MRI-Guided LEAD Stereotactic Radiotherapy with or without Ultra-Short Term Androgen Deprivation Therapy for the Treatment of Prostate Cancer, the Miami UAdapt Trial
This phase II trial tests how well magnetic resonance imaging (MRI)-guided lattice extreme ablative dose (LEAD) stereotactic body radiotherapy (SBRT) with or without ultra-short term androgen deprivation therapy (uSTADT) works in treating patients with prostate cancer. Stereotactic body radiotherapy (SBRT) is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). This type of radiation therapy helps spare normal tissue. Focal therapy LEAD (FTLEAD) RT, a single dose of SBRT, uses multiparametric-MRI (mpMRI) imaging to identify the areas of tumor in order to deliver radiation to only the areas of tumor within the prostate. Androgen deprivation therapy (ADT) is treatment to suppress or block the production or action of male hormones, and uSTADT is treatment over 1 month. Relugolix, a type of ADT, lowers the amount of testosterone made by the body, or blocks the use of testosterone by the tumor cells. This may help stop the growth of tumor cells that need testosterone to grow. Giving FTLEAD RT with or without uSTADT may be effective in treating the tumor within the prostate and decrease the impact on quality of life in prostate cancer patients. This trial also evaluates the effectiveness of FTLEAD RT followed by hypofractionated LEAD (HypoLEAD) RT to the entire prostate in higher risk patients. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving FTLEAD RT followed by HypoLEAD RT to the entire prostate may improve disease control while reducing side effects and maintaining quality of life in higher-risk prostate cancer patients.