Risk of Recurrent Disease 6 Years After Open or Robotic-assisted Radical Prostatectomy in the Prospective Controlled Trial LAPPRO.

"Financial disclosures: Anders Bjartell 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: None.

 Financial disclosures:"

"Financial disclosures: Anders Bjartell 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: None.

 Funding/Support and role of the sponsor: This study was supported by research grants from the 10.13039/501100002794Swedish Cancer Society (2008/922, 2010/593, 2013/497, 2016/362, 19 0303), the 10.13039/501100004359Swedish Research Council (2012-1770, 2015-02483), 10.13039/501100005754Region Västra Götaland, Sahlgrenska University Hospital (ALFBGB grants 13875, 146201, 4307771; HTA–VGR 6011; agreement concerning research and education of doctors), the Mrs. Mary von Sydow Foundation, and the Anna and Edvin Berger Foundation. Drs. Martin Nyberg and Anders Bjartell were supported by research grants from Region Skåne, Sweden, and Lund University. Sigrid V. Carlsson's work on this manuscript was supported in part by the 10.13039/100006156Sidney Kimmel Center for Prostate and Urologic Cancers and the 10.13039/100000002National Institutes of Health/National Cancer Institute (P50 CA926298, P30 CA00874, U01-CA199338-02 and K22 CA234400-01A1). None of the sponsors had any access to the data or any influence on or access to the analysis plan, the results, or the manuscript."

"The LAPPRO trial has been described in detail previously . In brief, LAPPRO is a prospective, controlled, nonrandomized trial comparing RALP and RRP. Enrollment took place between September 2008 and November 2011 at 14 Swedish departments of Urology, with seven performing RRP and seven RALP. Analyses included patients with the following criteria: age <75 yr, clinical tumor stage ≤T3, prostate-specific antigen (PSA) concentration at diagnosis <20 ng/ml, and no signs of distant metastasis. Clinical information was collected by health care personnel in case report forms (CRFs) before and during operation, as well as during hospital stay and 3, 12, and 24 mo after surgery. Patients answered four printed questionnaires before the operation and at 3, 12, and 24 mo postoperatively. Six years after radical prostatectomy, patients answered a structured telephone interview with 14 questions including PSA values, radiotherapy, and pharmacological treatments. Information on PSA, salvage or adjuvant treatment, disease progression, and metastatic spread was collected at follow-up and reported in CRFs (at 3, 12, and 24 mo) and at the telephone interview 6 yr after surgery. Telephone interviews were performed by a research nurse without access to individual patient data from the LAPPRO study. Date of death and cause of death were retrieved from the National Cause of Death Register (National Board of Health and Welfare) of Sweden. The study was approved by the Regional Ethical Review Board in Gothenburg (No 277-07) and registered in the Current Controlled Trials database (ISRCTN 06393679)."