This trial is looking at using proton-based radiation therapy to target high-risk prostate tumors. The main outcome to be measured is the rate of recurrence 5 years after the end of the treatment. This study is taking place in Florida, USA.
The details
Prostate cancer can be treated by medication, surgery or radiation. Conventional radiation can have significant side effects. This is mainly due to irradiation of surrounding tissues. Proton therapy is a type of radiation therapy that limits the dose of radiation given to the surrounding healthy tissues.
This study aims to test is proton therapy is a good method of treatment for high-risk prostate cancer. The main outcome to be measured in this trial is the rate of relapse at 5 years after the end of therapy. Recurrence will be measured through the blood level of prostate-specific antigen (PSA; a protein in the prostate that rises in prostate cancer).
Who are they looking for?
88 participants are needed for this study. Participants should have an MRI to confirm the tumor 6 months before entering the study. Participants must not have anemia within 4 months before entering the study. Men of childbearing potential must be willing to use contraception during the treatment and 1 year after. Participants who are not sexually active or have had vasectomies do not have to use contraception. Participants must be able to start treatment within 16 weeks of registration.
Patients who are unable to undergo MRI of the prostate are also not allowed to participate. Patients who have had previous definitive treatment for prostate cancer including surgery, heat therapy, high-focus ultrasound therapy, radiation therapy, or cryotherapy (extreme cold therapy) will not be included in the study. Patients who have had a bilateral hip replacement or prior intrapelvic surgery (bladder surgery, rectal surgery, polyp removal or hemorrhoid removal or banding) will also not be included in the study. Patients with a history of heart attack, heart failure or end-stage kidney disease in the previous six months will not be included in the study. Patients must not have active inflammatory bowel disease which affects the rectum.
How will it work
All patients will begin taking androgen deprivation therapy (ADT; treatment that blocks male sex hormones involved in prostate cancer growth) 8-10 weeks before radiation therapy. This will be continued for a total of 18 months (including radiation therapy time).
Patients will be split into 3 groups according to the size and external extension of the tumor. All groups will receive proton radiation therapy in different doses and different localization, according to the tumor size and location. This treatment will be given once a day, 5 days a week (Monday to Friday), over 8-9 weeks. Patients will be followed up for relapse, survival and side effects up to 5 years.
