Phase 1 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:

• A diagnosis of prostate cancer that has been confirmed through tissue testing (biopsy).
• Willingness to have the prostate surgically removed (with or without removal of nearby lymph nodes), and a surgical team has determined this is a suitable option.
• High-risk prostate cancer, meaning at least one of the following applies: a Gleason score of 4+5 or higher (an aggressive cancer grade); lymph nodes in the pelvic area showing cancer on a PSMA PET scan; or cancer that has spread beyond the prostate capsule or into nearby seminal vesicles as seen on MRI.
• No signs of cancer that has spread to distant parts of the body on a PSMA PET scan — though cancer in nearby pelvic lymph nodes is still allowed.
• The main prostate tumour must show a specific level of radiotracer uptake (SUVmax greater than 10) on a PSMA PET scan using one of two approved tracers.
• The main tumour in the prostate must measure larger than 1.5 cm on MRI.
• Age 18 years or older.
• General health status that is reasonably functional, as rated by a standard medical scale (ECOG score of 2 or below).
• Blood, kidney, and liver test results that fall within acceptable ranges — including healthy enough levels of blood cell counts, kidney filtering function, liver enzymes, and protein levels (confirm specific numbers with trial site).
• Ability to understand and willingness to sign a formal consent document agreeing to participate.
• Willingness to follow recommended safety precautions related to radiation exposure during the study.
• Willingness to use adequate contraception and to not donate sperm while taking the study drug and for at least 14 weeks after the last treatment dose.

Who may not be able to join:

• People who have previously received any treatment for prostate cancer. (An exception applies for certain medications called 5-alpha reductase inhibitors — such as finasteride or dutasteride — if these were stopped at least 3 weeks before treatment begins.)
• People who have taken part in another clinical trial involving an experimental treatment or device within the past four weeks.
• People experiencing dry mouth severe enough to affect eating (for example, needing to use mouthwash before meals).
• People with serious ongoing medical conditions, such as severe heart failure, a history of a specific heart rhythm disorder present from birth (prolonged QT syndrome), uncontrolled infection, active hepatitis B or C, or other significant health conditions that the trial doctors determine would interfere with safe participation.
• People with another active cancer that is expected to affect life expectancy or interfere with assessing the prostate cancer — though people who had a previous cancer that was fully treated and have been free of that cancer and its treatment for more than 3 years may still be considered, as may people with certain treated skin cancers or superficial bladder cancers.
• People with a prior or current second cancer whose disease or treatment could affect the safety or results of this trial.
• People who have previously had external beam radiation therapy directed at the prostate or the area where the prostate was.

Additional criteria for a specific type of treatment delivery used in part of this trial (intraarterial administration):

• People with a severe allergy to iodinated contrast dye (the dye used in certain medical scans).
• People with severe hardening of the arteries seen on prior CT imaging, or a smoking history of more than 10 pack-years if no prior imaging is available (confirm details with trial site).

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