This phase I-II trial in the US aims to determine whether hypofractionated proton beam radiation therapy can achieve the same treatment benefits as current conventional radiation therapy in prostate cancer patients. The main outcome to be investigated is whether hypofractionated radiation can successfully maintain and control prostate cancer.
The details
Hypofractionated proton beam radiation therapy is a type of radiation therapy that involves receiving large, daily doses of radiation for a shorter period of time than standard radiaiton, in the aims of targeting the cancer cells while minimizing the damage done to normal cells.
This study will evaluate treatment effectiveness by looking at the side-effects experienced by patients and the effect of treatment on tumor control rates.
Who are they looking for?
This study will recruit 200 men over the age of 18 years that have confirmed adenocarcinoma within 180 days of registration, have undergone history and physical examination (including a digital rectal exam) 8 weeks prior to registration, have confirmed Gleason scores (scoring system that compares the differences between cancer cells and normal cells) and biopsies, have clinical stage T1-T2C (tumors identified through biopsy or can be felt by a doctor but is still confined to the prostate gland) and prostate specific antigen levels less than 10ng/ml within 180 days of registration.
Patients cannot take part in this trial if they have had or currently have malignant cancer or evidence of distant metastasis (cancer spread outside the prostate gland).
How will it work
Patients will receive proton radiation that will be administered once daily, 5 days per week for 20 treatments and any side-effects experienced will be recorded and compared to current radiation treatment.
