SPCG 19/ Get-Randomized- Prostate (Grand-P): A randomized, multi-center trial of immediate curative therapy compared with standard conservative treatment in older men aged ≥ 75 years with non-metastatic, high-risk prostate cancer
Immediate curative therapy (surgery/ radiatiotherapy) reduces the risk of progression and improves overall survival after 6-10 years in younger patients (<75 years) with non-metastatic, high risk prostate cancer. However, immediate curative therapy is essentially preventive and comes with the risk of overtreatment. Increasing life expectancy has raised the question if immediate curative therapy may also benefit the large patient group of older men (≥75yrs) that is usually treated conservatively and that has largely been excluded from previous randomized clinical trials. Many centers today opt to treat patients up to 80 yrs with immediate curative therapy. However, it is unclear if the survival benefit observed in younger patients can be achieved in older men. Despite increases in life expectancy, the life time of older men is limited. Furthermore, it is entirely unclear if immediate curative therapy helps to preserve long-term quality of life in older men or if it indeed causes more harm than benefit compared to a more conservative approach.
We therefore suggest a randomized, controlled, Scandinavian (SPCG) trial comparing immediate curative therapy of high-risk-non-metastatic prostate cancer to conservative, problem-directed management in patients 75 years or older (490 patients/ arm, total of 980 patients). We investigate if immediate curative treatment prolongs life and/ or improves health-related quality of life. The results of this study will have a major impact on national and international guidelines and demonstrate the feasibility of recruiting older patients to clinical trials.