Methods in Pharmacoepidemiology / Study Design

6G-03 - Comparison of baseline characteristics in patients with prostate cancer who received radical prostatectomy or external beam radiotherapy: target trial versus real-world data population

Tuesday, August 26, 2025

2:00 PM - 2:15 PM ET

Presenting Author(s)

Eng Hooi (Cheryl) Tan

University of Oxford, United Kingdom

Co-Author(s)

DN

Danielle Newby

University of Oxford, United Kingdom
WM

Wai Yi Man

University of Oxford, United Kingdom
Antonella Delmestri, PhD

Lead Health Data Scientist
University of Oxford, England, United Kingdom
NS

Nora Tabea Sibert

Health Services Research Department, German Cancer Society, Berlin, Germany, Germany
RN

Rossella Nicoletti

Department of clinical and experimental medicine, University of Florence, Italy, Italy
PW

Peter-Paul Willemse

Department of Urology, Cancer Center, UMC Utrecht, The Netherlands, Netherlands
MR

Monique Roobol

Erasmus University Medical Centre, Cancer Institute, Department of Urology, Rotterdam, The Netherlands, Netherlands
DN

Daan Nieboer

Erasmus University Medical Centre, Cancer Institute, Department of Urology, Rotterdam, The Netherlands, Netherlands
DP

Daniel Prieto-Alhambra

Health Data Sciences, Centre for Statistics in Medicine, University of Oxford, United Kingdom
OC

OPTIMA Consortium

OPTIMA consortium, United Kingdom

Background: The UK ProtecT trial was conducted to compare the effectiveness and safety of active surveillance, radical prostatectomy (RP), and external beam radiotherapy (EBRT) arms in prostate cancer (PC). Restrictive eligibility criteria under-represent patients in clinical practice who are older and less healthy. It is important to understand the difference in patient characteristics between those who received treatment in clinical practice versus trial population as this could affect the generalisability of trial results.

Objectives: To describe and compare the characteristics of patients who received RP or EBRT in real world data (RWD) vs target trial (TT) in UK

Methods: Male patients aged ≥ 18 years with a first RP or EBRT between 01 Jan 2010 to 31 Dec 2022 were selected from the Clinical Practice Research Datalink Aurum, a primary care database in the UK linked with hospital admissions, cancer registry, and death data. Our RWD cohort was made of patients with ≥1 year of data availability and PC diagnosis recorded in the 180 days before index date (date of RP or EBRT). We defined a target trial (TT) cohort to mimic the eligibility criteria in ProtecT. To avoid misclassification of index date, trial emulation was only performed in RP and EBRT groups in routinely collected data. The TT cohort comprised patients with PC diagnosed at age 50- 69, AJCC/UICC stage 1 or 2, baseline prostate specific antigen 3 to 19.99 ng/mL, no other malignancy, kidney transplant, bilateral hip replacement any time pre-index, and no COPD, heart failure, stroke, or myocardial infarction in the year pre-index. We characterised participants in the RWD and TT cohorts in terms of demographics, baseline comorbidities and oncological characteristics.

Results: For RP, we included 2,246 in TT and 11,385 in RWD. For EBRT, we included 419 in TT and 7,470 in RWD. Median age was older in the RWD vs TT in both treatment groups (RP: 65 vs 63; EBRT: 72 vs 66). Tumour size T1/T2 occurred in 46% of included men in RWD for both RP and EBRT. Of those with an available Gleason score, there was a lower proportion with Gleason grade 1 (low risk) in the RWD group (RP: 11% vs 16%; EBRT: 11% vs 24%). In RWD vs TT, prevalence of hypertension (41% vs 40%) and cardiovascular disease (CVD) (61% vs 64%) was similar in the RP group but higher for RWD in EBRT (hypertension: 55% vs 46%; CVD: 75% vs 64%)

Conclusions: Patients receiving RP in routine care are younger and have fewer comorbidities than EBRT. Those who received RP and EBRT in RWD have more advanced disease than TT participants. Particularly for EBRT, patients were older and had more comorbidities than the trial population.