Abstract
BACKGROUND
Between 1999 and 2009 in the United Kingdom, 82,429 men between 50 and 69 years of age received a prostate-specific antigen (PSA) test. Localized prostate cancer was diagnosed in 2664 men. Of these men, 1643 were enrolled in a trial to evaluate the effectiveness of treatments, with 545 randomly assigned to receive active monitoring, 553 to undergo prostatectomy, and 545 to undergo radiotherapy.
METHODS
At a median follow-up of 15 years (range, 11 to 21), we compared the results in this population with respect to death from prostate cancer (the primary outcome) and death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy (secondary outcomes).
RESULTS
Follow-up was complete for 1610 patients (98%). A risk-stratification analysis showed that more than one third of the men had intermediate or high-risk disease at diagnosis. Death from prostate cancer occurred in 45 men (2.7%): 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the prostatectomy group, and 16 (2.9%) in the radiotherapy group (P=0.53 for the overall comparison). Death from any cause occurred in 356 men (21.7%), with similar numbers in all three groups. Metastases developed in 51 men (9.4%) in the active-monitoring group, in 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group. Long-term androgen-deprivation therapy was initiated in 69 men (12.7%), 40 (7.2%), and 42 (7.7%), respectively; clinical progression occurred in 141 men (25.9%), 58 (10.5%), and 60 (11.0%), respectively. In the active-monitoring group, 133 men (24.4%) were alive without any prostate cancer treatment at the end of follow-up. No differential effects on cancer-specific mortality were noted in relation to the baseline PSA level, tumor stage or grade, or risk-stratification score. No treatment complications were reported after the 10-year analysis.
CONCLUSIONS
After 15 years of follow-up, prostate cancer–specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer. (Funded by the National Institute for Health and Care Research; ProtecT Current Controlled Trials number, ISRCTN20141297. opens in new tab; ClinicalTrials.gov number, NCT02044172. opens in new tab.)
Between 1999 and 2009 in the United Kingdom, 82,429 men between 50 and 69 years of age received a prostate-specific antigen (PSA) test. Localized prostate cancer was diagnosed in 2664 men. Of these men, 1643 were enrolled in a trial to evaluate the effectiveness of treatments, with 545 randomly assigned to receive active monitoring, 553 to undergo prostatectomy, and 545 to undergo radiotherapy.
METHODS
At a median follow-up of 15 years (range, 11 to 21), we compared the results in this population with respect to death from prostate cancer (the primary outcome) and death from any cause, metastases, disease progression, and initiation of long-term androgen-deprivation therapy (secondary outcomes).
RESULTS
Follow-up was complete for 1610 patients (98%). A risk-stratification analysis showed that more than one third of the men had intermediate or high-risk disease at diagnosis. Death from prostate cancer occurred in 45 men (2.7%): 17 (3.1%) in the active-monitoring group, 12 (2.2%) in the prostatectomy group, and 16 (2.9%) in the radiotherapy group (P=0.53 for the overall comparison). Death from any cause occurred in 356 men (21.7%), with similar numbers in all three groups. Metastases developed in 51 men (9.4%) in the active-monitoring group, in 26 (4.7%) in the prostatectomy group, and in 27 (5.0%) in the radiotherapy group. Long-term androgen-deprivation therapy was initiated in 69 men (12.7%), 40 (7.2%), and 42 (7.7%), respectively; clinical progression occurred in 141 men (25.9%), 58 (10.5%), and 60 (11.0%), respectively. In the active-monitoring group, 133 men (24.4%) were alive without any prostate cancer treatment at the end of follow-up. No differential effects on cancer-specific mortality were noted in relation to the baseline PSA level, tumor stage or grade, or risk-stratification score. No treatment complications were reported after the 10-year analysis.
CONCLUSIONS
After 15 years of follow-up, prostate cancer–specific mortality was low regardless of the treatment assigned. Thus, the choice of therapy involves weighing trade-offs between benefits and harms associated with treatments for localized prostate cancer. (Funded by the National Institute for Health and Care Research; ProtecT Current Controlled Trials number, ISRCTN20141297. opens in new tab; ClinicalTrials.gov number, NCT02044172. opens in new tab.)
| Original language | English |
|---|---|
| Pages (from-to) | 1547-1558 |
| Number of pages | 12 |
| Journal | New England Journal of Medicine |
| Volume | 388 |
| Issue number | 17 |
| Early online date | 11 Mar 2023 |
| DOIs | |
| Publication status | Published - 27 Apr 2023 |
Bibliographical note
Funding Information:Methods of trial recruitment and the results of the primary and secondary outcomes at a median of 10 years of follow-up were published previously; trial-group assignments are shown in . The ProtecT trial was funded by the National Institute for Health and Care Research in the United Kingdom; the University of Oxford sponsored the trial management. The trial was approved by the East-Midlands Multicenter Research Ethics Committee. The trial was overseen by an independent trial steering committee throughout and by a separate data and safety monitoring committee until 2015. All the patients provided written informed consent. All the authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the , available with the full text of this article at NEJM.org.
Funding Information:
Supported by the Health Technology Assessment Program (projects 96/20/06, 96/20/99UK) of the National Institute for Health and Care Research (NIHR), with the University of Oxford as sponsor. Drs. Hamdy and Bryant are supported by the Oxford NIHR Biomedical Research Centre, Surgical Innovation and Evaluation Theme. Dr. Martin is supported by the Bristol NIHR Biomedical Research Centre (BRC-1215-20011) and the Cancer Research UK Integrative Cancer Epidemiology Program (C18281/A29019). Dr. Lane and Ms. Young are supported by the NIHR Bristol Trials Centre. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Funding Information:
Supported by the Health Technology Assessment Program (projects 96/20/06, 96/20/99UK) of the National Institute for Health and Care Research (NIHR), with the University of Oxford as sponsor. Drs. Hamdy and Bryant are supported by the Oxford NIHR Biomedical Research Centre, Surgical Innovation and Evaluation Theme. Dr. Martin is supported by the Bristol NIHR Biomedical Research Centre (BRC-1215-20011) and the Cancer Research UK Integrative Cancer Epidemiology Program (C18281/A29019). Dr. Lane and Ms. Young are supported by the NIHR Bristol Trials Centre.
Publisher Copyright:
© 2023 Massachusetts Medical Society.
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This is the accepted author manuscript (AAM). The final published version (version of record) is available online via Massachusetts Medical Society at 10.1056/NEJMoa2214122. Please refer to any applicable terms of use of the publisher.