Clinical (non-histological) diagnosis of advanced prostate cancer: Evaluation of treatment outcome after androgen deprivation therapy.

Introduction. Transrectal biopsy in suspected adenocarcinoma of the prostate (ACP) may cause significant morbidity and even mortality. A strong association between serum prostate-specific antigen (PSA) and tumour burden exists. If biopsy can be avoided in advanced disease, much morbidity and cost may be saved.Objective. To evaluate the reliability of using PSA and clinical features to establish a non-histological diagnosis of ACP.Methods. Androgen deprivation therapy (ADT) was used in 825 (56.2%) of 1 467 men with ACP. The diagnosis of ACP was made histologically in 607 patients (73.6%) and clinically alone in 218 (26.4%), based on a serum PSA level of >60 ng/ml, and/or clinical evidence of a T3 - T4 tumour on digital rectal examination, and/or imaging evidence of metastases. We compared two randomly selected groups treated with bilateral orchidectomy (BO) based on a clinical-only (n=90) v. histological (n=96) diagnosis of ACP.Results. There was no significant difference between the groups with regard to mean follow-up (26.1 v. 26.8 months), documented PSA relapse (70% v. 67.7%), and patients alive at last follow-up (91.1% v. 95.8%). ZAR1 068 200 (US$1 = ZAR8) was saved by treating men with advanced ACP on the basis of a clinical (non-histological) diagnosis only, and a total of ZAR24 321 000 was saved by using BO instead of luteinising hormone-releasing hormone agonists as ADT.Conclusion. A reliable clinical (non-histological) diagnosis of advanced ACP can be made based on serum PSA and clinical features. This avoids the discomfort and potentially serious complications of biopsy and saves cost.