Phase 3 Prostate Cancer Trial, Recruiting NCT04833426 Sponsor: Canisius-Wilhelmina Hospital Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT04833426
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Men aged 18 years or older
  • People who have been diagnosed with prostate cancer confirmed by a tissue sample (biopsy)
  • People whose primary treatment was surgical removal of the prostate (radical prostatectomy)
  • People whose surgery included a procedure to spare at least one of the nerve bundles near the prostate
  • People whose cancer had not spread to lymph nodes or other parts of the body at the time of surgery, based on scans or other assessments
  • People whose PSA blood test showed an undetectable level within six weeks after surgery, as defined by the local medical team
  • People who had a minimum level of sexual function before surgery, measured by a specific questionnaire score of 40 or more out of 100 (confirm with trial site)
  • People with low testosterone levels, confirmed by two separate blood tests showing specific hormone patterns, alongside normal or elevated levels of a hormone called LH (confirm with trial site for exact values)

Who may not be able to join:

  • People who received any previous treatment for prostate cancer, such as hormone therapy, radiation therapy, or brachytherapy (having been on active surveillance is acceptable)
  • People who have previously used testosterone therapy for any reason
  • People whose removed prostate showed cancer that had spread to certain nearby structures, classified as stage pT3b or pT4 (confirm with trial site)
  • People whose surgical specimen showed cancer cells at the edges of the removed tissue (positive surgical margins) with a high-grade cancer rating of ISUP grade 4 or 5
  • People whose pelvic lymph nodes were removed during surgery and were found to contain cancer
  • People with a history of male breast cancer or a liver tumour
  • People with high blood pressure that is not well controlled
  • People who have a general medical reason that makes testosterone therapy unsuitable for them (confirm with trial site)
  • People who are allergic to any ingredient in the testosterone treatment or the placebo being used in this trial
  • People who take blood-thinning medications known as vitamin K antagonists (such as warfarin)
  • People with a body mass index (BMI) above 30 kg/m²

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Diederik Somford, MD, PhD, Canisius-Wilhelmina Hospital

Phone: +31243658190

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Canisius-Wilhelmina Hospital
Registry
ClinicalTrials.gov
Start date
12 December 2022
Est. completion
1 December 2027

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov