J Stranne1, K Brasso2, B Brennhovd3, E Johansson4, F Jäderling5, M Kouri6, W Lilleby3, P Meidahl Petersen7, T Mirtti8, A Pettersson9, A Rannikko10, C Thellenberg11, O Akre12. 1. a Department of Urology , Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden. 2. b Copenhagen Prostate Cancer Center and Department of Urology, Rigshospitalet Copenhagen , Copenhagen , Denmark. 3. c Department of Uro-Oncology, Radiumhospitalet , Oslo University Hospital HF , Oslo , Norway. 4. d Department Of Urology , Uppsala University Hospital , Uppsala , Sweden. 5. e Department of Radiology , Karolinska Institutet/University Hospital , Stockholm , Sweden. 6. f Department of Oncology , Helsinki University Hospital , Helsinki , Finland. 7. g Department of Oncology , The Finsen Centre, Copenhagen University Hospital , Copenhagen , Denmark. 8. h Institute for Molecular Medicine Finland (FIMM), University of Helsinki , Helsinki , Finland. 9. i Department of Medicine Solna , Karolinska Institutet , Clinical Epidemiology Unit , Stockholm , Sweden. 10. j Department of Urology , Helsinki University Hospital , Helsinki , Finland. 11. k Cancercentrum , Norrlands University Hospital , Umeå , Sweden. 12. l Department of Molecular Medicine and Surgery , Karolinska Institutet , Stockholm , Sweden.
Abstract
OBJECTIVE: To describe study design and procedures for a prospective randomized trial investigating whether radical prostatectomy (RP) ± radiation improves cause-specific survival in comparison with primary radiation treatment (RT) and androgen deprivation treatment (ADT) in patients with locally advanced prostate cancer (LAPC). MATERIALS AND METHODS:SPCG-15 is a prospective, multi-centre, open randomized phase III trial. Patients are randomized to either standard (RT + ADT) or experimental (RP with extended pelvic lymph-node dissection and with addition of adjuvant or salvage RTand/or ADT if deemed necessary) treatment. Each centre follows guidelines regarding the timing and dosing of postoperative RT and adjuvant treatment such as ADT The primary endpoint is cause-specific survival. Secondary endpoints include metastasis-free and overall survival, quality-of-life, functional outcomes and health-services requirements. Each subject will be followed up for a minimum of 10 years. RESULTS:Twenty-three centres in Denmark, Finland, Norway and Sweden, well established in performing RP and RT for prostate cancer participated. Each country's sites were coordinated by national coordinating investigators and sub-investigators for urology and oncology. Almost 400 men have been randomized of the stipulated 1200, with an increasing rate of accrual. CONCLUSIONS: The SPCG-15 trial aims to compare the two curatively intended techniques supplying new knowledge to support future decisions in treatment strategies for patients with LAPC The Scandinavian healthcare context is well suited for performing multi-centre long-term prospective randomized clinical trials. Similar care protocols and a history of entirely tax-funded healthcare facilitate joint trials.
RCT Entities:
OBJECTIVE: To describe study design and procedures for a prospective randomized trial investigating whether radical prostatectomy (RP) ± radiation improves cause-specific survival in comparison with primary radiation treatment (RT) and androgen deprivation treatment (ADT) in patients with locally advanced prostate cancer (LAPC). MATERIALS AND METHODS: SPCG-15 is a prospective, multi-centre, open randomized phase III trial. Patients are randomized to either standard (RT + ADT) or experimental (RP with extended pelvic lymph-node dissection and with addition of adjuvant or salvage RT and/or ADT if deemed necessary) treatment. Each centre follows guidelines regarding the timing and dosing of postoperative RT and adjuvant treatment such as ADT The primary endpoint is cause-specific survival. Secondary endpoints include metastasis-free and overall survival, quality-of-life, functional outcomes and health-services requirements. Each subject will be followed up for a minimum of 10 years. RESULTS: Twenty-three centres in Denmark, Finland, Norway and Sweden, well established in performing RP and RT for prostate cancer participated. Each country's sites were coordinated by national coordinating investigators and sub-investigators for urology and oncology. Almost 400 men have been randomized of the stipulated 1200, with an increasing rate of accrual. CONCLUSIONS: The SPCG-15 trial aims to compare the two curatively intended techniques supplying new knowledge to support future decisions in treatment strategies for patients with LAPC The Scandinavian healthcare context is well suited for performing multi-centre long-term prospective randomized clinical trials. Similar care protocols and a history of entirely tax-funded healthcare facilitate joint trials.
Authors: R Bischoff; M Chaloupka; T Westhofen; T Grimm; B Schlenker; P Weinhold; D Tilki; C G Stief; A Kretschmer Journal: Urologe A Date: 2019-05 Impact factor: 0.639
Authors: Benedikt Hoeh; Jan L Hohenhorst; Rocco Flammia; Benedikt Horlemann; Gabriele Sorce; Francesco Chierigo; Zhe Tian; Fred Saad; Markus Graefen; Michele Gallucci; Alberto Briganti; Carlo Terrone; Shahrokh F Shariat; Luis A Kluth; Andreas Becker; Felix K H Chun; Pierre I Karakiewicz Journal: Int Urol Nephrol Date: 2021-11-16 Impact factor: 2.370