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:

• Men aged 18 or older.
• People who are able to give written consent and follow the study procedures.
• People with advanced or metastatic prostate cancer (adenocarcinoma type, confirmed by tissue or cell testing), without small cell or neuroendocrine features.
• People on androgen deprivation therapy (hormone therapy) combined with a prostate cancer hormone-blocking drug, whose testosterone blood levels are at or below a specific low threshold at the start of the study.
• People whose cancer has continued to grow after receiving at least one approved newer hormone-blocking drug, with or without prior chemotherapy, as long as no more than three lines of treatment have been received for castration-resistant prostate cancer (CRPC) — and people who carry certain gene mutations (BRCA1/2, PALB2, or HRD) but chose not to take an approved PARP inhibitor may also be considered.
• People whose cancer is confirmed to be progressing, shown by rising PSA levels on two separate tests at least one week apart, or by new or growing tumours on imaging scans, or by two or more new bone lesions on a bone scan.
• People who are able to undergo general anaesthesia, sedation, or a monitored form of anaesthesia.
• People with a general health and activity level rated at 0 or 1 on a standard scale used by doctors (meaning able to carry out daily activities, possibly with some limitations).
• People with a life expectancy of at least 6 months.
• People whose last cancer treatment (other than hormone therapy) was at least 28 days before the first study treatment; or at least 90 days before if that treatment was lutetium Lu 177 vipivotide tetraxetan (Pluvicto®).
• People who have recovered from any side effects of previous cancer treatments (hair loss excluded).
• Men with female partners who could become pregnant, who agree to use effective barrier contraception or true abstinence during treatment and for 120–150 days after the last dose (certain methods such as rhythm-based approaches, withdrawal, or spermicide-only are not accepted; using both a male and female condom together is also not accepted).
• People who have at least one measurable tumour lesion as assessed by standard imaging criteria (RECIST v1.1) at the start of the study.
• People who have at least one tumour lesion suitable for the study's treatment (SYNC-T Therapy), meeting specific size requirements — a soft tissue lesion at least 1 cm in two directions, a lymph node lesion of at least 1.5 cm (or 1.0 cm if detected on PET scan), or a measurable bone lesion with a soft tissue component — and that can be safely reached by needle through the skin or the area between the legs, and is not located next to major nerves, blood vessels, or the airway.
• People taking bone-strengthening medications who have been on a stable dose for at least 42 days before the study treatment begins.
• People for whom, in the treating doctor's judgement, no other meaningful life-prolonging treatment option is available, or who have declined other available treatments outside of hormone therapy.
• People with adequate bone marrow, kidney, and liver function as assessed by blood tests.
• People who agree to provide tumour tissue samples and undergo a tumour biopsy during treatment.

Who may not be able to join:

• People who have another active cancer (other than prostate cancer) that is growing or has required treatment in the last 3 years — with the exception of certain low-risk skin cancers, papillary thyroid cancer, or non-invasive breast duct cancer.
• People with a blocked urinary system, even after a stent has been placed.
• People who have had major surgery, including procedures on the prostate (other than prostate biopsy), within 28 days before the first study treatment, or who have not sufficiently recovered from such surgery.
• People who have taken blood thinners or anticoagulant medications within the timeframes set out in the study protocol.
• People with an active infection, including tuberculosis, that requires treatment with medicines taken throughout the body.
• People with a history of lung inflammation (not caused by infection) that has required steroid treatment.
• People who have received a live vaccine within 30 days before the planned start of study treatment.
• People currently in, or recently in, another clinical trial of an experimental drug or device within 28 days before the first study treatment.
• People with serious heart conditions such as severe heart failure, unstable chest pain, dangerous heart rhythm problems, or a history of heart failure.
• People with a specific heart electrical measurement (QTcF interval) above 470 milliseconds on a heart tracing (ECG) done during screening.
• People with cancer-related fluid build-up in the lungs or abdomen that requires urgent treatment.
• People with cancer that has spread to the brain, or who have a history of this.
• People with active autoimmune diseases such as lupus, scleroderma, myasthenia gravis, active Graves' disease, Goodpasture syndrome, Sjögren's syndrome, or Addison's disease — though people with a history of mild autoimmune conditions that have not needed ongoing immune-suppressing treatment and do not affect vital organs may still be considered.
• People with other immune system conditions that, in the doctor's judgement (in consultation with the medical team), could put them at risk or reduce treatment effectiveness.
• People with uncontrolled diabetes, relevant allergies, or other illnesses that the treating doctor considers would make participation unsafe.
• People who have had a bone marrow or stem cell transplant.
• People who have HIV infection or AIDS.
• People with an active COVID-19 infection, or who test positive for COVID-19 the day before or on the day of planned study treatment.
• People with an active viral hepatitis infection of any type.
• People with signs of a chronic hepatitis B infection with a very low viral load who are not on antiviral treatment — eligibility in this situation needs to be discussed with the study's medical team (confirm with trial site).
• People with a known or suspected hepatitis C infection that has not been successfully treated and cleared; people currently being treated for hepatitis C with an undetectable viral load, or who have completed curative treatment with a viral load below the detectable limit, may be eligible (confirm with trial site).
• People with certain liver complications, including blocked bile ducts within the liver, bleeding problems that cannot be corrected, or severe liver failure.
• People who have a BRCA gene mutation and agree to take an approved PARP inhibitor therapy.
• People with any other condition that, in the treating doctor's opinion, would increase the risk of harm from the study treatment or interfere with participation.
• People with cancer that has spread to internal organs, except for the lungs.
• People with known substance use issues, or medical, psychological, or social conditions that could interfere with participation.
• People who have received both chemotherapy and lutetium Lu 177 vipivotide tetraxetan (Pluvicto®) for castration-resistant prostate cancer.

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