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SPCG-15: a prospective randomized study comparing primary radical prostatectomy and primary radiotherapy plus androgen deprivation therapy for locally advanced prostate cancer
Univ Gothenburg, Dept Urol, Inst Clin Sci, Sahlgrenska Acad, Gothenburg, Sweden.
Rigshosp Copenhagen, Copenhagen Prostate Canc Ctr, Copenhagen, Denmark; Rigshosp Copenhagen, Dept Urol, Copenhagen, Denmark.
Oslo Univ Hosp HF, Dept Urooncol, Radiumhosp, Oslo, Norway.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Urology.ORCID iD: 0000-0002-4039-0547
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2018 (English)In: Scandinavian journal of urology, ISSN 2168-1805, E-ISSN 2168-1813, Vol. 52, no 5-6, p. 313-320Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2018. Vol. 52, no 5-6, p. 313-320
Keywords [en]
Locally advanced prostate cancer, radical prostatectomy, radiotherapy, androgen deprivation therapy
National Category
Urology and Nephrology
Identifiers
URN: urn:nbn:se:uu:diva-381395DOI: 10.1080/21681805.2018.1520295ISI: 000461876400001PubMedID: 30585526OAI: oai:DiVA.org:uu-381395DiVA, id: diva2:1303302
Funder
Swedish Research Council, 2017-00546Available from: 2019-04-09 Created: 2019-04-09 Last updated: 2019-10-16Bibliographically approved

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