Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed by a laboratory tissue test — not the small cell or neuroendocrine types.
• People whose surgeon has determined they are a suitable candidate for prostate removal surgery (radical prostatectomy) and who have agreed to have that surgery.
• People whose cancer is classified as high-risk (to begin with) or intermediate-risk (after a safety review has been completed and the lead investigator has confirmed it is safe to include intermediate-risk patients).
• People who can provide a suitable stored tumour tissue sample — either a preserved tissue block or at least 10–15 prepared slides — along with a pathology report; if no stored sample is available, a new biopsy may be needed.
• People who have not received any previous treatment for their prostate cancer (whether whole-body or locally directed).
• People aged 18 years or older.
• People who are generally well enough to carry out everyday activities with little or no limitation (confirm with trial site what this means for specific circumstances).
• People whose blood tests show that their blood cell counts, liver function, kidney function, and blood clotting are all within the acceptable ranges set by the trial.
• People whose testosterone level is above 150 ng/dL.
• People who agree to use effective contraception (such as condoms plus an additional method) during treatment and for four months after the last dose, and who agree not to donate sperm during that period; people with pregnant partners must use condoms for the same period.
• People who are on blood-thinning medication and have been on a stable dose for more than three months.
• People who are able to understand and willing to sign a written informed consent form.
• People who the investigator believes are able to follow the study schedule and requirements.

Who may not be able to join:

• People whose cancer has spread to other parts of the body (metastatic disease), as shown by standard imaging scans.
• People whose surgeon has determined they are not suitable for prostate removal surgery.
• People who have previously received any systemic treatment for prostate cancer, including hormone therapies, chemotherapy, targeted therapy, immunotherapy, or radioactive drug treatments; people taking finasteride or dutasteride may become eligible after stopping the medication and completing a six-week washout period.
• People who have had previous radiation therapy for prostate cancer.
• People with a history of another cancer, with limited exceptions: non-melanoma skin cancer treated with curative intent; certain pre-cancerous conditions (carcinoma-in-situ) with no sign of return for at least three years; appropriately treated early-stage uterine cancer; or other cancers treated with curative intent with no evidence of disease for at least five years.
• People with an active or historical autoimmune disease or immune deficiency condition (such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease, among others) — with some exceptions for well-controlled thyroid conditions, well-controlled diabetes, or certain mild skin conditions that meet specific criteria.
• People with a history of certain lung conditions, including pulmonary fibrosis or drug-related lung inflammation, or who currently have active lung inflammation requiring steroid treatment.
• People who have previously tested positive for HIV.
• People with an active hepatitis B or hepatitis C infection.
• People with serious heart or blood vessel problems, such as a recent heart attack or stroke within the past three months, severe heart failure, unstable irregular heartbeat, or unstable chest pain.
• People with active chronic obstructive pulmonary disease (COPD) requiring home oxygen or daily steroid medication above a certain dose.
• People with asthma requiring daily oral steroid medication above a certain dose (inhaled steroids are acceptable).
• People who have had a major surgical procedure within four weeks before starting the trial, or who are expected to need one during the trial.
• People who have had a serious infection within four weeks before starting the trial, including infections serious enough to require hospitalisation.
• People with any other serious illness, abnormal test results, or health condition that the investigator believes could make trial participation unsafe or affect results.
• People who have previously had a stem cell transplant or received a donor organ transplant.
• People who have received a live vaccine within four weeks before starting the trial, or who are expected to need one during the study or within five months of the last dose of atezolizumab.
• People who have received another experimental (investigational) treatment within 28 days before starting the trial.
• People who have previously received certain types of immunotherapy treatments, including checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies) or related drugs.
• People who have received immune-stimulating medications within four weeks (or longer, depending on the specific drug) before starting the trial.
• People who have received immune-suppressing medications within two weeks before starting the trial, or who are expected to need them during the study — with some exceptions for low-dose or short-term use.
• People with a history of severe allergic reactions to certain laboratory-produced antibody treatments or related proteins.
• People with a known allergy or sensitivity to any of the drugs used in this trial or their ingredients.
• People who have received certain immune cell-targeting therapies within the past five years.
• People who have received intravenous immunoglobulin or plasma exchange treatment within six months before the trial.
• People who have previously been treated with tocilizumab (exceptions may be considered on a case-by-case basis by the study sponsor).
• People who have received certain chemotherapy agents (such as alkylating agents) or total lymphoid irradiation within the past five years.
• People with serious uncontrolled conditions affecting the nervous system, lungs, kidneys, liver, hormonal system (including uncontrolled diabetes), or digestive system.
• People with a recent history of serious bacterial, viral, fungal, or other opportunistic infections.
• People with a primary or secondary immune deficiency condition (unless directly related to the prostate cancer being studied).
• People with any medical or psychological condition that the principal investigator believes could interfere with safely completing the trial.
• People who are pregnant or currently breastfeeding.
• People with nerve damage or other conditions that could affect pain assessment (unless related to their prostate cancer).
• People who do not have adequate vein access for intravenous treatment.
• For one specific group (Cohort B) only: people currently taking certain medications that interact with specific drug-processing pathways in the body, including some heart medications, certain antibiotics, antifungals, and supplements such as St. John's Wort (confirm specific medications with trial site).
• For another specific group (Cohort C) only: people with a known active infection or history of recurring serious infections, including tuberculosis, hepatitis B or C, or shingles (herpes zoster), among others.

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