This study aims to test the effectiveness of focal ablation (laser therapy used to remove and kill cancer cells) of large prostate cancer sites using ultrasound and biopsy (tissue samples taken from the cancer site) one year after treatment. The main outcome to be measured will be the removal of cancer cells confirmed by a negative biopsy test, with little damage done to healthy cells around it. This trial is currently recruiting in New York and Texas.
The details
Focal ablation can destroy large tumor cells found in the prostate gland. This works by injecting specific particles through IV (into the vein) and then using ultrasound to destroy cells by laser irridation.
The current trial aims to determine the benefit of focal ablation against prostate cancer. The main outcome to be measured is the number of remaining cancer cells by biopsy following treatment.
Who are they looking for?
This trial will recruit 45 men with low to intermediate risk cancer (confined to the prostate gland) that has been diagnosed by a biopsy.
Men with additional illnesses besides prostate cancer or who are receiving additional investigational treatments will not be included. Men must not have more than 3 confirmed positive cancer lesions or metastatic cancer (cancer spread outside of the prostate gland). Men with other medical or surgical conditions will not be eligible for recruitment. Men must not have urinary infections, be unable to undergo MRI scans (imaging technique) or have an increased risk of bleeding.
How will it work
Participants will receive one single IV infusion of AuroShell particles 12-36 hours before an ultrasound-guided laser procedure to destroy cancer cells.
The main outcome is to determine the efficacy of focal ablation against prostate cancer.