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 have been diagnosed with localised intermediate-risk or high-risk prostate cancer, confirmed through a tissue or cell sample test (intermediate-risk means a Gleason score of 7 and PSA under 10; high-risk means a Gleason score of 8–10, PSA over 10, or cancer that has grown just outside the prostate capsule)
• People whose treatment plan includes a type of targeted radiation called SBRT to the prostate, along with hormone therapy (ADT)
• People who have prostate tissue available from a biopsy taken within the past year for biomarker testing — if the existing sample is not suitable, a new biopsy before starting treatment will be required
• People who are male and aged 18 or older
• People who are generally well enough to carry out daily activities (confirm with trial site regarding the specific fitness level required)
• People whose blood counts, liver function, kidney function, and other organ measures meet specific minimum levels set by the trial (confirm with trial site for exact values)
• People with a testosterone level above 100 ng/dL
• People who agree to use reliable contraception during the study and for 6 months after completing radiation or immunotherapy (whichever ends last)
• People whose prostate cancer can be accessed for a biopsy
• People who are willing and able to understand and sign a written consent form

Who may not be able to join:

• People whose cancer has spread to distant parts of the body, including lymph nodes outside the pelvis or other areas beyond the pelvis
• People who have previously had surgery to remove the prostate, focal therapy, or radiation to the prostate (note: prior use of certain hormone-related medications such as finasteride, dutasteride, or bicalutamide may be permitted at the doctor's discretion)
• People who have already started hormone therapy (ADT), SBRT, or pelvic radiation before enrolling in the trial
• People who have received a live vaccine within 30 days before starting treatment (non-live flu vaccines and locally approved COVID-19 vaccines are permitted)
• People who cannot have an mpMRI scan, for example due to an allergy to contrast dye that cannot be managed with pre-treatment medication
• People for whom SBRT radiation would not be safe, such as those with rectal involvement, a history of inflammatory bowel disease, or prior radiation in the same area that has already reached tissue tolerance limits
• People with other serious health conditions that would make hormone therapy (ADT) unsafe, or uncontrolled ongoing illnesses or circumstances considered too high-risk by the treating doctor
• People with active immune system deficiencies, ongoing inflammatory conditions, active autoimmune diseases, or people taking long-term medications that suppress the immune system, where this could affect the trial's immune response measurements
• People who require regular systemic steroid medications above a certain dose (above the equivalent of 10 mg of prednisone daily), except for inhaled steroids or low-dose replacement steroids, and only in the absence of active autoimmune disease (confirm with trial site for specific details)
• People living with HIV
• People with an active Hepatitis B or Hepatitis C infection
• People with significant ongoing or recent serious infections, including tuberculosis with clinical signs or findings
• People who have had an allergic reaction to compounds similar in makeup to the study drug PDS01ADC
• People who have had another cancer that was active within the past 3 years, except for certain cancers considered effectively treated, such as some skin cancers, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low-risk Gleason 6 prostate cancer

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