Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer

James, Nicholas D.; Spears, Melissa; Clarke, Noel W.; Dearnaley, David P.; Mason, Malcolm David; Parker, Christopher; Ritchie, A. W. S.; Russell, John M.; Schiavone, Francesca; Attard, Gerhardt; Bono, Johann S. de; Birtle, Alison; Engeler, Daniel S.; Elliott, Tony; Matheson, David; O’Sullivan, Joe M.; Pudney, Delia; Srihari, Narayanan; Wallace, Jan; Barber, Jim; Syndikus, Isabel; Parmar, Mahesh; Sydes, Matthew R.

doi:10.1001/jamaoncol.2015.4350

Cited by 176 publications

(128 citation statements)

References 23 publications

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“…This is the sixth comparison in the trial for which we are reporting survival data 15,16,[24][25][26][27] and the first comparison incorporated after trial initiation. 22 The use of ADT plus abiraterone and prednisolone as compared with ADT alone was associated with a 71% relative improvement in the time to treatment failure, which translated into a 37% difference in overall survival.…”

Section: Discussionmentioning

confidence: 99%

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

et al. 2017

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BACKGROUND\ud Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design.\ud METHODS\ud We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer).\ud RESULTS\ud A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease. Grade 3 to 5 adverse events occurred in 47% of the patients in the combination group (with nine grade 5 events) and in 33% of the patients in the ADT-alone group (with three grade 5 events).\ud CONCLUSIONS\ud Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than ADT alone. (Funded by Cancer Research U.K. and others; STAMPEDE ClinicalTrials.gov number, NCT00268476, and Current Controlled Trials number, ISRCTN78818544.

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Section: Discussionmentioning

confidence: 99%

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

et al. 2017

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“…In men with cN1 or pN1 the outcome of radiotherapy alone is poor, and these patients should receive RT plus long-term ADT, as shown by the STAMPEDE trial where the use of radiotherapy improved failure-free survival in men with N+ PCa [75].…”

Section: Lymph Node Irradiationmentioning

confidence: 99%

EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent

et al. 2017

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“…However, the question of pelvic radiotherapy is gaining renewed interest in high risk node negative prostate cancer especially as there is now increasing supportive data for the use ADT with prostate and pelvic radiotherapy in the management of node positive disease [1] [2] [3].…”

Section: Introductionmentioning

confidence: 99%

The Re-Emerging Role of Elective Pelvic Nodal Irradiation in High-Risk Node Negative Prostate Cancer

Mangar¹

2017

JCT

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The benefit of elective nodal irradiation (ENI) in combination with androgen deprivation therapy in high risk localized node negative prostate cancer has yet to be clearly defined. The potential gains in local control have been offset by the increased toxicity associated with pelvic radiotherapy, and recognition that historically the only trials to demonstrate a survival advantage in this group have been with androgen deprivation therapy. This review article considers the impact of pivotal randomized clinical trials conducted over the last thirty years on routine clinical practice, and how modern techniques may help to redefine radiotherapy as a necessary component for this group of patients.

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Failure-Free Survival and Radiotherapy in Patients With Newly Diagnosed Nonmetastatic Prostate Cancer

Abstract: clinicaltrials.gov Identifier: NCT00268476; ISRCTN78818544.

Cited by 176 publications

References 23 publications

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent

The Re-Emerging Role of Elective Pelvic Nodal Irradiation in High-Risk Node Negative Prostate Cancer

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