Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy (ENFORCE)

Conditions

Late-onset hypogonadism

Brief summary

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.

Detailed description

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.

Related papers

No related papers found yet.

Interventions

DRUGplacebo gel

DRUGAndrogel 16

DRUG2 mg/g

DRUGgel

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

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 radical prostatectomy. 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 recurre	—

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 recurre

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Countries

Netherlands

Outcome results

None listed