The first patient-reported outcomes from the Utrecht Prostate Cohort (UPC): the first platform facilitating 'trials within cohorts' (TwiCs) for the evaluation of interventions for prostate cancer

Frederik R Teunissen; Thomas Willigenburg; Richard P Meijer; Harm H E van Melick; Helena M Verkooijen; Jochem R N van der Voort van Zyp

doi:10.1007/s00345-022-04092-2

The first patient-reported outcomes from the Utrecht Prostate Cohort (UPC): the first platform facilitating 'trials within cohorts' (TwiCs) for the evaluation of interventions for prostate cancer

World J Urol. 2022 Sep;40(9):2205-2212. doi: 10.1007/s00345-022-04092-2. Epub 2022 Jul 21.

Authors

Frederik R Teunissen¹, Thomas Willigenburg², Richard P Meijer³, Harm H E van Melick⁴, Helena M Verkooijen^{5

6}, Jochem R N van der Voort van Zyp²

Affiliations

¹ Department of Radiation Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CZ, Utrecht, The Netherlands. [email protected].
² Department of Radiation Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CZ, Utrecht, The Netherlands.
³ Department of Oncologic Urology, University Medical Center Utrecht, Utrecht, The Netherlands.
⁴ Department of Urology, St. Antonius Hospital, Nieuwegein, Utrecht, The Netherlands.
⁵ Imaging Division, University Medical Center Utrecht, Utrecht, The Netherlands.
⁶ Utrecht University, Utrecht, The Netherlands.

Abstract

Purpose: To describe the development and first outcomes of the Utrecht Prostate Cohort (UPC): the first 'trials within cohorts' (TwiCs) platform for prostate cancer (PCa).

Methods: 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.

Results: 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.

Conclusion: The first results from the UPC study show distinct differences in PROs between treatment options for PCa.

Registration no: NCT04228211.

Keywords: Cohort studies; Patient-reported outcome measures; Prostatic neoplasms; Quality of life; Treatment outcome.

Publication types

Clinical Trial

MeSH terms

Humans
Male
Patient Reported Outcome Measures
Prospective Studies
Prostate* / pathology
Prostatectomy / methods
Prostatic Neoplasms* / pathology
Quality of Life
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04228211

Grants and funding

104006004/ZonMW IMDI/LSH-TKI Foundation