Introducing the JUPITER project

A promising step towards evidence-based focal therapy for PCa

Dr. Eric Barret Institut Mutualiste Montsouris Paris (FR)

in patients with clinically localised PCa. Due to the lack of high-quality evidence, the JUPITER study has been developed.

eric.barret@imm.fr jims09@me.com

JUPITER is a new prospective multicentre (and not randomised) European registry for patients undergoing FT for localised prostate cancer. It has been developed under the umbrella of the EAU Research Foundation who will set up the database using the Castor study management system. The principal investigators and directors of the research are Dr. Eric Barret (FR) and Prof. Juan MartinezSalamanca (ES).

In recent years the earlier diagnosis of prostate cancer (PCa) and the increased detection of small and clinically insignificant PCa has highlighted the need to reduce possible overtreatment and preserve a patient’s quality of life (QoL). In this context, focal therapy (FT) represents an ideal therapeutic option to achieve these objectives in selected patients and is a hot research topic in this field. Already in 2018, FT was considered as a possible and significant option for PCa care [1]. The most recent systematic review concluded that “more high-quality evidence is required before FT can become a standard treatment” [2]. The current EAU guidelines [2] recommend that FT can be applied “within a clinical trial setting or well-designed prospective cohort study” and states that “sufficient data are available to form the basis of some initial judgements” for FT

At least 1,000 patients will be recruited for 2 years in European centres already experienced in FT. Inclusion criteria are related to: patients characteristics (age ≥ 18 years, WHO performance status 0 or 1, no prior treatment for PCa and diagnosis of intermediate-risk PCa according to D’Amico’s 2003 risk group categories), mpMRI findings (detection of single lesion suspected PCa lesion on mpMRI < T3, with PI-RADS ≥ 3 and tumour localisation according to the segmentation model used in PI-RADS v2), biopsy modalities (with a systematic biopsy US-MRI fusion technique performed with a number of cores ≥ 3 per target), and pathological analysis (ISUP 2 or 3 within the target, with ISUP 1 outside the target acceptable if low volume).

The primary endpoint of JUPITER is the oncological efficacy of FT for localised PCa at 12 months follow up, using several energy sources currently available. The secondary end points include the outcomes by energy, based on MRI, PSA changes and control biopsy, up to 60 months following the treatment.

Finally, in case of failure, the salvage treatments and their complications will be analysed.

If the study proves FT to be oncologically safe, and reduces the impact on patients’ urinary and sexual functions, it could become a valuable evidence-based therapeutic tool for both patients and urologists.

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Reference

1. van der Poel HG, van den Bergh RCN, Briers E, et al. Focal therapy in primary localised prostate cancer: The European Association of Urology position in 2018. Eur Urol. 2018;74(1):84-91. doi:10.1016/j.eururo.2018.01.001

2. Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Fütterer JJ, Rovers MM. An updated systematic review on focal therapy in localised prostate cancer: What has changed over the past 5 Years? Eur Urol. 2022;81(1):533. doi:10.1016/j.eururo.2021.08.005

3. EAU Guidelines. Edn. presented at the EAU Annual Congress Amsterdam 2022. ISBN 978-94-92671-16-5