Gonzales

Researchers are evaluating two radiation therapy approaches for men with high-risk prostate cancer in this phase III trial. The study compares stereotactic body radiation therapy (SBRT), which delivers five higher-dose treatments over two weeks, to the usual radiation therapy that involves 20 to 45 treatments over 4 to 9 weeks. This trial aims to see if the shorter SBRT treatment can prevent cancer from returning as effectively as the longer conventional treatment while monitoring survival without metastasis. Participants are randomly assigned to one of two groups. One group receives SBRT with five treatments over two weeks, while the other undergoes external beam radiation therapy (EBRT) with 20 to 45 treatments over 4 to 9 weeks. Both groups have imaging scans such as bone scans, CT, MRI, or PET/CT during screening and study follow-up. Blood and urine samples may be collected optionally. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants have regular follow-ups every six months for five years. Researchers assess outcomes including metastasis-free survival, toxicity reported by physicians, patient-reported urinary and bowel function, fatigue, failure-free survival, overall survival, sexual function, quality of life, and treatment burden. Various questionnaires and imaging tests support these evaluations, helping to monitor safety and effectiveness over time.

Researchers are evaluating treatments for patients with non-muscle invasive bladder cancer, including those with recurrent disease or stage I bladder cancer. This phase II trial compares the addition of pembrolizumab, an immunotherapy drug that may help the immune system attack cancer cells, combined with radiation therapy, to the usual chemotherapy treatments combined with radiation. Chemotherapy drugs used include cisplatin, gemcitabine, 5-fluorouracil, or mitomycin-C, which work to stop tumor growth in various ways. Radiation therapy uses high-energy rays or particles to kill cancer cells and shrink tumors, and combining it with pembrolizumab may improve treatment effects. Participants are randomly assigned to one of two treatment groups. One group receives chemotherapy chosen by their doctor (cisplatin intravenously once weekly for 4 weeks; or gemcitabine intravenously on specified days; or mitomycin intravenously on day 1 plus continuous 5-fluorouracil infusion over days 1-5 and 16-20) alongside radiation therapy delivered over 4 to 7 weeks for 20, 32, or 36 treatments. The other group receives pembrolizumab intravenously every 6 weeks for up to 9 cycles along with the same radiation therapy schedule. Treatment continues unless the disease progresses or side effects become unacceptable. Throughout the study, participants undergo CT or MRI scans and blood sample collections, with optional urine samples. After treatment, follow-up visits occur every 3 months for 2 years, every 6 months for 3 years, then annually up to 5 years. Researchers assess bladder-intact event-free survival and overall quality of life, along with response by cystoscopy, disease progression, survival rates, side effects, and patient-reported measures including fatigue and quality-adjusted survival.