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 aged 18 or older at the time of signing the consent form.
• People who have a confirmed diagnosis of prostate cancer that has spread to other parts of the body (metastatic), is a specific cell type called adenocarcinoma, and does not have certain aggressive features (neuroendocrine or small cell).
• People whose prostate cancer has continued to grow despite having very low testosterone levels (through surgical removal of the testicles or ongoing hormone-lowering medication).
• People with a PSA level of 1 ng/mL or higher.
• People whose cancer has shown signs of getting worse within the 6 months before screening — either through imaging scans showing new or growing tumours in soft tissue or bones, or through a specific type of scan (PSMA PET) combined with rising PSA levels.
• People who have previously received certain hormone-blocking treatments (such as abiraterone, enzalutamide, apalutamide, or darolutamide) and a chemotherapy called a taxane. People who were not able to have taxane chemotherapy or chose not to may also be considered at the trial doctor's discretion.
• People with certain gene mutations (BRCA1 or BRCA2) who have also previously received a type of treatment called a PARP inhibitor, or who could not tolerate it. For people with other DNA repair gene defects (non-BRCA), the trial doctor will decide whether prior PARP inhibitor treatment is needed.
• People with a specific genetic feature of their cancer (high microsatellite instability or mismatch repair deficiency) who have also received at least one course of a checkpoint inhibitor treatment (such as pembrolizumab), or for whom that treatment is not suitable or was not tolerated.
• People who are generally well enough to carry out light activities and care for themselves (ECOG performance status 0 or 1) at the time of the cell collection procedure (apheresis).
• People expected to live for more than 12 weeks at the time of the cell collection procedure, in the trial doctor's judgement.
• People with adequately functioning organs and bone marrow (confirm specific values with trial site).
• People who agree to provide tumour tissue samples (fresh biopsies before and during treatment if medically possible, or an archived biopsy no older than 10 years if a fresh biopsy is not possible) for testing.

Who may not be able to join:

• People who weigh less than 39 kg.
• People who have had another type of cancer in the past, unless it was fully treated with no signs of return for at least 2 years and carries a low risk of coming back. Some exceptions apply, such as certain treated skin cancers or early-stage cancers with no remaining disease.
• People who have cancer that has spread to the brain.
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People with active or previously diagnosed autoimmune or inflammatory conditions — though some exceptions apply, including vitiligo, autoimmune hair loss, thyroid conditions that are stable on medication, mild skin conditions not needing systemic treatment, coeliac disease managed by diet alone, or conditions with no active disease in the last 5 years (the last group requires discussion with the trial sponsor).
• People who have had a stroke, bleeding in the brain, or seizure within 6 months before the cell collection procedure.
• People with certain heart rhythm problems that cause symptoms or require treatment, unless managed by a pacemaker (discussion with the trial doctor required); or people with uncontrolled irregular heart rhythm (atrial fibrillation), or a specific type of fast heart rhythm (sustained ventricular tachycardia) without symptoms.
• People with certain heart electrical readings (QT interval above 470 ms on an ECG), a history of heart rhythm problems caused by past medications, or a personal or close family history of a condition called long QT syndrome, or unexplained sudden death in a close family member under age 40.
• People with uncontrolled serious health conditions including active serious infections, certain heart muscle disease, significant heart failure, lung scarring disease, uncontrolled high blood pressure, uncontrolled diabetes, unstable chest pain, a heart attack within the past 6 months before the cell collection procedure, or known bleeding disorders such as haemophilia or von Willebrand disease.
• People with active or uncontrolled epilepsy. People without active or uncontrolled epilepsy for the last 5 years may be considered.
• People still experiencing side effects of grade 2 or higher from previous cancer treatments (except hair loss). Some exceptions may be considered on a case-by-case basis after discussion with the trial doctor.
• People who are HIV positive.
• People with active hepatitis C infection. People who test positive for hepatitis C antibodies may be considered if a further blood test shows no active virus.
• People with hepatitis B may be considered under certain conditions depending on specific test results and willingness to take antiviral medication during the study (confirm details with trial site).
• People who have recently received certain blood-thinning medications (full-dose long-acting anticoagulants such as warfarin, or clot-dissolving treatments) from the time of consent until 28 days after the study treatment is given. Shorter-acting blood thinners (such as rivaroxaban) are permitted for both treatment and prevention purposes.
• People who have had major surgery within 2 weeks before the cell collection procedure, or who have major surgery planned within 4 weeks of receiving the study treatment.
• People who have recently taken steroid medications (other than inhaled steroids) or certain immune-modifying drugs at therapeutic doses within 7 days before the cell collection procedure, or systemic steroids above a certain dose.
• People who received their last cancer treatment (chemotherapy, immunotherapy, targeted therapy, or similar) too recently before the cell collection procedure — the required gap depends on the treatment type (confirm specific timeframes with trial site). Radiotherapy within 14 days is generally not permitted, unless it covered a very small area of bone marrow.
• People currently receiving other cancer treatments, with some exceptions including the specific pre-treatment regimen defined in the trial, hormone therapy for non-cancer conditions, and testosterone-lowering treatment to keep hormone levels in the required range.
• People who have received a live vaccine within 30 days before the cell collection procedure. COVID-19 vaccines may be permitted at the trial doctor's discretion following a benefit/risk assessment.
• People who have previously received any CAR-T cell therapy, or any treatment specifically targeting a protein called STEAP2.
• People with a known serious allergy or intolerance to the study drug (AZD0754) or any of its ingredients, including a substance called dimethylsulfoxide.
• For people participating in Australia only: people who test positive for a virus called HTLV (human T-lymphotropic virus).

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