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

NCT04833426 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-02

No results posted yet for this study

Summary

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).

Conditions

  • Prostatic Neoplasms
  • Hypogonadism
  • Testosterone Deficiency

Interventions

DRUG

Testosterone gel

Topical gel containing testosterone

DRUG

Placebo

Topical gel without active substance

Sponsors & Collaborators

  • Besins Healthcare

    collaborator INDUSTRY

  • Canisius-Wilhelmina Hospital

    lead OTHER

Principal Investigators

  • Diederik Somford, MD, PhD · Canisius-Wilhelmina Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04833426 on ClinicalTrials.gov