Urological oncology

Böhle, Andreas

doi:10.1590/S1677-55382003000500021

UROLOGICAL SURVEY

Urological oncology

Long-term followup of a randomized trial of 0 versus 3 months of neoadjuvant androgen ablation before radical prostatectomy

Klotz LH, Goldenberg SL, Jewett MA, Fradet Y, Nam R, Barkin J, Chin J, Chatterjee S; Canadian Uro-Oncology Group

Division of Urology, Sunnybrook and Women's College Health Sciences Centre MG408, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada

J. Urol. 2003; 170: 791-4

PURPOSE: 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.

MATERIALS AND METHODS: 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.

RESULTS: 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).

CONCLUSIONS: 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.

Editorial Comment

Once upon a time, neoadjuvant hormonal therapy before prostatectomy was a hit on our congresses. We were told that surgical margins were less positive, and we should do that in every case. After several years now this claim is indeed history. Neoadjuvant hormonal therapy before prostatectomy did not translate in improved survival. With regard to side effects and the psychological impacts of this therapy on men this should not be advocated anymore.

Dr. Andreas Böhle

Professor of Urology

HELIOS Agnes Karll Hospital

Bad Schwartau, Germany

A seven-year follow-up of men following a benign prostate biopsy

Boddy JL, Pike DJ, Malone PR

Department of Urology, Royal Berkshire and Battle Hospitals, Oxford Road, Reading RG30 1AG, UK

Eur Urol. 2003; 44: 17-20

OBJECTIVES: To determine the incidence and clinical relevance of newly diagnosed cases of prostate cancer in a group of men who had an elevated PSA and benign prostate biopsy 7 years previously.

PATIENTS AND METHOD: Patients under the age of 80 years with an elevated PSA who had had a benign prostate biopsy in the 12 months between March 1, 1994 and February 28, 1995 were studied. One hundred and sixty four patients with a mean age of 66.8 years (range 47 - 79 years) were identified. The mean PSA for this group was 10.3 ng/ml (range 4.1 - 81 ng/ml). One hundred and fifty nine of the 164 (97%) hospital records were available for review and all but 21 (12.8%) of the General Practitioners were contacted.

RESULTS: Eighteen (11%) of the original 164 patients were subsequently diagnosed with prostate cancer, 2 died from their disease.

CONCLUSIONS: In a population where the follow-up of patients with a benign biopsy was arranged on clinical grounds alone, 11% of the study group was diagnosed with prostate cancer during a seven-year follow-up. Although some of these cancers appear to be slow growing, most of those diagnosed in the initial follow-up period were deemed to be clinically significant and a small proportion progressed rapidly to metastases. All patients who have an elevated PSA, but benign biopsy, should undergo a period of PSA monitoring until it is clear that their PSA is not rising. We propose an initial intensive monitoring period to avoid missing those with clinically aggressive disease.

Editorial Comment

Transrectal ultrasound guided biopsy of the prostate is not 100% sensitive and the false negative biopsy rate is estimated at 20 - 30 %. Only few papers address these missed cases and therefore, this contribution is worthwhile reading. 164 patients had negative biopsy of their prostate. 40% underwent TURP, and of these 69 underwent 1 or 2 TURPs. 7 of these patients had cancer. 53 patients had one or more TRUS biopsies, 13 were found with cancer. Interestingly, of the 18 patients diagnosed with prostate cancer, 3 were diagnosed within 12 months of their initial biopsy. 3 patients were found to have bone metastasis at this time, indicating an aggressive disease.

With these results in background the authors concluded correctly, that all patients, who have a suspicious PSA, but a negative biopsy should undergo an intensive monitoring period and PSA monitoring until it is clear that PSA is not rising.