Phase 3 Prostate Cancer Trial, Recruiting NCT03819101 Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT03819101
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:

  • People who have been diagnosed with prostate cancer (confirmed by a tissue sample) where curative local treatment is no longer considered possible.
  • People aged 18 or older with a life expectancy of at least 6 months.
  • People whose prostate cancer has continued to grow or spread despite hormone-suppressing treatment (such as surgical removal of the testicles or hormone-blocking injections), with testosterone levels confirmed to be very low. If surgical castration has not been performed, ongoing hormone-suppressing treatment is required.
  • People with or without cancer spread (metastases) visible on imaging scans.
  • People with a general health and activity level rated as reasonably functional (performance status 0, 1, or 2 — confirm with trial site what this means for a specific situation).
  • People who have not previously received life-prolonging treatments for this stage of prostate cancer, such as abiraterone, enzalutamide, radium-223, docetaxel, cabazitaxel, or sipuleucel-T. Use of these treatments at an earlier stage of the disease alongside hormone therapy is acceptable.
  • People with adequate kidney and liver function, confirmed by blood tests taken within 30 days before registration.
  • People who may be participating in other clinical trials, as long as those trials do not share the same primary goal of measuring overall survival.
  • People who meet any country-specific regulations required to participate in a clinical trial (for example, being enrolled in a social security or health insurance system in certain countries).
  • People who have received full information about the trial and have signed a consent form agreeing to participate.

Who may not be able to join:

  • People who have had a localised (non-spreading) cancer diagnosis within the past 2 years, with exceptions for certain early-stage skin cancers and certain early-stage bladder cancers. People with symptom-free chronic lymphocytic leukaemia may still be eligible (confirm with trial site).
  • People who have had a cancer that had spread to other parts of the body within the past 5 years.
  • People who are currently taking daily aspirin (acetylsalicylic acid) or a daily statin medication and have been doing so within the last 6 months.
  • People with active liver disease such as hepatitis B or C, cirrhosis, unexplained persistent high liver enzyme levels, or signs of bile flow problems (cholestasis).
  • People with a history of heavy alcohol use or a significant liver condition.
  • People with a known allergy or intolerance to aspirin, atorvastatin, or any of their ingredients.
  • People for whom aspirin or atorvastatin is medically not recommended, including those considered at high risk of bleeding.
  • People with a history of or currently active muscle disease, or significantly elevated muscle enzyme (CK) levels in the blood.
  • People with a recent history of stroke or a transient ischemic attack (a brief, stroke-like episode).
  • People currently taking certain medications that interact with the trial drugs, including some antibiotics, antifungals, HIV medications, and other specific drugs (confirm the full list with the trial site).
  • People with any serious underlying health condition that the trial doctor believes would prevent safe participation.
  • People with certain rare inherited conditions affecting the body's ability to process specific sugars (hereditary galactose intolerance, Lapp-lactase deficiency, or glucose-galactose malabsorption).
  • People for whom attending regular medical follow-up appointments would not be possible due to geographic, social, or personal circumstances.
  • People with a psychiatric condition that would prevent them from understanding the trial, giving informed consent, or reliably taking oral medications as required.

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 20 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

Phone: +33 (0)1 42 11 43 17

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
Gustave Roussy, Cancer Campus, Grand Paris
Registry
ClinicalTrials.gov
Start date
6 June 2019
Est. completion
1 March 2042

Where this trial is recruiting

🇨🇿 Czechia 🇫🇷 France 🇮🇹 Italy 🇸🇰 Slovakia 🇨🇭 Switzerland Tunisia

Primary endpoints

Overall Survival (OS)

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: 20 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