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Oncological Outcomes of Robot-assisted PSMA-guided Salvage Surgery in Recurrent Prostate Cancer: Insights from the Prospective TRACE-I Trial.

Lotte G Zuur ,
Hilda A de Barros ,
Vera A Ottens ,
Anne-Claire Berrens ,
Matthias N van Oosterom ,
Maarten L Donswijk ,
Jeroen J M A Hendrikx ,
Fijs W B van Leeuwen ,
Henk G van der Poel ,
Pim J van Leeuwen

Abstract

CONCLUSIONS

PSMA-RGS in the robotic setting for recurrent PCa shows an early PSA decline in almost all patients. Although biochemical progression after PSMA-RGS is common, PSMA-RGS presents an opportunity to prolong bPFS and TFS in a selection of patients.

RESULTS AND LIMITATIONS

Among 30 patients (19 RP, 9 RT, and 2 RP + RT), the median age was 68 yr, and the median PSA at RGS was 1.02 ng/ml (interquartile range, 0.46-2.86), 28 (93%) showed PSA decline after RGS, and 20 (66%) reached PSA <0.2 ng/ml or PSA nadir. The 1- and 2-yr bPFS were 40% and 30%; 2-yr dMFS and TFS were 62% and 58%, respectively. Recurrences were pelvic in 37% and distant in 40%. Limitations include single-centre design and small sample size.

BACKGROUND

Prostate-specific membrane antigen (PSMA)-radioguided surgery (RGS) is an emerging technique providing real-time intraoperative guidance. The prospective TRACE-I trial demonstrated that robot-assisted 99mtechnetium-PSMA-Investigation & Surgery-RGS ([99mTc]Tc-PSMA-I&S-RGS) using a DROP-IN gamma probe is feasible and safe in recurrent prostate cancer (PCa).

INTERVENTION

Patients underwent single-photon emission CT/CT and then robot-assisted PSMA-RGS.

OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS

Oncological outcomes were biochemical progression (PSA ≥0.2 ng/ml after RP or ≥2 ng/ml above nadir after RT), radiological recurrence on PSMA-PET/CT, and time to salvage therapy. Biochemical progression-free survival (bPFS), distant metastasis-free survival (dMFS), and therapy-free survival (TFS) were analysed using Kaplan-Meier and univariable Cox regression.

OBJECTIVE

To report the oncological outcmes of a post hoc analysis of the prospective TRACE-I trial cohort.

DESIGN, SETTING, AND PARTICIPANTS

TRACE-I prospectively enrolled 30 patients with biochemical recurrence (prostate-specific antigen (PSA) ≥0.2 ng/ml after radical prostatectomy (RP) or ≥2 ng/ml above nadir after radiotherapy (RT) and ≤3 pelvic recurrences (nodal and/or local) on PSMA-positron emission tomography/computed tomography (PET/CT; 2020-2023).

PATIENT SUMMARY

We updated outcomes from TRACE-I patients with recurrent prostate cancer. We found that PSMA-guided surgery led to PSA declines in most patients and delayed disease progression in some, but careful patient selection is essential.

More about this publication

European urology focus

Publication date 29-08-2026

Full text links

Publisher website (DOI) 10.1016/j.euf.2026.07.005
Europe PubMed Central 42668258
Pubmed 42668258

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