Randomized Phase II Trial Evaluation Of Erectile Function After Attempted Unilateral Cavernous Nerve-Sparing Retropubic Radical Prostatectomy
UroToday.com - In 1999, Kim et al. from Baylor College of Medicine reported promising potency results from bilateral interposition of sural nerve grafts after bilateral non nerve sparing radical prostatectomy (RP). Our institution was able to duplicate these findings in the bilateral graft model as well. However, we were not sure how to properly analyze the efficacy of a unilateral nerve sparing plus unilateral non-nerve sparing with and without a unilateral sural nerve graft.
The difficulties were several-fold: the nerve-sparing alone may account for potency, patients requesting graft may have different baseline function, and patients requesting grafts may have different rates of “penile rehabilitation” compliance. Despite these uncertainties, many patients were willing to pay out-of-pocket for a plastic surgeon to place a graft with the rationale that they had that one opportunity to improve their potency preservation, while still having a nerve resected if their surgeon felt exptraprostatic disease was a significant risk. In fact, our center has experience with another 180 bilateral/unilateral graft cases in addition to the 107 randomized to this trial.
The trial was designed to enroll potent men 65 years and younger who were recommended to have a unilateral nerve sparing (UNS) RP due to the extent of biopsies. This was a popular management option for the late 1990’s as the concept of sparing a nerve on the side of a positive biopsy (sextant) was very early. The trial was randomized with a 3:2 ratio graft to control, with the incentive that if randomized to the graft, the plastic surgery fees were waived. Many men continued to request an off protocol graft and pay the out of pocket expenses, and in the later years we stopped offering this option due to the importance of finishing this trial. Both groups of men were counseled to participate in an aggressive penile rehabilitation program to include Sildenafil, vacuum erection device, and injections. The statistical design assumed a control rate of potency of 40% at 2 years, and a graft potency rate of 60% at 2 years - 200 patients would provide 80% power. The trial was designed to be a phase II single institution trial that if possible would be expanded into a phase III multi-institutional trial.
At an interim analysis of 107 patients, enough patients had 2 year follow-up to perform a planned statistical test for futility, which in fact showed a > 95% chance that the trial would be negative. In addition, accrual to the trial decreased to 2/month with the rising feasibility of performing a bilateral nerve sparing procedure.
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UroToday.com - Protocol 30846 of the EORTC-GU Group recruited 234 patients with histologically proven lymph node positive disease (pN1-3) according to the TNM classification of 1992. This included regional but not para-aortic lymph node disease. At the time the study was initiated in 1983, lymph node positive disease was encountered in 20 to 50% of cases that were clinically considered to be eligible for radical prostatectomy or radiotherapy. Also, except for the reported experience of the MAYO Clinic where in lymph node positive disease immediate endocrine treatment was combined with removal of the primary tumour, the best management of the primary tumour in this setting was unknown. There was no evidence from randomised studies on this issue. Considering ignorance about the best management of lymph node positive disease, the EORTC-GU Group deemed this group of patients as suitable to study the open issue of the best timing of endocrine intervention in prostate cancer and wished to make a contribution to a better understanding of the timing of endocrine treatment in this disease in general. This question, unfortunately, has still remained open today, 15 years after the design of this protocol.
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