Comparative effectiveness and safety in patients with prostate cancer who received radical prostatectomy vs. radiotherapy: target trial emulation

Study type

• Study topic:
  Medical procedure
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  Adult men aged 18+ years on the date of receiving first radical prostatectomy or radiotherapy (index date) ; • At least 1 year of observation pre index date ; • No prior treatment for prostate malignancy ; • Clinically localised prostate cancer (T1-T2, NX, M0) or Stage 1-2 diagnosed with no M1 or Stage 3-4 diagnosis ;
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Study design details

• Study design:
  An international network cohort study using data mapped to the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). The study will use a new user design and compare patients who received radical prostatectomy to those who received radiotherapy for prostate cancer.
• Main study objective:
  1. To estimate the comparative effectiveness and safety of surgical versus radiological treatment of prostate cancer in the target trial population; 2. To estimate the comparative effectiveness and safety of surgical versus radiological treatment of prostate cancer in the real world data population;
• Setting:
  Additional criteria for target trial population ; • Clinically localised prostate cancer (T1-T2, NX, M0) or Stage 1-2 diagnosed in the 6 months pre index date ; • Age 50-69 years on the date of PCa diagnosis ; • PSA in the range 3.0-19.99 ng/ml in the year pre-index ; • No concomitant or past malignancies (other than a small treated skin cancer) ; • No serious cardiac or respiratory problems in the previous 12 months of the index date, i.e. stroke, MI, heart failure, COPD ; • No kidney dialyses or transplantation pre-index date ; • No bilateral hip replacement pre-index date ;
• Comparators:
  Radical prostatectomy vs radiotherapy (external beam radiotherapy, brachytherapy)
• Outcomes:
  Mortality (all-cause and cancer specific), disease progression (PSA biochemical recurrence, metastasis, initiation of long term hormone therapy), treatment complications (rectal/bowel injury/symptoms, sexual dysfunction, urethral stricture, lower urinary tract symptoms and treatment, incontinence and obstruction), depression and psychological state, metabolic syndrome, cardiovascular outcomes
• Data analysis plan:
  This study will follow the target trial emulation framework, using the ProtecT clinical trial as a benchmark. Propensity score methods will be used to adjust for confounding. Cox regression models will be used to estimate the hazard ratios of the outcomes.