BACKGROUND: Treatment of localized prostate cancer (PC) is controversial. This is the first randomized study comparing an open surgery procedure (radical prostatectomy) with a combination of high-dose rate brachytherapy (2×10 Gy) and external beam radiotherapy (25×2 Gy) in PC patients in Sweden 1996-2001. The two randomization arms were compared regarding differences in patients-reported outcomes, such as complications and health-related quality of life (HRQoL). MATERIAL AND METHODS: The patients had localized/locally advanced PC, clinical category T1b-T3a, N0, M0 and PSA≤50 ng/ml. All underwent total androgen blockade (six months). Self-reported HRQoL and symptoms including urinary, bowel, and sexual side effects were investigated prospectively before randomization and 12 and 24 months after randomization. A total of 89 patients were randomized and completed the EORTC QLQ C-33 and EORTC PR-25 questionnaires. RESULTS: Over the study period, there were no discernible differences in HRQoL, or complications between the two groups. Emotional functioning, however, improved statistically significantly over time, whereas Social functioning decreased, and financial difficulties increased. No statistically significant differences in group-by-time interactions were found. The survival rate was 76%. Only eight patients (9%) died of PC. CONCLUSION:Open radical prostatectomy and the combined high-dose rate brachytherapy with external beam radiation appeared to be comparable in the measured outcomes. It was not possible to draw any conclusion on the efficacy of the two treatments due to insufficient power of the study.
RCT Entities:
BACKGROUND: Treatment of localized prostate cancer (PC) is controversial. This is the first randomized study comparing an open surgery procedure (radical prostatectomy) with a combination of high-dose rate brachytherapy (2×10 Gy) and external beam radiotherapy (25×2 Gy) in PC patients in Sweden 1996-2001. The two randomization arms were compared regarding differences in patients-reported outcomes, such as complications and health-related quality of life (HRQoL). MATERIAL AND METHODS: The patients had localized/locally advanced PC, clinical category T1b-T3a, N0, M0 and PSA≤50 ng/ml. All underwent total androgen blockade (six months). Self-reported HRQoL and symptoms including urinary, bowel, and sexual side effects were investigated prospectively before randomization and 12 and 24 months after randomization. A total of 89 patients were randomized and completed the EORTCQLQ C-33 and EORTC PR-25 questionnaires. RESULTS: Over the study period, there were no discernible differences in HRQoL, or complications between the two groups. Emotional functioning, however, improved statistically significantly over time, whereas Social functioning decreased, and financial difficulties increased. No statistically significant differences in group-by-time interactions were found. The survival rate was 76%. Only eight patients (9%) died of PC. CONCLUSION: Open radical prostatectomy and the combined high-dose rate brachytherapy with external beam radiation appeared to be comparable in the measured outcomes. It was not possible to draw any conclusion on the efficacy of the two treatments due to insufficient power of the study.
Authors: Brandon A Mahal; Santino Butler; Idalid Franco; Daniel E Spratt; Timothy R Rebbeck; Anthony V D'Amico; Paul L Nguyen Journal: JAMA Date: 2019-02-19 Impact factor: 56.272
Authors: Amar U Kishan; Ryan R Cook; Jay P Ciezki; Ashley E Ross; Mark M Pomerantz; Paul L Nguyen; Talha Shaikh; Phuoc T Tran; Kiri A Sandler; Richard G Stock; Gregory S Merrick; D Jeffrey Demanes; Daniel E Spratt; Eyad I Abu-Isa; Trude B Wedde; Wolfgang Lilleby; Daniel J Krauss; Grace K Shaw; Ridwan Alam; Chandana A Reddy; Andrew J Stephenson; Eric A Klein; Daniel Y Song; Jeffrey J Tosoian; John V Hegde; Sun Mi Yoo; Ryan Fiano; Anthony V D'Amico; Nicholas G Nickols; William J Aronson; Ahmad Sadeghi; Stephen Greco; Curtiland Deville; Todd McNutt; Theodore L DeWeese; Robert E Reiter; Johnathan W Said; Michael L Steinberg; Eric M Horwitz; Patrick A Kupelian; Christopher R King Journal: JAMA Date: 2018-03-06 Impact factor: 56.272
Authors: Ben G L Vanneste; Evert J Van Limbergen; Emile N van Lin; Joep G H van Roermund; Philippe Lambin Journal: Biomed Res Int Date: 2016-12-28 Impact factor: 3.411
Authors: Amar U Kishan; R Jeffrey Karnes; Tahmineh Romero; Jessica K Wong; Giovanni Motterle; Jeffrey J Tosoian; Bruce J Trock; Eric A Klein; Bradley J Stish; Robert T Dess; Daniel E Spratt; Avinash Pilar; Chandana Reddy; Rebecca Levin-Epstein; Trude B Wedde; Wolfgang A Lilleby; Ryan Fiano; Gregory S Merrick; Richard G Stock; D Jeffrey Demanes; Brian J Moran; Michelle Braccioforte; Hartwig Huland; Phuoc T Tran; Santiago Martin; Rafael Martínez-Monge; Daniel J Krauss; Eyad I Abu-Isa; Ridwan Alam; Zeyad Schwen; Albert J Chang; Thomas M Pisansky; Richard Choo; Daniel Y Song; Stephen Greco; Curtiland Deville; Todd McNutt; Theodore L DeWeese; Ashley E Ross; Jay P Ciezki; Paul C Boutros; Nicholas G Nickols; Prashant Bhat; David Shabsovich; Jesus E Juarez; Natalie Chong; Patrick A Kupelian; Anthony V D'Amico; Matthew B Rettig; Alejandro Berlin; Jonathan D Tward; Brian J Davis; Robert E Reiter; Michael L Steinberg; David Elashoff; Eric M Horwitz; Rahul D Tendulkar; Derya Tilki Journal: JAMA Netw Open Date: 2021-07-01