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 are willing and able to sign a consent form and take part in all study activities for the full duration of the trial

• People aged 18 or older at the time of signing the consent form

• People whose doctor estimates they are expected to live for at least 3 months

• People who are relatively active and able to care for themselves, with little or no limitation in daily activities (this is measured using a standard medical scale called ECOG Performance Status 0–1)

• People whose blood counts, kidney function, and liver function meet certain minimum levels, as measured by blood tests taken within 10 days of joining the study (confirm specific values with trial site)

• People willing to follow lifestyle guidelines set out by the study for its duration

• People with a confirmed diagnosis of one of the following two cancer types:

  Prostate Cancer:

• People with a confirmed diagnosis of prostate adenocarcinoma (a specific type of prostate cancer confirmed by tissue or cell testing)

• People whose prostate cancer has spread to other parts of the body (metastatic), is no longer responding to hormone-lowering treatments (castration-resistant), and is getting worse at the time of screening

• People with testosterone (a hormone) levels below 50 ng/dL during screening

• People whose prostate cancer has stopped responding to at least one prior hormone-blocking treatment (such as abiraterone, enzalutamide, apalutamide, or darolutamide)

• People who have at least one area of cancer spread visible on a scan (CT, MRI, or bone scan) taken within 28 days before joining the trial

  Breast Cancer:

• People with a confirmed diagnosis of invasive breast cancer that has spread to other parts of the body (metastatic), which has been previously treated

• People whose metastatic breast cancer can be measured using a standard method called RECIST 1.1

• People whose breast cancer has stopped responding to at least two prior hormone-based or targeted treatments, or at least two rounds of chemotherapy; or, for HER2-positive breast cancer, people whose cancer has stopped responding to — or who could not tolerate — at least one HER2-targeted treatment

• People who have at least one area of cancer spread visible on a scan (CT, MRI, or bone scan) taken within 28 days before joining the trial

Who may not be able to join:

• People who are pregnant (a negative pregnancy test within 7 days before joining is required) or currently breastfeeding

• People who have had a heart attack within the past year, or people who had a heart attack more than one year ago and currently need to use nitroglycerin (a heart medication) more than once a week

• People with serious heart problems, including uncontrolled chest pain, severe irregular heart rhythms, significant disease around the heart, a heart attack within the past year, or a diagnosis of moderate-to-severe heart failure (Class 3 or higher on a standard heart function scale)

• People with a diagnosis of a weakened immune system, or who have been taking steroid medications or other immune-suppressing drugs within 7 days before joining (note: hormone replacement therapies for conditions like thyroid or adrenal insufficiency are generally not considered immune-suppressing in this context — confirm with trial site)

• People with a wound, ulcer, or bone fracture that has not healed, or who have had major surgery, an open biopsy, or a significant injury within 28 days before joining

• People with active liver disease such as cirrhosis or chronic hepatitis

• People who are HIV positive, or who have an active Hepatitis B or Hepatitis C infection

• People who have active bleeding, or a condition associated with a high risk of bleeding (note: being on blood-thinning medication for treatment purposes is generally permitted — confirm with trial site)

• People who have an active infection currently being treated with systemic (whole-body) medication

• People with a serious uncontrolled medical condition that the investigating doctor believes could be made worse by the trial treatment

• People with a known history of active tuberculosis (TB)

• People who have received a live vaccine within 30 days before joining the trial

• People who have taken part in another clinical trial using an experimental treatment within 3 weeks before joining

• People who have another active cancer currently requiring systemic treatment (exceptions may include certain skin cancers or previously treated cervical cancer — confirm with trial site)

• People who have an active autoimmune disease (where the immune system attacks the body) that has required systemic medical treatment within the 2 years before joining (note: hormone replacement therapies are generally not considered systemic treatment in this context — confirm with trial site)

• People with any other medical condition, past treatment, or abnormal test result that, in the treating doctor's opinion, could affect the trial results or make participation unsafe

• People who, in the opinion of the trial team, may not be able to reliably follow the study requirements

  Additional exclusions for people with Prostate Cancer:

• People whose prostate cancer has been identified as a specific rare type called small cell neuroendocrine carcinoma (either alone or mixed with other types)

• People who have a BRCA1 or BRCA2 gene change for which approved treatments (such as PARP inhibitors) are available and considered appropriate — unless those treatments are not suitable as determined by the treating doctor, or the person declines them (people with these gene changes who have already tried and stopped responding to targeted therapy may still be eligible)

  Additional exclusions for people with Breast Cancer:

• People who have a BRCA1 or BRCA2 gene change for which approved treatments (such as PARP inhibitors) are available and considered appropriate — unless those treatments are not suitable as determined by the treating doctor, or the person declines them (people with these gene changes who have already tried and stopped responding to targeted therapy may still be eligible)

• People whose breast cancer is causing an immediate, life-threatening crisis, including large uncontrolled fluid build-ups around the lungs, heart, or abdomen, cancer spread throughout the lung's lymph vessels, or cancer affecting more than 50% of the liver

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