This phase 2 trial will investigate the safety and effectiveness of stereotactic body radiation therapy (SBRT) in patients with localized prostate cancer (PC) who had surgical removal of the prostate.
The main outcomes will be survival without recurrence and side effects. This study is recruiting in Los Angeles, California, the US.
Radiation therapy (RT) is commonly used to treat prostate cancer (PC). RT usually involves large doses of radiation. It is also applied to the pelvic area around the prostate. Both cancer and healthy tissue are exposed to radiation using standard RT. Stereotactic body radiation therapy (SBRT) is a type of RT that involves using lower doses of radiation over several days. It is more specific than standard RT. It used multiple beams that focus on the tumor area only. SBRT may cause less damage to healthy tissue.
This trial will investigate the safety and effectiveness of SBRT in localized PC that has been surgically removed. The main outcomes will be survival without recurrence and side effects.
Who are they looking for?
This trial will recruit 60 patients with localized adenocarcinoma of the prostate that has been completely removed by surgery. Participants must have elevated prostate-specific antigen (PSA; a blood marker of prostate cancer). Patients must undergo a bone scan to confirm the absence of metastases (spread tumors).
Patients with metastases in the lymph nodes or other organs cannot take part in the trial. Patients previously treated with radiotherapy, cryosurgery or high-intensity focused ultrasound (HIFU) are also excluded from the trial. A history of Crohn’s disease and ulcerative colitis (inflammatory bowel conditions) are also exclusion criteria.
How will it work
All patients recruited to the trial will undergo SBRT once a day. SBRT will last 14 days. Participants may also be treated with anti-androgen (hormonal therapy) medication for 6 months. Follow-up will be performed up to 5 years after treatment.
The main outcomes will be survival and side effects.