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Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy

ConditionsProstatic NeoplasmsHypogonadismTestosterone Deficiency
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorCanisius-Wilhelmina Hospital

About this trial

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). The negative impact of both TD and RP on sexual performance are likely to add up. The aim of this study is to assess the efficacy and safety of testosterone replacement therapy (TRT) on functional and oncological outcomes in testosterone deficient men following RP for prostate cancer (PCa).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men aged 18 years or older

Histologically confirmed prostate cancer

Radical prostatectomy performed as primary treatment

At least one-sided nerve-sparing procedure performed

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Testosterone gel

    Drug

    Topical gel containing testosterone

  • Placebo

    Drug

    Topical gel without active substance

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Testosterone therapyActive comparator 1 intervention
Group B: Placebo therapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinically relevant (≥12 points) difference in the EPIC-26 sexual functioning domain score, 12 months after radical prostatectomy between groups.

Functional recovery after radical prostatectomy will be assessed by EPIC-26 questionnaire, a Patient Reported Outcome Measure (PROM). Patients will be asked to complete this questionnaire online.

Time frame
12 months

Secondary outcomes

1

Clinically relevant (≥12 points) difference in the EPIC-26 sexual functioning domain score 3 months after radical prostatectomy between groups.

Clinical relevance (\>12 points) for sexual function domain score as measured by EPIC-26.

Time frame
3 months
2

Clinically relevant (≥12 points) difference in the EPIC-26 sexual functioning domain score 24 months after radical prostatectomy between groups.

Clinical relevance (\>12 points) for sexual function domain score as measured by EPIC-26.

Time frame
24 months
3

Clinically relevant (≥9 points) difference in the EPIC-26 urinary incontinence domain score, 12 months after radical prostatectomy between groups.

Clinical relevance (\>9 points) for Urinary incontinence domain score as measured by EPIC-26.

Time frame
12 months
4

Clinically relevant (≥9 points) difference in the EPIC-26 urinary incontinence domain score, 24 months after radical prostatectomy between groups.

Clinical relevance (\>9 points) for Urinary incontinence domain score as measured by EPIC-26.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canisius-Wilhelmina Hospital

Lead sponsor

Besins Healthcare

Collaborator

Source ClinicalTrials.gov
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