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:

• Men aged 18 or older at the time of giving consent
• People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer) confirmed by a laboratory tissue test
• People whose prostate cancer is classified as unfavorable intermediate or high-risk, is located in or near the prostate (not spread to distant parts of the body), and has a Gleason score of 7 (4+3) or higher — a scoring system doctors use to grade prostate cancer
• People whose cancer biopsy shows specific molecular features: a Decipher Genomic Classifier score above 0.45 and/or a "Luminal B" subtype, as shown on a Decipher report (confirm with trial site)
• People with a general health performance score of 0 or 1 on the ECOG scale — meaning fully active or able to carry out light activity (confirm with trial site)
• People who had hormonal therapy before, provided it was completed at least 12 months ago and all side effects have fully resolved
• People who have had major surgery, provided all complications and side effects have fully resolved before joining the study
• People whose blood, liver, and kidney test results fall within acceptable ranges as determined by the trial (confirm with trial site for specific values)
• People who agree to use a condom throughout the study and for 90 days after treatment ends, and to ensure an additional form of contraception is used by a female partner who could become pregnant
• People who are willing and able to read and sign a consent form
• People who have a current hepatitis B infection, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before joining
• People with a history of hepatitis C infection, provided they have completed curative antiviral treatment at least 4 weeks before joining and the virus is undetectable at screening
• People with a known HIV infection, provided the viral load is undetectable (minor fluctuations up to 200 copies/mL are acceptable), and they have been on stable HIV treatment for at least 12 weeks

Who may not be able to join:

• People whose prostate cancer has spread to distant parts of the body (metastatic disease)
• People with a Gleason score of 7 (3+4) or lower
• People with a Decipher biopsy score of 0.45 or below
• People who have had hormonal therapy for prostate cancer, unless they meet the exceptions described in the inclusion criteria above
• People who have previously had radiation therapy or chemotherapy for prostate cancer
• People who have had a serious heart event in the 6 months before starting treatment, such as a heart attack, severe chest pain, heart failure, or a hospital admission for any heart-related reason
• People with an active stomach or bowel condition that could interfere with how the body absorbs the study drug
• People who have previously been treated with certain hormone-blocking medications used for prostate cancer, such as apalutamide, darolutamide, enzalutamide, or abiraterone acetate
• People who are unable to swallow tablets or capsules
• People who have an active infection requiring antibiotic or antiviral treatment within 7 days before starting the study
• People who have previously received certain types of cancer immunotherapy treatments, including anti-PD1, anti-PDL1, anti-PDL2, or other immune checkpoint or T-cell therapies
• People with active hepatitis B or hepatitis C infection with detectable virus, a known HIV infection with a detectable viral load, or chronic liver disease requiring ongoing treatment
• People with active tuberculosis (TB) or a current or past history of a lung inflammation condition called non-infectious pneumonitis
• People with a weakened immune system, or those taking immune-suppressing medications (such as steroid tablets above a certain dose) within 7 days before starting the study — though inhaled or topical steroids may be permitted in some cases (confirm with trial site)
• People who have had an active autoimmune disease requiring systemic treatment in the past 2 years — though people on simple hormone replacement therapies (such as insulin or thyroid medication) may still be eligible
• People with a condition or personal history that could interfere with the study results or their ability to participate safely, including certain psychiatric conditions, epilepsy, or substance use disorders
• People with known cancer spread to the brain
• People with a known history of serious allergic reactions to medications similar in composition to those used in this trial

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