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 diagnosed with localized high-risk or very high-risk prostate cancer, based on a standard cancer classification system (NCCN v4.2023).
• People whose prostate biopsy results show cancer in 3 or more biopsy samples, with cancer covering at least half of each of those samples.
• People whose PSA blood test result is above 4 ng/mL, tested within 28 days before joining the trial.
• People who have had a specialised scan (PSMA-PET/CT) within 28 days before joining, showing no cancer spread to distant parts of the body.
• People who are a suitable candidate for prostate removal surgery (radical prostatectomy), with that surgery scheduled to happen 3 to 14 days after joining the trial.
• People who have not received, and do not plan to receive, any pre-surgery treatments such as radiation therapy, hormone therapy (ADT), or any other cancer treatment.
• People with a life expectancy of more than 5 years.

After surgery, additional criteria apply for people to continue in the randomised part of the trial:

• People whose surgical findings show the cancer has grown beyond the prostate (stage greater than pT3a), or who have a specific cancer spread pattern (pT3b or pT4) with a Gleason score of 7 (4+3).
• People whose removed prostate tissue has a Gleason score of 8, 9, or 10 (indicating high or very high-grade cancer).
• People who have had pelvic lymph node removal (PLND) as part of their surgery, with results showing either no cancer in the lymph nodes (pN0) or some cancer in the lymph nodes (pN1).
• People whose surgical margins are either clear of cancer or show only very small, microscopic traces of cancer at the edges.

At two months after surgery, final criteria apply before randomisation:

• People for whom the trial's personalised treatment (FK-PC101) has been successfully produced and meets all required quality standards.
• People whose PSA blood test result is undetectable (below 0.04 ng/mL), tested 4 to 7 days before randomisation.
• People who have not had, are not currently having, and do not plan to have any post-surgery cancer treatments such as radiation therapy, hormone therapy, or other cancer treatments — unless cancer comes back (for example, through a rising PSA).
• People whose blood test and organ function results, taken within two weeks before Day 1, meet specific minimum levels, including adequate white blood cell counts, platelet counts, red blood cell levels, kidney function, liver enzyme levels, and protein levels (confirm specific values with the trial site).

Who may not be able to join:

• People who have another active cancer that could interfere with assessing the trial's results (though some skin cancers and certain non-invasive cancers may still be eligible — confirm with the trial site).
• People who are eligible for, and choose to receive, additional cancer treatment (adjuvant therapy) after their prostate removal surgery.
• People with serious heart conditions, such as severe heart failure, uncontrolled angina, a history of heart attack, stroke, blood clot in the lungs, or uncontrolled high blood pressure or irregular heartbeat within the past 6 months.
• People with serious, uncontrolled lung disease — such as severe chronic obstructive pulmonary disease or high blood pressure in the lungs — that the trial doctor believes would create significant risks during the study.
• People with known cancer spread (metastases) to bones, organs, the brain, or the lining of the brain or spinal cord.
• People with an active autoimmune disease, or severe lung inflammation (grade 3 or higher), that has required systemic medical treatment in the past 2 years (note: routine hormone replacement therapies are generally not considered systemic autoimmune treatment — confirm with trial site).
• People currently taking steroid medication at a dose equivalent to more than 10 mg of prednisone daily for at least one week, or any other immune-suppressing medication taken within 7 days before joining.
• People with serious uncontrolled health conditions, including uncontrolled infections, a serious blood-clotting disorder, or mental health or personal circumstances that would make it difficult to follow the study requirements.
• People who are at risk of a widespread BCG infection, or who have had an allergic reaction to BCG or its components in the past.
• People with a known diagnosis of HIV, or active or chronic Hepatitis B or Hepatitis C.
• People whom the trial doctor considers to be at unacceptably high risk of serious side effects from the trial treatment.

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