Phase 3 Prostate Cancer Trial, Recruiting NCT06585007 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT06585007
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:

  • Written agreement to take part in the trial has been provided by the person or their legal representative before any screening begins.
  • The person has a specific type of prostate cancer called acinar adenocarcinoma (including cases where the cancer cells have changed in a particular way called neuro-endocrine dedifferentiation).
  • The cancer is "oligoprogressive," meaning only a small number of areas (up to 3 spots outside the brain) are growing or newly appeared on scans taken within 6 weeks before joining the trial (confirm with trial site for full imaging details).
  • The person falls into one of two groups: either their prostate cancer is being managed with ongoing hormone therapy alone (Type 1), or with hormone therapy plus an additional drug or past chemotherapy with docetaxel (Type 2).
  • The cancer is no longer responding to hormone therapy, shown by a very low testosterone level in the blood (below 50 ng/dL).
  • The original prostate tumor was previously treated with radiotherapy or surgery — or that treatment will be given as part of the trial if it has not yet been done.
  • The person has a general health and activity level rated as 0, 1, or 2 on the WHO performance scale (meaning they are able to carry out at least some daily activities).
  • The person is 18 years of age or older.
  • There are no major psychological, social, or location-related factors that would make it difficult to follow the trial's requirements.
  • The person's case has been reviewed and approved by a specialist multidisciplinary medical team.

Who may not be able to join:

  • People with a different type of prostate cancer called ductal adenocarcinoma or small-cell prostate cancer.
  • People whose testosterone level is above 50 ng/mL in the blood.
  • People whose cancer is "poly-progressive," meaning more than 3 areas are growing or spreading on scans.
  • People who have another active cancer (other than prostate cancer) that could affect how trial results are interpreted.
  • People whose previous cancer treatments or other health conditions mean that a type of targeted radiation treatment called SBRT cannot safely be given.
  • People with a spinal bone lesion that is causing significant pain, threatening nerve function, or at high risk of breaking.
  • People who have previously been treated with radionuclide therapy, cabazitaxel, or PARP-inhibitor drugs.
  • People whose cancer was growing while they were receiving docetaxel chemotherapy.
  • People who are not able to understand the trial procedures or provide signed consent.

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 19 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: Gert De Meerleer, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Phone: 003216347600

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
Registry
ClinicalTrials.gov
Start date
19 December 2023
Est. completion
20 January 2029

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Overall Survival

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: 19 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