Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 signed an informed consent form before any study procedures begin.
• People who agree to have tissue samples collected at specific points during the study.
• People who agree to a specific laboratory research protocol used at MD Anderson (PA13-0291).
• Men aged 18 years or older.
• People who have been diagnosed with prostate cancer confirmed through laboratory testing of tissue or cell samples.
• People whose cancer has spread to other parts of the body, as shown on imaging scans such as bone scans, CT scans, or MRI.
• People whose cancer meets at least one of a specific set of features known as "aggressive variant prostate cancer" (AVPC) criteria — these include things like a particular cancer cell type (small cell/neuroendocrine), cancer that has spread mainly to organs, certain patterns of bone spread, large tumours or lymph nodes, a very low PSA with many bone metastases, certain abnormal blood markers, rapid progression after hormone treatment, specific gene changes in TP53, RB1, or PTEN, or disease progression seen on scans without rising PSA levels (confirm with trial site for which criteria apply).
• People whose cancer is showing clear signs of getting worse, shown by rising PSA levels, new or growing areas of disease on scans, new bone lesions, worsening symptoms clearly linked to cancer growth as judged by the treating doctor, or a new biopsy showing a change in cancer type.
• People whose testosterone levels have been reduced to very low levels (≤50 ng/dL) through surgery or ongoing medication — with a specific exception allowed for people newly diagnosed with small cell prostate cancer who have recently started hormone-blocking treatment even if testosterone has not yet reached that level.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG Performance Status).
• People whose blood counts and organ function (including blood cell levels, liver function, and kidney function) meet minimum thresholds when tested within 7 days before joining the study (confirm specific values with trial site).
• People with a partner who could become pregnant must be willing to use contraception during the study and for 3 months after the last dose of study treatment, and must not donate sperm during this time.
• People who are willing and able to follow the study schedule, including attending appointments and completing follow-up visits.

Who may not be able to join:

• People who have previously been treated for castration-resistant prostate cancer with carboplatin, cisplatin, or cabazitaxel.
• People who have received more than one course of chemotherapy for prostate cancer (any number of hormone or targeted therapies are permitted).
• People who have not sufficiently recovered from side effects of previous cancer treatments, surgery, or radiation, where those side effects are still rated above a mild level.
• People who still have unresolved side effects from previous cancer treatment rated as moderate or worse — although people with permanent but stable side effects (such as hearing loss or nerve-related symptoms) that are unlikely to be made worse by the study treatment may still be considered.
• People with an active infection that is not under control (cases where infection is considered controlled after completing antibiotics or antiviral treatment may be discussed with the lead investigator).
• People with active or symptomatic viral hepatitis or ongoing chronic liver disease.
• People with a history of significant disease affecting both lungs that is not related to cancer.
• People who have had another type of cancer (other than the prostate cancer being treated in this study) that has a 30% or greater chance of coming back within 24 months — although certain previously treated skin cancers, cervical cancers, or early-stage bladder cancers may be exceptions (confirm with trial site).
• People with certain serious medical or psychiatric conditions that the investigator believes would make the study treatment unsafe or make it hard to assess side effects — examples include uncontrolled heart rhythm problems, a heart attack within the past 3 months, certain lung conditions, uncontrolled seizures, a history of organ transplant, or a primary immune deficiency.
• People with brain metastases or spinal cord compression that is causing symptoms and is not under control.
• People who are in prison or held in custody against their will.
• People who are being held involuntarily for treatment of a psychiatric or physical illness.
• People who have had a serious allergic reaction to the study drug (ADI-PEG 20), similar types of drugs, or other agents used in this study.

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