Prostate Cancer Trial, Recruiting
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:
- You must be over 18 years old.
- You must have been diagnosed with prostate cancer (specifically a type called adenocarcinoma), confirmed by a tissue sample (biopsy).
- Your cancer must have spread to at least one area in the bones, confirmed by a special bone scan; if only one bone lesion is found, it must also be visible on a CT or MRI scan.
- You must be reasonably well and able to carry out daily activities (your doctor will assess this using a standard scale) (confirm with trial site).
- You must have had little or no previous hormone therapy (such as antiandrogens or GnRH analogues) — either none at all, or for no longer than 3 months.
- You must not have had any previous treatment for your prostate cancer, including radiation to the pelvis.
- Your blood test results at the time of screening must meet certain minimum levels for white blood cells, red blood cells, platelets, kidney function, liver function, and protein levels (confirm with trial site).
- You must be able to swallow the study drug (Apalutamide) as a whole tablet.
- You must be willing and able to follow the study rules and sign a consent form agreeing to take part.
- For the surgical part of the trial: you must be over 18, have a specific stage of prostate cancer (stage cT3), and be suitable for a particular type of prostate removal surgery (confirm with trial site).
Who may not be able to join:
- Your prostate cancer is a rare type, such as small cell, ductal, or neuroendocrine prostate cancer.
- Your cancer has spread to the brain.
- Your cancer has only spread to the lymph nodes, with no bone involvement.
- Your cancer has spread to internal organs (such as the liver or lungs).
- You are not considered suitable for surgery or radiotherapy.
- You have had a serious heart or blood vessel problem in the last 6 months, such as a heart attack, unstable chest pain, heart failure, a blood clot (e.g. in the lungs), or a serious abnormal heart rhythm.
- You have high blood pressure that is not well controlled (above 160/100 mmHg).
- You have previously received hormone therapy or any other systemic treatment for prostate cancer.
- You have previously had surgery or radiotherapy to treat your prostate cancer.
- You have had another cancer within the last 5 years (with some exceptions, such as certain treated skin cancers or cancers currently in full remission — confirm with trial site).
- You have a known allergy or sensitivity to any ingredient in the study drug (Apalutamide).
- In the 28 days before joining the trial, you have had a blood transfusion, received growth factor injections to boost blood cell production, or undergone major surgery.
- You have significant liver disease, including chronic viral hepatitis, moderate or severe liver failure, or related complications such as fluid build-up or bleeding disorders.
- You have a stomach or bowel condition that affects how your body absorbs medicines.
- You have an active infection requiring ongoing treatment, such as HIV.
- Your doctor feels that, for any other reason, it would not be appropriate for you to take part in this trial.
- For the surgical part of the trial: you must not have any medical reason that makes surgery unsafe for you.
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.
Contact this trial
Principal Investigator: Valentina Guadalupi, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phone: 00390223903811
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
Where this trial is recruiting
Primary endpoints
Radiographic Progression-Free Survival (rPFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.