Active 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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Summary
This summary is machine-generated.The Prostate testing for cancer and Treatment (ProtecT) trial found that 1643 men with localized prostate cancer were assigned to active monitoring, radiotherapy, or surgery. Participant characteristics in this trial align with current patient profiles.
Area Of Science
- Urology
- Oncology
- Public Health
Background
- Prostate cancer poses a significant public health challenge, with ongoing debate regarding the efficacy of population-wide screening and treatment modalities.
- The Prostate testing for cancer and Treatment (ProtecT) trial was initiated to address these uncertainties.
Purpose Of The Study
- To investigate the effectiveness of different treatment options for localized prostate cancer.
- To report the study design, participant characteristics, and initial findings of the ProtecT trial's testing and diagnostic phase.
Main Methods
- A randomized phase 3 trial involving men aged 50-69 years across 337 UK primary care centers.
- Participants underwent serum prostate-specific antigen (PSA) testing, with biopsies offered for PSA levels ≥3.0 microg/L.
- Eligible men with localized prostate cancer were randomized to active monitoring, radical prostatectomy, or radiotherapy.
Main Results
- Between 2001 and 2009, 100,444 men attended initial appointments, and 82,429 underwent PSA testing.
- Prostate cancer was diagnosed in 2896 men (4% of tested), with 2417 (83%) having localized disease.
- 1643 men agreed to randomization: 545 to active monitoring, 545 to radiotherapy, and 553 to radical prostatectomy.
Conclusions
- The ProtecT trial successfully randomized 1643 men with localized prostate cancer into three treatment arms: active monitoring, radiotherapy, and surgery.
- The clinicopathological features of participants in the ProtecT trial reflect contemporary patient populations more closely than in prior studies.