TESTOSTERONE for Late-onset hypogonadism|Non-metastatic prostate cancer

Inclusion criteria

• {"criterion_text":"- Prescreening eligibility criteria 1. Signed informed consent form 1 (IC)\n- Prescreening eligibility criteria 4. Scheduled for radical prostatectomy (RP) as primary treatment with at least one-side nervesparing\n- Prescreening eligibility criteria 5. Non-metastatic disease (cN0M0)\n- Prescreening eligibility criteria 6. Willing to provide two or three (depending on outcome) blood samples to determine testosterone level\n- Prescreening eligibility criteria 7. Willing to use testosterontherapy/placebo by transdermal gel\n- Prescreening eligibility criteria 8. a mimimal sexual functioning of 40 points in the EPIC-26 sexual functioning domain score.\n- 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.\n- Inclusion criteria 8: At least one-sided nerve-sparing procedure.\n- Inclusioncriteria: 2. Signed informed consent form 2 (IC)\n- Inclusioncriteria: 3. Undetectable PSA level at 4-week follow-up\n- Inclusioncriteria: 4. pT2-pT3a on specimen after RP\n- Inclusioncriteria: 5. ISUP 1-3 independent of surgical margin status or ISUP 4-5 with negative surgical margins.\n- Inclusioncriteria: 6. No metastatic lymphnodes in case a pelvic lymphnode dissection has been performed.\n- Inclusioncriteria: 7. No general contra-indications for testosterone\n- Prescreening eligibility criteria 2. Age > 18 years\n- Prescreening eligibility criteria 3. Histologically confirmed prostate cancer"}

Exclusion criteria

• {"criterion_text":"- 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)\n- Prescreening exclusion criteria: 2. Previous use of testosterontherapy for any reason\n- Prescreening exclusion criteria: 3. History of male breast cancer\n- Prescreening exclusion criteria: 4. History of liver tumor\n- Prescreening exclusion criteria: 5. Uncontrolled hypertension\n- Prescreening exclusion criteria: 6. Allergy for components in the testosterone therapy agent or placebo\n- Prescreening exclusion criteria: 7. Use of vitamin-K antagonists (acenocoumarol or fenprocoumon)\n- Prescreening exclusion criteria: 8. metastases (cN1/M1)\n- Prescreening exclusion criteria: 9. BMI > 30"}

Primary endpoints

• {"endpoint_text":"- The main endpoint for this study is the total sexual domain score coming from the EPIC-26 questionnaire, 12 months after radical prostatectomy. A change of 12 points in this domain is considered clinically relevant.","definition_or_measurement_approach":"Measured using the EPIC-26 questionnaire sexual domain score at 12 months after radical prostatectomy; a change of 12 points is considered clinically relevant."}

Secondary endpoints

• {"endpoint_text":"- 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.\n- 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.\n- 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.\n- 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.\n- 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.\n- 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.\n- 7. Occurrence of biochemical recurrence (two times detectable PSA > 0.2 ng/ml)\n- 8. In case of biochemical recurrence, time to recurrence in months.","definition_or_measurement_approach":"EPIC-26 domain scores measured at specified timepoints (6, 12, 24 months); clinically relevant differences defined in text (12 points for sexual domain, 9 points for urinary incontinence, 6 points for hormonal). Biochemical recurrence defined as two times detectable PSA > 0.2 ng/ml; time to recurrence measured in months."}

Other endpoints

• {"endpoint_text":"- Exploratory objective: gain insight on the effect of RP on serum testosterone levels in both patients with normal pre-operative","definition_or_measurement_approach":"Exploratory assessment of serum testosterone levels pre- and post-radical prostatectomy; exact measurement schedule/definition truncated in source."}

Netherlands

Earliest CTIS Part Ii Submission Date

10-12-2024

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

342

Number Of Sites

11

Number Of Participants

140

Primary sponsor

Full Name

Canisius Wilhelmina Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"IKNL","duties_or_roles":"codes: 10,12,5,6,7 (as listed in sponsorDuties)","organisation_type":"Laboratory/Research/Testing facility"}