This phase 3 trial will compare the safety and effectiveness of hypofractionated radiotherapy (HF-RT) to standard radiotherapy (RT).
The main outcomes will be the number of grade 2 side effects and disease control. This trial is recruiting in Houston, Texas, United States.
The details
Radiation therapy (RT) is a standard treatment for prostate cancer (PC). It can be very effective in killing cancer cells. It is also associated with some negative side effects. Standard RT uses a high energy beam to kill cancer cells. Hypofractionated radiation therapy (HF-RT) is a newer type of RT. It uses higher doses of energy over shorter periods of time. This may reduce the level of side effects.
This trial will compare the safety and effectiveness of HF-RT to standard RT. The main outcome will be the number of grade 2 side effects and disease control.
Who are they looking for?
This trial will recruit 176 patients with PC that has been surgically removed. Patients can receive androgen deprivation therapy (ADT) up to 24 months before the trial.
Patients cannot take part in the trial of they have had prior RT or chemotherapy. Patients cannot have medical conditions such as lupus, scleroderma, calcinosis, severe kidney or liver disease. Patients with unstable heart conditions e.g. angina, congestive heart failure are excluded from the trial.
How will it work
Patients will be randomly assigned to standard RT or HF-RT. This will be performed after PC surgery. RT will last 6.5 weeks. HF-RT will last 4.5 weeks. Patients will return for follow-up assessment after 3-6 months, and every 6-12 months thereafter (maximum 5 years).
The main outcomes will be the number of grade 2 side effects to the digestive or urinary system and tumor control.
