NCT04833426

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
44mo left

Started Dec 2022

Longer than P75 for phase_3

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Dec 2022Dec 2029

First Submitted

Initial submission to the registry

February 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 2, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

February 5, 2021

Last Update Submit

May 1, 2025

Conditions

Prostatic NeoplasmsHypogonadismTestosterone Deficiency

Keywords

Prostate cancerProstatectomyHypogonadismTestosterone deficiency

Outcome Measures

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.

    12 months

Secondary Outcomes (7)

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

    3 months

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

    24 months

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

    12 months

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

    24 months

  • Clinically relevant (≥6 points) difference in the EPIC-26 for hormonal functioning domain score, 12 months after radical prostatectomy between groups.

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Testosterone therapy

ACTIVE COMPARATOR

Daily application of two pump auctions of 16.2mg/ml testosterone gel. Dosage may be altered depending on clinical response

Drug: Testosterone gel

Placebo therapy

PLACEBO COMPARATOR

Daily application of two pump auctions of placebo gel.

Drug: Placebo

Interventions

Testosterone gelDRUG

Topical gel containing testosterone

Also known as: Androgel
Testosterone therapy
PlaceboDRUG

Topical gel without active substance

Also known as: Placebo gel
Placebo therapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Presence of metastatic lymph nodes if pelvic lymph node dissection was performed
  • History of male breast cancer or liver tumour
  • Uncontrolled hypertension
  • General contraindications for TRT
  • Allergy for components in TRT agent or placebo
  • Use of vitamin K antagonists
  • Body mass index (BMI) \>30 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Amsterdam UMC location VUmc

Amsterdam, Netherlands

RECRUITING

Netherlands Cancer Institute

Amsterdam, Netherlands

RECRUITING

Rijnstate

Arnhem, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, Netherlands

RECRUITING

Treant

Emmen, Netherlands

RECRUITING

Zuyderland

Heerlen, Netherlands

RECRUITING

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, 6532 SZ, Netherlands

RECRUITING

Radboud university medical center

Nijmegen, Netherlands

RECRUITING

Máxima Medical Centre

Veldhoven, Netherlands

RECRUITING

Related Publications (1)

  • Baas D, van Drumpt J, Kiemeney L, Beck J, Ostergren PB, Sedelaar M, Hoekstra R, Spruyt AB, van Melick H, Bruins M, van Leeuwen P, Vis A, Wijburg C, Roelofs L, van den Bergh R, van Soest R, van Basten JP, Somford D. Clinical Trial Protocol: Impact of Testosterone Replacement Therapy on Functional and Oncological Outcomes Following Radical Prostatectomy (ENFORCE Study). Eur Urol Oncol. 2025 Jun 12:S2588-9311(25)00168-3. doi: 10.1016/j.euo.2025.05.024. Online ahead of print.

    PMID: 40514343DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsHypogonadism

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Diederik Somford, MD, PhD

    Canisius-Wilhelmina Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost van Drumpt, MSc

CONTACT

+31243658190enforce@cwz.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

April 6, 2021

Study Start

December 12, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Last Updated

May 2, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(10)