PURPOSE: We assessed the feasibility and efficacy of integrating chemotherapy and androgen ablation with radical prostatectomy in patients with locally advanced prostate cancer. The neoadjuvant approach was adopted because it allows an in situ assessment of antitumoral activity. PATIENTS AND METHODS: Thirty-three patients were enrolled who met the clinical criteria of stage T1–2, Gleason score of ≥ 8 or T2b-T2c, Gleason score of 7 and prostate-specific antigen (PSA) level greater than 10 ng/mL (n = 15), or clinical stage T3 (n = 18). Therapy consisted of 12 weeks of ketoconazole and doxorubicin alternating with vinblastine, estramustine, and androgen ablation followed by prostatectomy. The ability of neoadjuvant chemotherapy and hormonal therapy to induce a 20% rate of pT0 in the prostatectomy specimen as well as surgical feasibility were assessed. RESULTS: Chemotherapy complications were comparable to those reported with this regimen previously. No major intraoperative complications occurred. Postoperative complications occurred in 10 (33%) of 30 patients. One patient died at home after discharge (postoperative day 17; no autopsy was performed). Ten (33%) of the 30 patients had organ-confined disease, and 20 (70%) of 30 had extraprostatic extension; 11 (37%) of the 30 had positive lymph nodes. Only five (17%) of 30 exhibited positive surgical margins. All patients achieved an undetectable PSA level postoperatively, and 20 of the surviving 29 patients remain without disease recurrence with a median follow-up of 13 months (range, 9 to 18 months). CONCLUSION: Chemotherapy and androgen ablation followed by radical prostatectomy was feasible in patients with locally advanced prostate cancer. Although the goal of achieving a 20% rate for pT0 status was not achieved, we believe this type of integrated therapeutic strategy should be investigated further for its ability to alter the course of regionally advanced prostate cancer.
What's known on the subject? and What does the study add?: Several lymph node staging strategies have been proposed as a response to the high morbidity seen after standard inguinal lymphadenectomy for penile cancer. A video‐endoscopic (laparoscopic and robotic) approach has been proposed as a less morbid procedure in several retrospective studies. To date, none has evaluated the oncological adequacy with regard to whether all relevant nodes have been removed. To the authors’ knowledge this is the first prospective study of a robotic or laparoscopic inguinal lymphadenectomy that evaluates the oncological adequacy of this approach for penile cancer. The study shows that robotic inguinal lymphadenectomy allowed adequate staging of disease in the inguinal region by removing all relevant lymph nodes as assessed by an independent evaluating urological oncologist. Objective: To prospectively determine the oncological adequacy of robotic assisted video‐endoscopic inguinal lymphadenectomy ( RAVEIL ). Patients and Methods: Patients with T 1‐3 N 0 penile cancer were enrolled into a prospective phase I trial at a tertiary care institution from M arch 2010 to J anuary 2012. All patients underwent an initial RAVEIL approach. Verification of adequacy of dissection was performed by an independent surgeon via a separate open incision at the conclusion of the RAVEIL procedure. Out of 10 patients, if more than two superficial inguinal fields with ≥2 nodes or more than four with ≥1 node remained within the superficial dissection field, the study would not proceed to phase II . Results: Of 10 enrolled patients two had inguinal metastases and all positive nodes were detected by RAVEIL . The remaining eight patients had no metastases, with a mean of nine (range 5–21) left and nine (range 6–17) right nodes removed. One inguinal field RAVEIL was converted to an open dissection. The verifying surgeon confirmed that 18 of 19 inguinal fields (94.7% in nine patients) had an adequate dissection. Two benign nodes were found just beneath S carpa's fascia above the inguinal dissection field. Limitations of the study include an inability to determine decisively what specific wound complications were related to RAVEIL because of the protocol‐specified creation of a small inguinal incision for verification of adequate dissection. Conclusion: R AVEIL allowed adequate staging of disease in the inguinal region among patients with penile cancer at risk for inguinal metastases.