To describe the development and first outcomes of the Utrecht Prostate Cohort (UPC): the first 'trials within cohorts' (TwiCs) platform for prostate cancer (PCa).
All non-metastasized, histologically proven PCa patients who are planned to receive standard of care are eligible for inclusion in UPC. Patients provide informed consent for the collection of clinical and technical patient data, physician-reported outcomes, and patient-reported outcomes (PROs) up to 10 years post-treatment. Additionally, patients may provide broad consent for future randomization for experimental-intervention trials (TwiCs). Changes in PROs (EPIC-26 questionnaire domains) of the participants who received standard of care were analyzed using Wilcoxon signed-rank tests.
In two years, 626 patients were enrolled, 503 (80.4%) of whom provided broad consent for future randomization. Among these, 293 (46.8%) patients underwent magnetic resonance-guided adaptive radiotherapy (MRgRT), 116 (18.5%) CT-guided external beam radiation therapy (EBRT), 109 (17.4%) robot-assisted radical prostatectomy (RARP), and 65 (10.4%) patients opted for active surveillance. Patients treated with MRgRT and CT-guided EBRT showed a transient but significant decline in urinary irritative/obstructive and bowel domain scores at 1-month follow-up. RARP patients showed a significant deterioration of urinary incontinence domain scores between baseline and all follow-up moments and significant improvement of urinary irritative/obstructive domain scores between baseline and 9- and 12-month follow-up. All radical treatment groups showed a significant decline in sexual domain scores during follow-up. Active surveillance patients showed no significant deterioration over time in all domains.
The first results from the UPC study show distinct differences in PROs between treatment options for PCa.
NCT04228211.
World journal of urology. 2022 Jul 21 [Epub ahead of print]
Frederik R Teunissen, Thomas Willigenburg, Richard P Meijer, Harm H E van Melick, Helena M Verkooijen, Jochem R N van der Voort van Zyp
Department of Radiation Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CZ, Utrecht, The Netherlands. ., Department of Radiation Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CZ, Utrecht, The Netherlands., Department of Oncologic Urology, University Medical Center Utrecht, Utrecht, The Netherlands., Department of Urology, St. Antonius Hospital, Nieuwegein, Utrecht, The Netherlands., Imaging Division, University Medical Center Utrecht, Utrecht, The Netherlands.