Active Surveillance in a Prostate Cancer Screening Trial in Young Men: Interim Results from the PROBASE Trial - European Medical Journal

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Active Surveillance in a Prostate Cancer Screening Trial in Young Men: Interim Results from the PROBASE Trial

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Urology
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Authors:
Maxime De Vrieze , 1 Rouvier Al-Monajjed , 2 Jale Lakes , 2 Kathleen Herkommer , 3 Jürgen E. Gschwend , 3 Lilly J. Schmalbrock , 3 Markus Kuczyk , 4 Nina N. Harke , 4 Jürgen Debus , 5 Christoph A. Grott , 5 Lisa-Marie Stertz , 5 Glen Kristiansen , 6 Lars Schimmöller , 7 Gerald Antoch , 8 Frederik Giesel , 9 Christian Arsov , 10 Boris Hadaschik , 11 Axel Benner , 12 Agne Krilaviciute , 1 Petra Seibold , 1 Rudolf Kaaks , 13 Nikolaus Becker , 1 * Peter Albers 1,2
  • 1. Division of Personalized Early Detection of Prostate Cancer, German Cancer Research Center (DKFZ), Heidelberg, Germany
  • 2. Department of Urology, University Hospital Düsseldorf, Medical Faculty, Heinrich-Heine University, Germany
  • 3. Department of Urology, Klinikum rechts der Isar, School of Medicine and Health, Technical University of Munich, Germany
  • 4. Department of Urology, Hannover Medical School, Germany
  • 5. Department of Radiation Oncology, Heidelberg University Hospital, Ruprecht Karls University Heidelberg, Germany
  • 6. Institute of Pathology, University of Bonn, University Hospital Bonn, Germany
  • 7. Department of Diagnostic, Interventional Radiology and Nuclear Medicine, Marien Hospital Herne, University Hospital of the Ruhr-University Bochum, Germany
  • 8. Department of Diagnostic and Interventional Radiology, University Hospital Düsseldorf, Medical Faculty, Heinrich-Heine University, Germany
  • 9. Department of Nuclear Medicine, University Hospital Düsseldorf, Medical Faculty, Heinrich-Heine University, Germany
  • 10. Department of Urology and Paediatric Urology, Elisabeth-Krankenhaus Rheydt, Städtische Kliniken Mönchengladbach, Germany
  • 11. Department of Urology, University Hospital Essen, University of Duisburg-Essen, Germany
  • 12. German Cancer Research Center (DKFZ), Heidelberg, Germany
  • 13. Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany
*Correspondence to [email protected]
Disclosure:

Hadaschik has grants from DFG, Novartis, BMS, Janssen, and Amgen; royalties or licenses from Uromed; consulting fees from Janssen, Bayer, Novartis, BMS, ABX, Merck, Onkowissen, Accord Healthcare, AstraZeneca, MSD/Pfizer, Amgen, Astellas, Lightpoint Medical, Point Biopharma, Ipsen, and Telix; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Janssen, Amgen, Astellas, Monrol, and Novartis; support for attending meetings and/or travel from Janssen, AstraZeneca, Bayer, BMS, Ipsen, and Amgen; participation on a Data Safety Monitoring Board or Advisory Board with Janssen, ABX, Telix, and Novartis; leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid from DGU. The other authors have declared no conflicts of interest.

Acknowledgements:

Published on behalf of the PROBASE study group and investigators.

Citation:
EMJ Urol. ;13[1]:40-41. https://doi.org/10.33590/emjurol/SFYY3996.
Keywords:
Active surveillance (AS), prostate cancer (PCa), risk-adapted screening.

Each article is made available under the terms of the Creative Commons Attribution-Non Commercial 4.0 License.

INTRODUCTION AND OBJECTIVES

The German PROBASE trial is an ongoing, randomised, risk-adapted prostate cancer (PCa) screening trial that primarily evaluates the start of prostate-specific antigen (PSA)-based screening at 45 versus 50 years.1-3 Active surveillance (AS) is a treatment option that may reduce treatment-related harms in clinically insignificant screen-detected PCa, especially in younger men.4 In this analysis, the authors present the first interim results of AS as a treatment modality within PROBASE.

MATERIALS AND METHODS

Basic descriptive statistics were used to report treatment choices and outcomes. A Kaplan–Meier time-to-event analysis was performed to analyse the rate of AS discontinuation. Since the start of the study in 2014, 364 PCa cases out of 46,495 PROBASE participants were registered at the time of data extraction (October 1, 2024). This analysis was limited to International Society of Urological Pathology (ISUP) Grade Group (GG) 1 (n=83) and 2 (n=158) PCa cases with available first-line treatment data. For the Kaplan–Meier analysis, participants who either withdrew from the study (n=2) or were lost to follow-up (n=14) after the start of AS were excluded.

RESULTS

The median age at PCa diagnosis was 50 years (interquartile range [IQR]: 47–51). A total of 91 patients started AS, including 72% of men diagnosed with ISUP GG 1 PCa (n=60). The remainder of ISUP GG 1 and 2 patients (n=150) underwent up-front radical prostatectomy (RP) or radiotherapy. Figure 1 shows the course of AS over time since the start of the AS protocol. The median time on AS was 41.2 months. In 85% (95% CI: 74.9–96.1%), 60% (95% CI: 45.3–78.8%), and 40% (95% CI: 24.2–65.1%) of men, AS delayed definitive treatment for at least 2, 3, and 4 years, respectively. So far, 19 patients have discontinued AS, with a median time to radical treatment of 24 months (IQR: 15–33; range 7–46). Importantly, of 13 patients with documented repeat biopsy prior to AS discontinuation, only seven had histological tumour upgrading (≥ISUP GG2 with >10% Gleason pattern 4) as a hard criterion for AS discontinuation.

Few of the 13 cases with available RP pathology reports had adverse pathological outcomes (R1: 3/13, pT3-4: 1/13, pN1: 0/13, ISUP GG 3–5: 0/13) at RP after AS discontinuation. After RP, 12 of 14 patients had a complete PSA response and remained free of biochemical recurrence with a median follow-up of 25.5 months (IQR: 13.5–35.4; range 5.3–66.5).

Figure 1: Course of active surveillance for International Society of Urological Pathology Grade Group 1 and 2 prostate cancer in PROBASE.
AS: active surveillance.

CONCLUSION

In PROBASE, AS deferred definitive treatment in half of the young men with low-risk and favourable intermediate-risk screen-detected PCa by nearly 3.5 years or longer, with acceptable short-term oncological outcomes after RP following AS discontinuation.

References
De Vrieze M et al. Active surveillance in a prostate cancer screening trial in young men: interim results from the PROBASE trial. A0023. EAU25, 21-24 March, 2025. Arsov C et al. Prospective randomized evaluation of risk-adapted prostate-specific antigen screening in young men: the PROBASE trial. Eur Urol. 2013;64(6):873-5. Arsov C et al. A randomized trial of risk-adapted screening for prostate cancer in young men—results of the first screening round of the PROBASE trial. Int J Cancer. 2022;150(11):1861-9. Hamdy FC et al. Fifteen-year outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med. 2023;388(17):1547-58.

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