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

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Testosterone Gel
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Men aged 18 years or older

• Histologically confirmed prostate cancer

• Radical prostatectomy performed as primary treatment

• At least one-sided nerve-sparing procedure performed

• Non-metastatic disease (cN0M0) based on the use of nomograms or imaging

• Undetectable PSA level (\<0.1 µg/l or unmeasurable according to local protocol) within six weeks following RP

• A preoperative minimal sexual function, defined as a score of 40 points or more (out of 100) for the EPIC-26 sexual function domain

• Testosterone deficiency, defined as total testosterone \<8 nmol/L, or total testosterone between 8-12 nmol/L with free testosterone \<225 pmol/L, measured on two separate occasions, with normal or elevated luteinising hormone (LH)

Locations
Other Locations
Netherlands
Amsterdam UMC location VUmc
RECRUITING
Amsterdam
Netherlands Cancer Institute
RECRUITING
Amsterdam
Rijnstate
RECRUITING
Arnhem
Catharina Hospital
RECRUITING
Eindhoven
Treant
RECRUITING
Emmen
Zuyderland
RECRUITING
Heerlen
St. Antonius Hospital
RECRUITING
Nieuwegein
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Radboud university medical center
RECRUITING
Nijmegen
Máxima Medical Centre
RECRUITING
Veldhoven
Contact Information
Primary
Joost van Drumpt, MSc
enforce@cwz.nl
+31243658190
Time Frame
Start Date: 2022-12-12
Estimated Completion Date: 2029-12
Participants
Target number of participants: 140
Treatments
Active_comparator: Testosterone therapy
Daily application of two pump auctions of 16.2mg/ml testosterone gel. Dosage may be altered depending on clinical response
Placebo_comparator: Placebo therapy
Daily application of two pump auctions of placebo gel.
Sponsors
Collaborators: Besins Healthcare
Leads: Canisius-Wilhelmina Hospital

This content was sourced from clinicaltrials.gov