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:

Phase I (early safety phase):

• People who are willing and able to give informed consent and agree to follow all study procedures and attend all required visits
• Men aged 40 years or older
• People with a history of prostate cancer diagnosis, including those who have been treated (through surgery, radiation, or anti-hormone therapy), those with low-risk localised prostate cancer who chose not to have treatment, those with favourable intermediate-risk localised prostate cancer who declined treatment, and those with high-risk or unfavourable intermediate-risk localised prostate cancer who declined surgery, radiation, or hormone therapy
• People who are not currently receiving radiation therapy or hormone-blocking therapy (ADT) at the time of enrolment
• People with a general health status rated as reasonably functional (ECOG score of 0–2, meaning able to carry out at least some daily activities) (confirm with trial site)
• People with normal liver function, kidney function, and blood cell counts at the start of the trial, based on standard blood tests
• People, and their partners, who agree to use two medically accepted forms of contraception during the trial and for at least one week after the last dose of the study drug — accepted methods include abstinence, barrier methods with spermicide, certain intrauterine devices (IUDs), or hormonal contraceptives combined with a barrier method
• People taking certain medications that affect how the body processes drugs (strong CYP3A4 or CYP2C19 inhibitors or inducers) may still be considered, with the treating doctor's assessment of any potential interactions
• People currently taking herbal supplements containing AGN extract (such as Cogni.Q, Decursinol-50, Ache Action, or Fast-Acting Joint Formula) who are able to stop these at least 4 weeks before starting the study drug

Phase II (main study phase):

• People who are willing and able to give informed consent and agree to follow all study procedures and attend all required visits
• Men aged 40 years or older
• People with a confirmed diagnosis of prostate adenocarcinoma (a specific type of prostate cancer), of any stage or grade, excluding neuroendocrine or small cell prostate cancer types
• People who meet one of the following situations: have had surgery or radiation for prostate cancer (including those with local return of cancer who have declined further treatment), or have localised prostate cancer and declined treatment after a discussion with their doctor
• People who have not had cancer spread to distant parts of the body, confirmed by imaging scans (such as CT, MRI, bone scan, or specialised PET scan) within the past 5 years
• People whose PSA blood test results have been rising across two separate tests at least one week apart within the past 6 months, with readings of 0.1 ng/mL or above
• People who are not currently receiving hormone-blocking therapy (ADT), and whose testosterone level is above a specified level if they have previously received such therapy (confirm with trial site)
• People with a general health status rated as reasonably functional (ECOG score of 0–2) (confirm with trial site)
• People with normal liver, kidney, and blood cell function based on standard blood tests at the start of the trial
• People with no other active cancer that currently requires treatment
• People, and their partners, who agree to use two medically accepted forms of contraception during the trial and for at least one week after the last study drug dose, using the same accepted methods listed above for Phase I
• People taking certain medications that affect drug processing (strong CYP3A4 or CYP2C19 inhibitors or inducers) may still be considered, at the treating doctor's discretion
• People currently taking herbal supplements containing AGN extract (such as those listed above) who are able to stop these at least 4 weeks before starting the study drug
• People who took part in Phase I of this trial may be eligible for Phase II if at least 90 days have passed since their last dose, they did not experience serious (Grade 3 or higher) side effects related to the treatment, any treatment-related side effects have largely resolved, and their liver and kidney function are within acceptable limits and their doctor confirms they are clinically stable

Who may not be able to join:

• People whose prostate cancer has spread to distant parts of the body (distant metastases) — note that people with cancer in nearby lymph nodes who have completed treatment may still be considered
• People currently receiving systemic treatments such as chemotherapy, hormone-blocking therapies (including LHRH agonists, antagonists, GnRH analogs, or antiandrogens), immunotherapy (checkpoint inhibitors), or other investigational treatments
• People with serious uncontrolled health conditions at the treating doctor's judgement, which may include active infections, severe heart failure symptoms, unstable chest pain, heart rhythm problems, poorly controlled diabetes (HbA1c above 9), uncontrolled asthma, or significant psychiatric illness that would affect the ability to participate
• People with a history of severe heart failure (classified as New York Heart Association Class III or IV), a heart attack within the past 6 months, or other heart-related problems that the treating doctor considers a reason not to participate
• People with another active cancer that requires treatment
• People with severely reduced kidney function below a specified level based on calculated or measured kidney filtration rate (confirm with trial site)
• People currently taking the blood-thinning medication warfarin (also known as coumadin)
• People who have had both testicles surgically removed (bilateral orchiectomy) are not eligible for Phase II

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