC-26 sexual functioning domain score [0-100] at 24 months after RP. A difference of 12 points or more is considered clinically relevant. 3. EPIC-26 urinary incontinence domain score [0-100] at 12 months after RP. A difference of 9 points or more is considered clinically relevant. 4. EPIC-26 urinary incontinence domain score [0-100] at 24 months after RP. A difference of 9 points or more is considered clinically relevant. 5. EPIC-26 hormonal functioning domain score [0-100] at 12 months after RP. A difference of 6 points or more is considered clinically relevant. 6. EPIC-26 hormonal functioning domain score [0-100] at 24 months after RP. A difference of 6 points or more is considered clinically relevant. 7. Occurrence of biochemical recurrence (two times detectable PSA > 0.2 ng/ml) 8. In case of biochemical recurrence, time to recurrence in months. | — |
Countries
Netherlands
Outcome results
None listed