Prospective study of diagnostic accuracy in the detection of high-grade prostate cancer in biopsy-naïve patients with clinical suspicion of prostate cancer who underwent the Select MDx test.

OBJECTIVES: This study aimed to externally validate the diagnostic accuracy of the Select MDx test for Significant prostate cancer (Sig PCa) (ISUP > 1), in a contemporaneous, prospective, multicenter cohort with a prostate-specific antigen (PSA) between 3 and 10 ng/ml and a non-suspicious digital rectal examination. METHODS AND PARTICIPANTS: For all enrolled patients, the Select Mdx test, the risk calculator ERSPC3 + DRE, and a prostatic magnetic resonance imaging (MRI) were carried out. Subsequently, a systematic 12-core trans-rectal biopsy and a targeted biopsy, in the case of a prostate imaging-reporting and data system (PIRADS) > 2 lesion (max three lesions), were performed. To assess the accuracy of the Select MDx test in the detection of clinically Sig PCa, the test sensitivity was evaluated. Secondary objectives were specificity, negative predictive value (NPV), positive predictive value (PPV), and area under the curve (AUC). A direct comparison with the ERSPC + DRE risk calculator and MRI were also performed. We also studied the predictive ability to diagnose Sig PCa from the combination of the Select MDx test with MRI using clinical decision-curve analysis. RESULTS: There were 163 patients enrolled after meeting the inclusion criteria and study protocol. The Select MDx test showed a sensitivity of 76.9% (95% CI, 63.2-87.5), 49.6% specificity (95% CI, 39.9-59.2), 82.09% (95% CI, 70.8-90.4) NPV, and 41.67% (95% CI, 31.7-52.2) PPV for the diagnosis of Sig PCa. COR analysis was also performed, which showed an AUC of 0.63 (95% CI, 0.56-0.71). There were no differences in the accuracy of Select MDx, ERSPC + DRE, or MRI. The combination of Select MDX + MRI showed the highest impact in the decision-curve analysis, with an NPV of 93%. CONCLUSION: Our study showed a worse performance for the SelectMdx test than previously reported, within a cohort of patients with a PSA 3-10 ng/ml and a normal DRE, with results similar to those from ERSPC + DRE RC and MRI, but with an improvement in the usual PSA pathway. A combination of the Select Mdx test and MRI could improve accuracy, but studies specifically evaluating this scenario with a cost-effective analysis are needed.

Transvaginal NOTES-assisted laparoscopic nephrectomy: a survival study in a sheep model.

BACKGROUND: This study aims to evaluate the feasibility and usefulness of an ovine model in order to perform natural orifice translumenal endoscopic surgery (NOTES) approach and laparoscopic nephrectomy for research and training purposes. METHODS: Ten healthy female sheep were used to perform transvaginal NOTES-assisted right laparoscopic nephrectomy using a flexible 12-mm gastroscope through a vaginal access and two additional 5- and 10-mm trocars placed in the abdomen. The renal artery, the renal vein, and the ureter were dissected, and ligation was accomplished by using laparoscopic clips. The right kidney was retrieved transvaginally after enlarging the vaginal trocar incision. All data related with the surgical procedure, perioperative, and postoperative outcomes were recorded. The animals were monitored after surgery for a 30-day period with daily clinical follow-up. RESULTS: We established a useful animal model of transvaginal NOTES-assisted laparoscopic nephrectomy, performing the transvaginal approach and the abdomen exploration with no complications in any animals. The renal artery, the renal vein, and the ureter were identified, clipped, and transected combining the 5-mm laparoscopic access and the endoscopic vision in the whole group. Mean operative time was 86 ± 14.49 min, estimated blood loss was less than 20 ml in all cases, and there was no bleeding or laceration of adjacent organs. The animals recovered successfully in all cases postoperatively. After 1 month, exploratory laparotomy did not show alterations in abdominal cavity, and the vaginotomy incision healed completely in every animal. CONCLUSIONS: This experiment shows that transvaginal NOTES-assisted laparoscopic nephrectomy in ovine model is feasible and reproducible while offering an innovative possibility to help surgeons with this recent technology in the treatment of renal cancer. Well-managed experimental studies need to be carried out to determine the safety and efficacy of NOTES in the treatment of renal cancer.