Study Comparing Immediate Curative Treatment Versus Conservative Care in Men 75 and Older With High-risk, Non-metastatic Prostate Cancer

What this Trial Is About

Researchers are investigating the best treatment approach for older men aged 75 years and above with high-risk, non-metastatic prostate cancer. This trial aims to determine whether immediate curative treatments like radiotherapy or surgery provide the same survival and quality of life benefits as seen in younger patients, or if the risks and side effects might outweigh these benefits. The study also evaluates if early side effects from immediate treatment are balanced by better long-term cancer control and quality of life. Participants are randomly assigned to one of two groups. One group receives immediate curative therapy, which includes radiotherapy combined with hormone therapy or, for some, surgery called radical prostatectomy. The other group receives conservative treatment involving observation or hormone therapy, with further treatment as needed based on disease progression. This open-label, multicenter study compares these two approaches over a long-term period. During the study, participants will undergo regular assessments including quality of life questionnaires and evaluations of urinary, bowel, and prostate cancer-related symptoms. The primary outcomes measured are overall survival and disease burden over up to 10 years. Secondary outcomes include role functioning, symptom-free survival, metastasis-free survival, and the need for additional treatments. The study monitors participants health status and quality of life throughout this extended follow-up period.

Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer