Klotz L H, Goldenberg S L, Jewett M A, Fradet Y, Nam R, Barkin J, Chin J, Chatterjee S
Division of Urology, Sunnybrook and Women's College Health Sciences Centre MG408, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.
J Urol. 2003 Sep;170(3):791-4. doi: 10.1097/01.ju.0000081404.98273.fd.
In 1992 we initiated a national randomized prospective trial of 3 months of cyproterone acetate before radical prostatectomy compared to prostatectomy alone. Initial results indicated a 50% decrease in the rate of positive surgical margins. This decrease did not translate into a difference in prostate specific antigen (PSA) progression at 3 years. This report is on the long-term outcome (median followup 6 years) of this cohort.
This prospective, randomized, open label trial compared 100 mg cyproterone acetate 3 times daily for 3 months before surgery to surgery alone. Randomization occurred between January 1993 and April 1994. Patients were stratified according to clinical stage, baseline serum PSA and Gleason sum. A total of 213 patients were accrued. Biochemical progression was defined as 2 consecutive detectable PSAs (greater than 0.2 ng/ml) at least 4 weeks apart, re-treatment or death from prostate cancer.
A total of 34 (33.6%) patients undergoing surgery only and 42 (37.5%) patients given neoadjuvant hormone therapy (NHT) had biochemical recurrence during the median followup of 6 years. Despite the significant pathological down staging in this study, there was no significant difference in number of patients with no evidence of biochemical disease (bNED) survival (p = 0.732). A bNED survival benefit favoring NHT was seen in men with a baseline PSA greater than 20 (p = 0.015).
After 6 years of followup there was no overall benefit with 3 months of NHT. Improved bNED survival was seen in the highest risk PSA group (PSA greater than 20). The possibility that high risk patients may benefit from NHT warrants further investigation.
1992年我们启动了一项全国性随机前瞻性试验，对比在根治性前列腺切除术前行3个月醋酸环丙孕酮治疗与单纯前列腺切除术的效果。初步结果显示手术切缘阳性率降低了50%。但这一降低并未转化为3年时前列腺特异性抗原（PSA）进展方面的差异。本报告是关于该队列的长期结果（中位随访6年）。
这项前瞻性、随机、开放标签试验将术前每天3次服用100毫克醋酸环丙孕酮，共3个月的治疗方案与单纯手术进行比较。随机分组于1993年1月至1994年4月进行。患者根据临床分期、基线血清PSA和Gleason评分进行分层。共招募了213例患者。生化进展定义为连续2次可检测到PSA（大于0.2纳克/毫升），间隔至少4周，再次治疗或死于前列腺癌。
在中位6年的随访期间，仅接受手术的34例（33.6%）患者和接受新辅助激素治疗（NHT）的42例（37.5%）患者出现了生化复发。尽管本研究中病理分期有显著下降，但无生化疾病证据（bNED）存活的患者数量无显著差异（p = 0.732）。在基线PSA大于20的男性中，观察到NHT在bNED存活方面有优势（p = 0.015）。
随访6年后，3个月的NHT无总体益处。在最高风险的PSA组（PSA大于20）中观察到bNED存活有所改善。高风险患者可能从NHT中获益这一可能性值得进一步研究。
