Phase 4 Prostate Cancer Trial, Recruiting NCT04373564 Sponsor: Guerbet Condition: Prostate Cancer
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Phase 4 Prostate Cancer Trial, Recruiting

NCT04373564
Recruiting Phase 4

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:

  • People who are neurologically normal — meaning free from unstable neurological or psychiatric conditions, as confirmed by a neurological examination at the start of the trial
  • People who agree to have unenhanced brain MRI scans (MRI scans without contrast dye) at the start of the trial and again after 5 years
  • People who have at least one of the following health situations: medium to high risk for breast cancer or dense breast tissue requiring MRI screening; elevated PSA levels under active monitoring for prostate cancer; chronic liver disease (such as mild liver cirrhosis, post-hepatitis liver conditions, or primary sclerosing cholangitis) being monitored for liver cancer; low-grade colorectal cancer or a type of slow-growing tumour being monitored for spread to the liver; or a specific type of small pancreatic cyst (branch-duct IPMN, no larger than 2 cm) under imaging surveillance

For people joining the contrast dye (GBCA) groups only:

  • People who are likely to have 5 or more MRI scans using the same contrast dye at least once a year over the 5-year study period
  • People who have had up to 3 previous MRI scans using contrast dye before the trial starts may still be eligible, provided the same contrast dye was used and is clearly documented (confirm with trial site)

For people joining the control group (no contrast dye):

  • People who have never received contrast dye in an MRI scan and are unlikely to receive any during the study
  • People willing to have unenhanced brain MRI scans at the start and at year 5, and to continue with their usual clinically recommended scans (MRI without dye, CT, ultrasound, or X-ray) in years 1 through 4

Who may not be able to join:

  • People with a current or past history of certain neurological or psychiatric conditions — including stroke-related brain disease, multiple sclerosis, neurodegenerative disease, epilepsy, prior brain surgery, psychotic disorders, schizophrenia, active or recent major depression or bipolar disorder, uncontrolled severe migraines, uncontrolled or recently treated anxiety or depression (within 6 months of enrolment), certain developmental conditions, or those whose screening test scores fall below a set cognitive threshold (confirm with trial site)
  • People who are currently receiving, have previously received, or are planning to receive chemotherapy or radiation to the brain
  • People taking medications that affect thinking, memory, or movement
  • People with substance or alcohol misuse, as assessed by the trial investigator
  • People whose liver disease is caused by alcohol (alcoholic cirrhosis)
  • People with reduced kidney function, defined by a specific blood test result falling below a set level (confirm with trial site)
  • People with a history of significant exposure to certain harmful chemicals through their environment or work, including heavy metals (such as lead, mercury, or manganese), pesticides, solvents, or carbon monoxide
  • People whose medical condition requires more than one contrast-enhanced MRI scan every 6 months
  • People who are pregnant or breastfeeding
  • People who have metal joint implants or prostheses in their body

For people in the contrast dye (GBCA) groups only:

  • People who have previously received a different contrast dye — or a generic version of a contrast dye — other than the specific one to be used in this trial

For people in the control group only:

  • People who have ever had a contrast dye injection for an MRI scan
  • People who have any reason they cannot safely have an unenhanced MRI scan

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 14 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: +33649351166

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 4
Sponsor
Guerbet
Registry
ClinicalTrials.gov
Start date
24 March 2021
Est. completion
31 December 2028

Where this trial is recruiting

🇧🇷 Brazil 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇷🇺 Russia 🇰🇷 South Korea 🇺🇸 United States

Primary endpoints

Change of motor function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group; Change in cognitive function from baseline to year 5 in comparison to a matched non-GBCA-exposed control group

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: 14 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