Marra Giancarlo, Shah Taimur T, D'Agate Daniele, Marquis Alessandro, Calleris Giorgio, Lunelli Luca, Filippini Claudia, Oderda Marco, Gatti Marco, Valerio Massimo, Sanchez-Salas Rafael, Bossi Alberto, Gomez-Rivas Juan, Conte Francesca, Deandreis Desiree, Cussenot Olivier, Ricardi Umberto, Gontero Paolo
Department of Surgical Sciences and Urology Clinic, University of Turin and Città della Salute e della Scienza, Turin, Italy.
Department of Urology and Clinical Research Group on Predictive Onco-Urology, APHP, Sorbonne University Paris, Paris, France.
Front Surg. 2022 Jun 7;9:900528. doi: 10.3389/fsurg.2022.900528. eCollection 2022.
Currently, the majority of prostate cancer (PCa) recurrences after non-surgical first-line treatment are managed with androgen-deprivation therapy (ADT). Salvage radical prostatectomy (sRP) is a curative alternative to ADT but yields significant morbidity. Preliminary evidence from focal salvage treatments shows similar oncological control but lower morbidity compared to sRP. Among available ablative focal energies, irreversible electroporation (IRE) is a treatment modality that proved promising, especially in treating apical lesions, where PCa most often recurs. Our aim is to test the safety of salvage IRE for recurrent PCa.
We performed a single-arm pilot feasibility study (IDEAL stage 2a): SAFE, SAlvage Focal irreversible Electroporation for recurrent localized PCa. Twenty patients with biopsy-proven PCa recurrence after primary non-surgical (radiation or ablation) treatment were included. All men will undergo mpMRI ± targeted biopsies, pre-operative PSMA-PET staging before inclusion and sIRE. Outcomes will be evaluated through internationally validated questionnaires and morbidity scales. All men will undergo a control biopsy at one year.
Primary objectives were the evaluation of the safety of sIRE (and patients' quality of life) after treatment. Secondary objectives were the evaluation of functional outcomes, namely, continence and erectile function changes and evaluation of short-term oncological efficacy.
SAFE is the second pilot study to evaluate sIRE and the first one performed according to the most recent diagnostic and staging imaging standards. sIRE may provide a curative option for recurrent PCa together with lower comorbidities compared to sRP.
目前，非手术一线治疗后大多数前列腺癌（PCa）复发采用雄激素剥夺疗法（ADT）进行管理。挽救性根治性前列腺切除术（sRP）是ADT的一种治愈性替代方法，但会产生显著的发病率。局部挽救性治疗的初步证据表明，与sRP相比，其肿瘤学控制相似，但发病率较低。在现有的消融性局部能量中，不可逆电穿孔（IRE）是一种被证明有前景的治疗方式，尤其在治疗PCa最常复发的尖部病变方面。我们的目的是测试挽救性IRE治疗复发性PCa的安全性。
我们进行了一项单臂试点可行性研究（IDEAL 2a期）：SAFE，即用于复发性局限性PCa的挽救性局部不可逆电穿孔。纳入了20例经活检证实为原发性非手术（放疗或消融）治疗后PCa复发的患者。所有男性在纳入前将接受mpMRI ± 靶向活检、术前PSMA-PET分期以及sIRE。结果将通过国际认可的问卷和发病率量表进行评估。所有男性将在一年后接受对照活检。
主要目标是评估治疗后sIRE的安全性（以及患者的生活质量）。次要目标是评估功能结果，即控尿和勃起功能的变化，以及评估短期肿瘤学疗效。
SAFE是第二项评估sIRE的试点研究，也是根据最新诊断和分期成像标准进行的第一项研究。与sRP相比，sIRE可能为复发性PCa提供一种治愈选择，且合并症较少。
