Characteristics of Patients in SPCG-15-A Randomized Trial Comparing Radical Prostatectomy with Primary Radiotherapy plus Androgen Deprivation Therapy in Men with Locally Advanced Prostate Cancer

Magdalena Gongora; Johan Stranne; Eva Johansson; Matteo Bottai; Camilla Thellenberg Karlsson; Klaus Brasso; Steinbjørn Hansen; Henrik Jakobsen; Fredrik Jäderling; Henriette Lindberg; Wolfgang Lilleby; Peter Meidahl Petersen; Tuomas Mirtti; Mats Olsson; Antti Rannikko; Martin Andreas Røder; Per Henrik Vincent; Olof Akre

doi:10.1016/j.euros.2022.04.013

Characteristics of Patients in SPCG-15-A Randomized Trial Comparing Radical Prostatectomy with Primary Radiotherapy plus Androgen Deprivation Therapy in Men with Locally Advanced Prostate Cancer

Eur Urol Open Sci. 2022 May 26:41:63-73. doi: 10.1016/j.euros.2022.04.013. eCollection 2022 Jul.

Authors

Magdalena Gongora^{1

2}, Johan Stranne^{3

4}, Eva Johansson⁵, Matteo Bottai⁶, Camilla Thellenberg Karlsson⁷, Klaus Brasso^{8

9}, Steinbjørn Hansen^{10

11}, Henrik Jakobsen¹², Fredrik Jäderling^{1

13}, Henriette Lindberg¹⁴, Wolfgang Lilleby¹⁵, Peter Meidahl Petersen¹⁶, Tuomas Mirtti^{17

18

19}, Mats Olsson^{2

20}, Antti Rannikko^{18

21}, Martin Andreas Røder^{8

9}, Per Henrik Vincent^{1

2}, Olof Akre^{1

2}

Affiliations

¹ Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
² Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.
³ Department of Urology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.
⁴ Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
⁵ Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
⁶ Division of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
⁷ Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.
⁸ Department of Urology, Center for Cancer and Organ Diseases, Copenhagen Prostate Cancer Center, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
⁹ Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
¹⁰ Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
¹¹ Department of Oncology, Odense University Hospital, Odense, Denmark.
¹² Department of Urology, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.
¹³ Department of Radiology, Capio S:t Görans Hospital, Stockholm, Sweden.
¹⁴ Department of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
¹⁵ Radiumhospital, Oslo University Hospital, Oslo, Norway.
¹⁶ Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark.
¹⁷ Department of Pathology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
¹⁸ Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.
¹⁹ iCAN-Digital Precision Cancer Medicine Flagship, Helsinki, Finland.
²⁰ Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
²¹ Department of Urology, Faculty of Medicine and Helsinki University Hospital, University of Helsinki, Helsinki, Finland.

Abstract

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.

Keywords: Androgen deprivation; Curative treatment; Locally advanced prostate cancer; Prostatic neoplasms; Quality of life; Radical prostatectomy; Radiotherapy; Randomized.