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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
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- Gongora, M. (author)
- Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden,Karolinska Inst, Dept Mol Med & Surg, GKS D1 05, S-17176 Stockholm, Sweden.;Karolinska Univ Hosp, Dept Pelv Canc, Stockholm, Sweden
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- Stranne, Johan, 1970 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för urologi,Institute of Clinical Sciences, Department of Urology,Department of Urology, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden; Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden,Sahlgrens Univ Hosp, Dept Urol, Reg Vastra Gotaland, Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Inst Clin Sci, Dept Urol, Gothenburg, Sweden
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- Johansson, Eva (author)
- Uppsala universitet,Urologkirurgi
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- Bottai, M. (author)
- Karolinska Institutet
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- Thellenberg-Karlsson, Camilla, 1972- (author)
- Umeå universitet,Onkologi,Umeå Univ, Dept Radiat Sci, Oncol, Umeå, Sweden
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- Brasso, K. (author)
- Department of Urology, Center for Cancer and Organ Diseases, Copenhagen Prostate Cancer Center, Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark,Copenhagen Univ Hosp, Ctr Canc & Organ Dis, Copenhagen Prostate Canc Ctr, Dept Urol,Rigshosp, Copenhagen, Denmark.;Univ Copenhagen, Dept Clin Med, Copenhagen, Denmark
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- Hansen, S. (author)
- Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Oncology, Odense University Hospital, Odense, Denmark,Univ Southern Denmark, Dept Clin Res, Odense, Denmark.;Odense Univ Hosp, Dept Oncol, Odense, Denmark
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- Jakobsen, H. (author)
- Department of Urology, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark,Univ Copenhagen, Herlev Hosp, Dept Urol, Copenhagen, Denmark
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- Jaderling, F. (author)
- Karolinska Institutet
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- Lindberg, H. (author)
- Department of Oncology, Copenhagen University Hospital − Herlev and Gentofte, Herlev, Denmark,Copenhagen Univ Hosp Herlev & Gentofte, Dept Oncol, Herlev, Denmark
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- Lilleby, W. (author)
- Radiumhospital, Oslo University Hospital, Oslo, Norway,Oslo Univ Hosp, Radiumhosp, Oslo, Norway
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- Petersen, P. M. (author)
- Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark,Copenhagen Univ Hosp, Rigshosp, Dept Oncol, Copenhagen, Denmark
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- Mirtti, T. (author)
- Department of Pathology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland; iCAN-Digital Precision Cancer Medicine Flagship, Helsinki, Finland,Univ Helsinki, Dept Pathol, Helsinki, Finland.;Helsinki Univ Hosp, Helsinki, Finland.;Univ Helsinki, Fac Med, Res Program Syst Oncol, Helsinki, Finland.;iCAN Digital Precis Canc Med Flagship, Helsinki, Finland
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- Olsson, M. (author)
- Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden,Karolinska Univ Hosp, Dept Pelv Canc, Stockholm, Sweden.;Karolinska Inst, Dept Clin Sci Intervent & Technol, Stockholm, Sweden
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- Rannikko, A. (author)
- Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland; Department of Urology, Faculty of Medicine and Helsinki University Hospital, University of Helsinki, Helsinki, Finland,Univ Helsinki, Fac Med, Res Program Syst Oncol, Helsinki, Finland.;Univ Helsinki, Fac Med, Dept Urol, Helsinki, Finland.;Univ Helsinki, Helsinki Univ Hosp, Helsinki, Finland
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- Roder, M. A. (author)
- Department of Urology, Center for Cancer and Organ Diseases, Copenhagen Prostate Cancer Center, Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark,Copenhagen Univ Hosp, Ctr Canc & Organ Dis, Copenhagen Prostate Canc Ctr, Dept Urol,Rigshosp, Copenhagen, Denmark.;Univ Copenhagen, Dept Clin Med, Copenhagen, Denmark
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- Vincent, P. H. (author)
- Karolinska Institutet
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- Akre, O. (author)
- Karolinska Institutet
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Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden Karolinska Inst, Dept Mol Med & Surg, GKS D1 05, S-17176 Stockholm, Sweden;Karolinska Univ Hosp, Dept Pelv Canc, Stockholm, Sweden (creator_code:org_t)
- Elsevier BV, 2022
- 2022
- English.
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In: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 41, s. 63-73
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Abstract
Subject headings
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- 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. (C) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Prostatic neoplasms
- Locally advanced prostate cancer
- Radical
- prostatectomy
- Radiotherapy
- Androgen deprivation
- Curative treatment
- Quality of life
- Randomized
- nationwide
- survival
- Urology & Nephrology
- Androgen deprivation
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Gongora, M.
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Stranne, Johan, ...
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Johansson, Eva
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Bottai, M.
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Thellenberg-Karl ...
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Brasso, K.
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Hansen, S.
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Jakobsen, H.
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Jaderling, F.
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Lindberg, H.
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Lilleby, W.
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Petersen, P. M.
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Mirtti, T.
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Olsson, M.
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Rannikko, A.
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Roder, M. A.
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Vincent, P. H.
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Akre, O.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Urology and Neph ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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European Urology ...
- By the university
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University of Gothenburg
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Umeå University
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Uppsala University
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Karolinska Institutet