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Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial

Summary Background Prostate cancer is a major public health problem with considerable uncertainties about the effectiveness of population screening and treatment options. We report the study design, participant sociodemographic and clinical characteristics, and the initial results of the testing and... Full description

Journal Title: The Lancet Oncology 2014, Vol.15 (10), p.1109-1118
Main Author: Lane, J Athene, PhD
Other Authors: Donovan, Jenny L, Prof , Davis, Michael, MSc , Walsh, Eleanor, MSc , Dedman, Daniel, MSc , Down, Liz, BSc , Turner, Emma L, PhD , Mason, Malcolm D, Prof , Metcalfe, Chris, PhD , Peters, Tim J, Prof , Martin, Richard M, PhD , Neal, David E, Prof , Hamdy, Freddie C, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Men
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
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title: Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial
format: Article
creator:
  • Lane, J Athene, PhD
  • Donovan, Jenny L, Prof
  • Davis, Michael, MSc
  • Walsh, Eleanor, MSc
  • Dedman, Daniel, MSc
  • Down, Liz, BSc
  • Turner, Emma L, PhD
  • Mason, Malcolm D, Prof
  • Metcalfe, Chris, PhD
  • Peters, Tim J, Prof
  • Martin, Richard M, PhD
  • Neal, David E, Prof
  • Hamdy, Freddie C, Prof
subjects:
  • Aged
  • Biopsy
  • Biopsy, Needle
  • Cancer
  • Clinical trials
  • Disease-Free Survival
  • Follow-Up Studies
  • Hematology, Oncology and Palliative Medicine
  • Humans
  • Immunohistochemistry
  • Intervention
  • Laboratories
  • Male
  • Medicin och hälsovetenskap
  • Men
  • Metastasis
  • Middle Aged
  • Mortality
  • Neoplasm Grading
  • Neoplasm Recurrence, Local - mortality
  • Neoplasm Recurrence, Local - pathology
  • Oncology
  • Oncology, Experimental
  • Patient Selection
  • Patients
  • Prostate cancer
  • Prostate-Specific Antigen - blood
  • Prostatectomy - methods
  • Prostatectomy - mortality
  • Prostatic Neoplasms - mortality
  • Prostatic Neoplasms - pathology
  • Prostatic Neoplasms - therapy
  • Radiation therapy
  • Radiotherapy
  • Radiotherapy, Conformal - methods
  • Radiotherapy, Conformal - mortality
  • Risk Assessment
  • Surgery
  • Survival Analysis
  • Treatment Outcome
  • Ultrasonic imaging
  • United Kingdom
  • Watchful Waiting - methods
ispartof: The Lancet Oncology, 2014, Vol.15 (10), p.1109-1118
description: Summary Background Prostate cancer is a major public health problem with considerable uncertainties about the effectiveness of population screening and treatment options. We report the study design, participant sociodemographic and clinical characteristics, and the initial results of the testing and diagnostic phase of the Prostate testing for cancer and Treatment (ProtecT) trial, which aims to investigate the effectiveness of treatments for localised prostate cancer. Methods In this randomised phase 3 trial, men aged 50–69 years registered at 337 primary care centres in nine UK cities were invited to attend a specialist nurse appointment for a serum prostate-specific antigen (PSA) test. Prostate biopsies were offered to men with a PSA concentration of 3·0 μg/L or higher. Consenting participants with clinically localised prostate cancer were randomly assigned to active monitoring (surveillance strategy), radical prostatectomy, or three-dimensional conformal external-beam radiotherapy by a computer-generated allocation system. Randomisation was stratified by site (minimised for differences in participant age, PSA results, and Gleason score). The primary endpoint is prostate cancer mortality at a median 10-year follow-up, ascertained by an independent committee, which will be analysed by intention to treat in 2016. This trial is registered with ClinicalTrials.gov , number NCT02044172 , and as an International Standard Randomised Controlled Trial, number ISRCTN20141297. Findings Between Oct 1, 2001, and Jan 20, 2009, 228 966 men were invited to attend an appointment with a specialist nurse. Of the invited men, 100 444 (44%) attended their initial appointment and 82 429 (82%) of attenders had a PSA test. PSA concentration was below the biopsy threshold in 73 538 (89%) men. Of the 8566 men with a PSA concentration of 3·0–19·9 μg/L, 7414 (87%) underwent biopsies. 2896 men were diagnosed with prostate cancer (4% of tested men and 39% of those who had a biopsy), of whom 2417 (83%) had clinically localised disease (mostly T1c, Gleason score 6). With the addition of 247 pilot study participants recruited between 1999 and 2001, 2664 men were eligible for the treatment trial and 1643 (62%) agreed to be randomly assigned (545 to active monitoring, 545 to radiotherapy, and 553 to radical prostatectomy). Clinical and sociodemographic characteristics of randomly assigned participants were balanced across treatment groups. Interpretation The ProtecT trial randomly assigned
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
  • 1474-5488
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titleActive monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial
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creatorLane, J Athene, PhD ; Donovan, Jenny L, Prof ; Davis, Michael, MSc ; Walsh, Eleanor, MSc ; Dedman, Daniel, MSc ; Down, Liz, BSc ; Turner, Emma L, PhD ; Mason, Malcolm D, Prof ; Metcalfe, Chris, PhD ; Peters, Tim J, Prof ; Martin, Richard M, PhD ; Neal, David E, Prof ; Hamdy, Freddie C, Prof
creatorcontribLane, J Athene, PhD ; Donovan, Jenny L, Prof ; Davis, Michael, MSc ; Walsh, Eleanor, MSc ; Dedman, Daniel, MSc ; Down, Liz, BSc ; Turner, Emma L, PhD ; Mason, Malcolm D, Prof ; Metcalfe, Chris, PhD ; Peters, Tim J, Prof ; Martin, Richard M, PhD ; Neal, David E, Prof ; Hamdy, Freddie C, Prof ; for the ProtecT study group ; ProtecT study group
descriptionSummary Background Prostate cancer is a major public health problem with considerable uncertainties about the effectiveness of population screening and treatment options. We report the study design, participant sociodemographic and clinical characteristics, and the initial results of the testing and diagnostic phase of the Prostate testing for cancer and Treatment (ProtecT) trial, which aims to investigate the effectiveness of treatments for localised prostate cancer. Methods In this randomised phase 3 trial, men aged 50–69 years registered at 337 primary care centres in nine UK cities were invited to attend a specialist nurse appointment for a serum prostate-specific antigen (PSA) test. Prostate biopsies were offered to men with a PSA concentration of 3·0 μg/L or higher. Consenting participants with clinically localised prostate cancer were randomly assigned to active monitoring (surveillance strategy), radical prostatectomy, or three-dimensional conformal external-beam radiotherapy by a computer-generated allocation system. Randomisation was stratified by site (minimised for differences in participant age, PSA results, and Gleason score). The primary endpoint is prostate cancer mortality at a median 10-year follow-up, ascertained by an independent committee, which will be analysed by intention to treat in 2016. This trial is registered with ClinicalTrials.gov , number NCT02044172 , and as an International Standard Randomised Controlled Trial, number ISRCTN20141297. Findings Between Oct 1, 2001, and Jan 20, 2009, 228 966 men were invited to attend an appointment with a specialist nurse. Of the invited men, 100 444 (44%) attended their initial appointment and 82 429 (82%) of attenders had a PSA test. PSA concentration was below the biopsy threshold in 73 538 (89%) men. Of the 8566 men with a PSA concentration of 3·0–19·9 μg/L, 7414 (87%) underwent biopsies. 2896 men were diagnosed with prostate cancer (4% of tested men and 39% of those who had a biopsy), of whom 2417 (83%) had clinically localised disease (mostly T1c, Gleason score 6). With the addition of 247 pilot study participants recruited between 1999 and 2001, 2664 men were eligible for the treatment trial and 1643 (62%) agreed to be randomly assigned (545 to active monitoring, 545 to radiotherapy, and 553 to radical prostatectomy). Clinical and sociodemographic characteristics of randomly assigned participants were balanced across treatment groups. Interpretation The ProtecT trial randomly assigned 1643 men with localised prostate cancer to active monitoring, radiotherapy, or surgery. Participant clinicopathological features are more consistent with contemporary patient characteristics than in previous prostate cancer treatment trials. Funding UK National Institute for Health Research Health Technology Assessment Programme.
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subjectAged ; Biopsy ; Biopsy, Needle ; Cancer ; Clinical trials ; Disease-Free Survival ; Follow-Up Studies ; Hematology, Oncology and Palliative Medicine ; Humans ; Immunohistochemistry ; Intervention ; Laboratories ; Male ; Medicin och hälsovetenskap ; Men ; Metastasis ; Middle Aged ; Mortality ; Neoplasm Grading ; Neoplasm Recurrence, Local - mortality ; Neoplasm Recurrence, Local - pathology ; Oncology ; Oncology, Experimental ; Patient Selection ; Patients ; Prostate cancer ; Prostate-Specific Antigen - blood ; Prostatectomy - methods ; Prostatectomy - mortality ; Prostatic Neoplasms - mortality ; Prostatic Neoplasms - pathology ; Prostatic Neoplasms - therapy ; Radiation therapy ; Radiotherapy ; Radiotherapy, Conformal - methods ; Radiotherapy, Conformal - mortality ; Risk Assessment ; Surgery ; Survival Analysis ; Treatment Outcome ; Ultrasonic imaging ; United Kingdom ; Watchful Waiting - methods
ispartofThe Lancet Oncology, 2014, Vol.15 (10), p.1109-1118
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0Lane et al. Open Access article distributed under the terms of CC BY
12014 Lane et al. Open Access article distributed under the terms of CC BY
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1Donovan, Jenny L, Prof
2Davis, Michael, MSc
3Walsh, Eleanor, MSc
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5Down, Liz, BSc
6Turner, Emma L, PhD
7Mason, Malcolm D, Prof
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9Peters, Tim J, Prof
10Martin, Richard M, PhD
11Neal, David E, Prof
12Hamdy, Freddie C, Prof
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0Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial
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descriptionSummary Background Prostate cancer is a major public health problem with considerable uncertainties about the effectiveness of population screening and treatment options. We report the study design, participant sociodemographic and clinical characteristics, and the initial results of the testing and diagnostic phase of the Prostate testing for cancer and Treatment (ProtecT) trial, which aims to investigate the effectiveness of treatments for localised prostate cancer. Methods In this randomised phase 3 trial, men aged 50–69 years registered at 337 primary care centres in nine UK cities were invited to attend a specialist nurse appointment for a serum prostate-specific antigen (PSA) test. Prostate biopsies were offered to men with a PSA concentration of 3·0 μg/L or higher. Consenting participants with clinically localised prostate cancer were randomly assigned to active monitoring (surveillance strategy), radical prostatectomy, or three-dimensional conformal external-beam radiotherapy by a computer-generated allocation system. Randomisation was stratified by site (minimised for differences in participant age, PSA results, and Gleason score). The primary endpoint is prostate cancer mortality at a median 10-year follow-up, ascertained by an independent committee, which will be analysed by intention to treat in 2016. This trial is registered with ClinicalTrials.gov , number NCT02044172 , and as an International Standard Randomised Controlled Trial, number ISRCTN20141297. Findings Between Oct 1, 2001, and Jan 20, 2009, 228 966 men were invited to attend an appointment with a specialist nurse. Of the invited men, 100 444 (44%) attended their initial appointment and 82 429 (82%) of attenders had a PSA test. PSA concentration was below the biopsy threshold in 73 538 (89%) men. Of the 8566 men with a PSA concentration of 3·0–19·9 μg/L, 7414 (87%) underwent biopsies. 2896 men were diagnosed with prostate cancer (4% of tested men and 39% of those who had a biopsy), of whom 2417 (83%) had clinically localised disease (mostly T1c, Gleason score 6). With the addition of 247 pilot study participants recruited between 1999 and 2001, 2664 men were eligible for the treatment trial and 1643 (62%) agreed to be randomly assigned (545 to active monitoring, 545 to radiotherapy, and 553 to radical prostatectomy). Clinical and sociodemographic characteristics of randomly assigned participants were balanced across treatment groups. Interpretation The ProtecT trial randomly assigned 1643 men with localised prostate cancer to active monitoring, radiotherapy, or surgery. Participant clinicopathological features are more consistent with contemporary patient characteristics than in previous prostate cancer treatment trials. Funding UK National Institute for Health Research Health Technology Assessment Programme.
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6Follow-Up Studies
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30Prostatic Neoplasms - pathology
31Prostatic Neoplasms - therapy
32Radiation therapy
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36Risk Assessment
37Surgery
38Survival Analysis
39Treatment Outcome
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titleActive monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial
authorLane, J Athene, PhD ; Donovan, Jenny L, Prof ; Davis, Michael, MSc ; Walsh, Eleanor, MSc ; Dedman, Daniel, MSc ; Down, Liz, BSc ; Turner, Emma L, PhD ; Mason, Malcolm D, Prof ; Metcalfe, Chris, PhD ; Peters, Tim J, Prof ; Martin, Richard M, PhD ; Neal, David E, Prof ; Hamdy, Freddie C, Prof
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jtitleThe Lancet Oncology
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abstractSummary Background Prostate cancer is a major public health problem with considerable uncertainties about the effectiveness of population screening and treatment options. We report the study design, participant sociodemographic and clinical characteristics, and the initial results of the testing and diagnostic phase of the Prostate testing for cancer and Treatment (ProtecT) trial, which aims to investigate the effectiveness of treatments for localised prostate cancer. Methods In this randomised phase 3 trial, men aged 50–69 years registered at 337 primary care centres in nine UK cities were invited to attend a specialist nurse appointment for a serum prostate-specific antigen (PSA) test. Prostate biopsies were offered to men with a PSA concentration of 3·0 μg/L or higher. Consenting participants with clinically localised prostate cancer were randomly assigned to active monitoring (surveillance strategy), radical prostatectomy, or three-dimensional conformal external-beam radiotherapy by a computer-generated allocation system. Randomisation was stratified by site (minimised for differences in participant age, PSA results, and Gleason score). The primary endpoint is prostate cancer mortality at a median 10-year follow-up, ascertained by an independent committee, which will be analysed by intention to treat in 2016. This trial is registered with ClinicalTrials.gov , number NCT02044172 , and as an International Standard Randomised Controlled Trial, number ISRCTN20141297. Findings Between Oct 1, 2001, and Jan 20, 2009, 228 966 men were invited to attend an appointment with a specialist nurse. Of the invited men, 100 444 (44%) attended their initial appointment and 82 429 (82%) of attenders had a PSA test. PSA concentration was below the biopsy threshold in 73 538 (89%) men. Of the 8566 men with a PSA concentration of 3·0–19·9 μg/L, 7414 (87%) underwent biopsies. 2896 men were diagnosed with prostate cancer (4% of tested men and 39% of those who had a biopsy), of whom 2417 (83%) had clinically localised disease (mostly T1c, Gleason score 6). With the addition of 247 pilot study participants recruited between 1999 and 2001, 2664 men were eligible for the treatment trial and 1643 (62%) agreed to be randomly assigned (545 to active monitoring, 545 to radiotherapy, and 553 to radical prostatectomy). Clinical and sociodemographic characteristics of randomly assigned participants were balanced across treatment groups. Interpretation The ProtecT trial randomly assigned 1643 men with localised prostate cancer to active monitoring, radiotherapy, or surgery. Participant clinicopathological features are more consistent with contemporary patient characteristics than in previous prostate cancer treatment trials. Funding UK National Institute for Health Research Health Technology Assessment Programme.
copEngland
pubElsevier Ltd
pmid25163905
doi10.1016/S1470-2045(14)70361-4
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