Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy

Titre officiel

Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy

Sommaire:

L’objectif de cette étude est de mettre au point et d’évaluer une technique de curiethérapie à bas débit de dose (BDD) guidée par fusion échographie 3D et résonance magnétique (RM), qui épargne de manière significative les faisceaux neurovasculaires prostatiques (un faisceau de nerfs et de vaisseaux qui parcourent la prostate) et le bulbe du pénis (base du pénis), tout en essayant de traiter efficacement le cancer de la prostate.

Description de l'essai

Primary Outcome:

• Rate of patients receiving this experimental brachytherapy technique and achieving acceptable dose distribution at 1-month post-implant.

Secondary Outcome:

• Number of patient with preserved erectile function Erectile Function (IIEF) >= 18)
• Post-procedure PSA dynamic
• Acute and long-term GU and GI toxicity
• Biochemical failure
• Local recurrence

Low dose rate (LDR) brachytherapy is an excellent treatment strategy for patients with prostate confined cancers, achieving high curative rates. However, LDR brachytherapy has been linked with long-term erectile dysfunction (ED), with a broad range of reported incidence in the literature. The pathophysiology associated with ED is complex and variable among different prostate cancer treatment strategies. In the post radical prostatectomy (RP) setting, ED is usually an immediate phenomenon and associated with neuropraxia caused by trauma and inflammation (Nandipati 2006). On the contrary, external beam radiation therapy (EBRT) related ED frequently occurs between 6-24 months and is believed to be vasculogenic in nature and caused by veno-vascular luminal occlusion (Mulhall et al. 2005) that culminates into fibrosis of the corporal tissue. In the post brachytherapy setting, seems plausible that a combination of both nerve and vascular damage are involved in the ED pathogenesis as erectile scores seem to reduce in the first months post implant (likely due to trauma) followed by a subsequent recovery and then, a gradual decline (Mabjeesh 2005). Despite a more complex pathophysiology, rates of ED post LDR brachytherapy seem to be lower than post EBRT or RP treatment (Crook 2010, Putora 2015). This may be associated with a significantly lower degree of trauma to the surrounding healthy tissue compared with trauma caused by RP and a more conformal dose around the prostate when contrasted with EBRT. In this regard, brachytherapy delivers a lesser dose to important structures previously correlated with an erectile function such as the internal pudendal artery (IPA), penile bulb, corpus cavernosum and possibly the neurovascular bundle. Currently, some strategies have been developed in an attempt to minimize ED post radiation therapy. In the POTEN-C clinical trial (NCT03525262), 120 patients are being randomized to stereotactic ablative radiation therapy with or without neurovascular sparing (neurovascular bundle, IPA and penile bulb/corpus carvenosum) with ED as the primary endpoint. Although the concept is intriguing, LDR brachytherapy has superior dose conformality and hence, a better chance to reduce radiation dose to the surrounding structures involved in the erectile function while still effectively treating the prostate cancer.

Voir cet essai sur ClinicalTrials.gov