Phase 1 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 cancer that has spread to other parts of the body and is no longer responding to hormone-lowering treatments (confirmed by a tissue or cell sample).
• People who have visible signs of cancer spread on standard scans such as CT, MRI, or bone scan — this can include spread to bones, lymph nodes, or organs.
• People who are currently receiving hormone-suppressing treatment (such as injections or tablets to lower testosterone), or who have had surgical removal of the testicles.
• People whose testosterone blood level is at or below 50 ng/dL (a very low level), which must be maintained throughout the trial.
• People whose cancer has continued to grow despite hormone-suppressing treatment, shown by at least two rising PSA blood test results (at least one week apart, with the last result being 2 ng/mL or higher), or by worsening scans.
• People who have already received at least one of the newer hormone-blocking medicines (such as enzalutamide, abiraterone, apalutamide, or darolutamide) and whose cancer progressed on that treatment.
• People who have had radiation therapy are welcome, provided bone radiation finished at least 14 days before joining, and any other radiation finished at least 28 days before joining.
• People whose side effects from previous treatments have mostly resolved or are mild and stable.
• People aged 18 or older.
• People who are generally well enough to carry out normal daily activities with little or no limitation (as assessed by a standard medical scale called ECOG, score of 0 or 1).
• People whose blood counts and organ function (bone marrow, liver, kidneys, and blood clotting) meet specific healthy thresholds as measured by blood tests.
• People with a normal heart electrical reading (QTcF interval of 500 ms or less on an ECG).
• People who are willing and able to understand and sign a consent form.
• People willing to have a tumour tissue sample (biopsy) taken for research purposes, if placed in the part of the trial focused on finding the right dose.
• Men who are sexually active with female partners must agree to use two forms of contraception (including one barrier method such as a condom) during the trial and for five months after the last dose of study treatment, and must notify the trial team if their partner becomes pregnant during that time.

Who may not be able to join:

• People who have taken a type of targeted cancer medicine called a small molecule kinase inhibitor within the 14 days before the first dose of study treatment.
• People whose prostate cancer is entirely a rare type called small cell variant, or any type that does not contain the standard form (adenocarcinoma).
• People who are unable to swallow pills.
• People who need to take high-dose steroid medicines (more than 10 mg of prednisone per day or equivalent) or other medicines that suppress the immune system within 14 days before starting the study (low-dose or inhaled/topical steroids may be allowed in certain cases — confirm with trial site).
• People who currently have another active cancer, or who were diagnosed with another cancer within the past three years that still requires treatment (some minor skin cancers that have been fully treated may be acceptable — confirm with trial site).
• People who are currently taking part in another trial that involves receiving an experimental treatment.
• People who have taken certain hormone-blocking prostate cancer medicines (such as anti-androgen agents or abiraterone) within 14 days — or a longer period depending on the specific medicine — before starting the study drug.
• People who have received a radioactive treatment called Radium-223 or similar radioactive medicines within 28 days before starting the study drug.
• People who have digestive system problems that could affect how medicines are absorbed (such as having had parts of the stomach or bowel removed) — as determined by the treating doctor.
• People who have had a blood transfusion within 28 days before the screening assessment.
• People who have used hormonal medicines or supplements that could act against prostate cancer within 28 days before starting the study drug, as determined by the treating doctor.
• People who would need to start a new bone-strengthening medicine (such as zoledronic acid or denosumab) after joining the trial (those already on these medicines before joining may continue them).
• People with cancer that has spread to the brain or surrounding brain tissue, unless it has been successfully treated and has been stable for at least four weeks, and the person has no neurological symptoms.
• People with a history of seizures or a seizure disorder.
• People who have had a serious allergic reaction to medicines chemically similar to the study drug (R)-9bMS.
• People with serious uncontrolled ongoing health conditions, including:
  • Severe heart failure, unstable chest pain, or serious irregular heart rhythms.
  • High blood pressure that cannot be controlled with medication (above 160/90 mmHg).
  • A stroke, heart attack, or serious blood clot (such as a deep vein thrombosis or pulmonary embolism) within the past six months (some minor or well-treated clot cases may be considered — confirm with trial site).
  • Certain serious digestive system conditions such as active stomach ulcers, inflammatory bowel disease, or bowel perforation, particularly within the last six months.
  • Significant bleeding (such as coughing or vomiting blood) within the past 12 weeks.
  • Certain lung conditions including cavities in the lungs or disease affecting the airways.
  • Cancer tumours that are growing into or wrapping around major blood vessels.
  • Serious non-healing wounds, fractures, or ulcers.
  • Uncontrolled thyroid problems (underactive thyroid with symptoms).
  • Moderate to severe liver disease.
• People with active hepatitis B, hepatitis C, or active HIV (people with well-controlled HIV or hepatitis, or who have been cured of hepatitis C, may be considered after discussion with the trial doctor).
• People who have previously received an organ transplant.
• People who have had major surgery within eight weeks before the first dose (wound healing must also be fully complete — confirm timing with trial site).
• People whose overall health, in the opinion of the treating doctor, could be put at risk by joining the trial, or whose condition could make the study results difficult to interpret.
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the trial requirements.
• People who are currently receiving active treatment in another Phase I, II, or III clinical trial (being followed up long-term in a previous trial is acceptable).

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