Background: There is no high-grade evidence for surgery as primary treatment for locally advanced prostate cancer. The SPCG-15 study is the first randomized trial comparing surgical treatment with radiotherapy. Objective: To describe the baseline characteristics of the first 600 randomized men in the SPCG-15 study. The study will compare mortality and functional outcomes. Design, setting, and participants: This study is a Scandinavian prospective, open, multicenter phase III randomized clinical trial aiming to randomize 1200 men. Intervention: Radical prostatectomy with or without consecutive radiotherapy (experimental) and radiotherapy with neoadjuvant androgen deprivation therapy (standard of care). Outcome measurements and statistical analysis: Cause-specific survival, metastasis-free survival, overall survival, and patient-reported bowel function, sexual health, and lower urinary tract symptoms were measured. Results and limitations: The distribution of characteristics was similar in the two study arms. The median age was 67 yr (range 45–75 yr). Among the operated men, 36% had pT3a stage of disease and 39% had pT3b stage. International Society of Urological Pathology grades 2, 3, 4, and 5 were prevalent in 21%, 35%, 7%, and 27%, respectively. Half of the men (51%) in the surgery arm had no positive lymph nodes. The main limitation is the pragmatic design comparing the best available practice at each study site leading to heterogeneity of treatment regimens within the study arms. Conclusions: We have proved that randomization between surgery and radiotherapy for locally advanced prostate cancer is feasible. The characteristics of the study population demonstrate a high prevalence of advanced disease, well-balanced comparison groups, and a demography mirroring the Scandinavian population of men with prostate cancer at large. Patient summary: This study, which has recruited >600 men, compares radiotherapy with surgery for prostate cancer, and an analysis at the time of randomization indicates that the study will be informative and generalizable to most men with locally advanced but not metastasized prostate cancer.
Bibliografisk noteFunding Information:
Funding/Support and role of the sponsor: Study sponsor is Region Stockholm represented by Karolinska University Hospital. The study was financed by grants from the Swedish Research Council (dnr 2017-00546), the Nordic Cancer Union, and the Swedish state under the agreement between the Swedish government and the county councils (the ALF-agreement; grant number FoUI-953889). Individual author grants have been declared at submission. This work was supported in part by a grant from the Finnish Cancer Organisations (to Assistant Professor Rannikko) and Jane and Aatos Erkko Foundation.
Financial disclosures: Magdalena Gongora certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Magdalena Gongora has received a research scholarship connected to her position both as a PhD student and as a urology resident by Forskningsrådet KI-Region Stockholm (Research Council KI-Region Stockholm; grant number FoUI-955436). Antti Rannikko is a member of the board in Ida Montin Foundation and Orion Research Foundation; advisory board member for medical companies Bayer, Orion Pharma, and Janssen; and clinical advisor for Aqsens, company for which he has stock and investigator in clinical trials by Rho-Vac, Orion Pharma, Bayer, Astellas, Pfizer, and Janssen. Henrik Jakobsen has honoraria for education of colleagues sponsored by Bayer, Astellas, and MSD (2022). Fredrik Jäderling has financing from the Swedish state under the agreement between the Swedish government and the county councils (the ALF-agreement) 2021–2023, and holds presentation funded by AstraZeneca. Tuomas Mirtti has financing from Academy of Finland (grant no. 323098) and Cancer Foundation Finland (no specific grant number).