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And Prostatic Acid Phosphatase (PAP) in Men with Benign Prostatic Hyperplasia (BPH)

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And Prostatic Acid Phosphatase (PAP) in Men with Benign Prostatic Hyperplasia (BPH) Prostate Cancer and Prostatic Diseases (2001) 4, 173–177 ß 2001 Nature Publishing Group All rights reserved 1365–7852/01 $15.00 www.nature.com/pcan Effects of bicalutamide and leuprolide on prostate-specific antigen (PSA), acid phosphatase (ACP) and prostatic acid phosphatase (PAP) in men with benign prostatic hyperplasia (BPH) LM Eri1* & KJ Tveter1 1Department of Urology, Ullevaal University Hospital, Oslo, Norway The effects of the nonsteroidal antiandrogen bicalutamide (CasodexTM) and the luteinizing hormone releasing hormone agonist leuprolide depot (Procren DepotTM, Lupron DepotTM) on serum prostate-specific antigen (PSA), acid phosphatase (ACP), and prostatic acid phosphatase (PAP) in patients with benign prostatic hyperplasia (BPH) were determined. Thirty patients with BPH were randomised to receive bicalutamide 50 mg orally once daily or a placebo for 24 weeks, followed by 24 weeks of follow-up (bicalutamide study). In another study 55 men were randomised between 3.75 mg leuprolide depot intramuscularly at every 28 days for 24 weeks or placebo injections (leuprolide study). In both studies blood sampling was performed at baseline, at week 12 at week 24 and 24 weeks after the end of therapy. Androgen suppression with bicalutamide 50 mg daily for 24 weeks resulted in a median of 56% reduction of PSA (P < 0.001 when compared to placebo). Acid phosphatase and PAP did not change. Leuprolide resulted in a median of 87% reduction of serum PSA (P < 0.001) and a 39% reduction of PAP (P ¼ 0.023), whereas ACP was unchanged. Both bicalutamide and leuprolide induced a pronounced decline in serum PSA in BPH patients. The studies suggest a stronger androgen suppressive effect of leuprolide than of bicalutamide, but this difference might largely be due to too low a dosage of bicalutamide. ACP and PAP were relatively insensitive to androgen suppression. Our study suggests a different degree of androgen suppression on PSA origi- nating from benign tissue versus cancer tissue, and that the direction of this discrepancy might be different for various androgen suppressive regimens. Prostate Cancer and Prostatic Diseases (2001) 4, 173–177. Keywords: prostatic hypertrophy; androgen antagonists; gonadorelin; bicalutamide; prostate-specific antigen; acid phosphatase Introduction effects of two forms of androgen suppression on prostate- specific antigen (PSA), acid phosphatase (ACP) and pro- In two prospective, placebo controlled studies of patients static acid phosphatase (PAP). Because of side effects and with benign prostatic hyperplasia (BPH) we assessed the high cost, BPH patients are nonroutinely treated with these drugs, and the results of our studies are of limited clinical interest for this patient group. However, nonster- *Correspondence: LM Eri, MD, Department of Urology, Aker University Hospital, 0514 Oslo, Norway. oidal antiandrogens and luteinising hormone-releasing Received 14 November 2000; revised 24 November 2000; hormone (LHRH) agonists are competing hormonal regi- accepted 29 November 2000 mens for the treatment of prostate cancer, and because Effects of bicalutamide and leuprolide LM Eri & KJ Tveter 174 there is a strong association between the relative fall in injections. For both studies the treatment period was 24 prostate-specific antigen PSA and outcome of treatment weeks followed by 24 weeks of follow-up. for individual patients with prostate cancer,1,2 PSA is Blood samples were drawn at weeks 0, 12, 24 and 48. widely used as a surrogate response parameter to Serum samples for PSA analyses were stored at 720C decide the relative effectiveness of various hormonal and serial analysed for PSA approximately 6 months after treatment regimens, and in dose ranging studies.1,3,4 completion of the studies, using the Abbott IMX radio- Our data are of interest in comparing the relative effec- immunoassay. ACP and PAP were analysed in the hospi- tiveness of these two forms of androgen suppression, but tal routine, using a radioimmunoassay technique. must be interpreted along with corresponding results on Hospital reference values were 0 – 4.7 U/l for ACP and prostate cancer patients. Furthermore, a similar PSA 0 – 1.7 U/l for PAP. We excluded PSA results of men who reduction cannot without reservation be equalled to had undergone prostate manipulation (cystoscopy, biopsy similar effectiveness against prostate cancer. The fall in or pressure flow examination) less than 14 days prior to PSA may represent a direct result of a decline in tumour blood sampling and ACP and PAP results of men who volume, but may also reflect a change in protein binding had undergone prostate manipulation less than three or cellular production of PSA, independently of the days prior to blood sampling. tumour burden, reflecting a biological effect of the agent on PSA production or excretion. Most men receiving hormones as primary treatment of Statistics prostate cancer have a substantial PSA elevation, and the The changes in PSA, ACP or PAP for patients receiving overwhelming reason for the subsequent PSA decline is bicalutamide or leuprolide were compared with changes the hormonal effect on prostate cancer tissue. However, in the corresponding placebo groups. The absolute values following the introduction of less toxic hormonal treat- of PSA and change in PSA were skewed with a right-hand ment regimens for prostate cancer, more patients with tail, whereas percentage change in PSA and absolute moderately elevated PSA and small cancers might be change in ACP and PAP had a symmetrical distribution. treated, in whom a substantial part of the PSA response Non-parametric (median, quartiles, Mann – Whitney test will be due to the effect of androgen suppression on PSA 5 for comparison of two groups and Wilcoxon test for from benign prostatic tissue. Data from the present study matched pairs) and parametric statistics (t-tests) were will help predict the degree of PSA decline that can be used. A P-value of < 0.05 was required for considering expected for these patients. a difference statistically significant. To the best of our knowledge, data on the effect of bicalutamide on PSA in BPH patients have not been published earlier, and there are limited data on the exact effect of LHRH agonists.6–8 The more unspecific prostate cancer markers ACP and PAP presently play a Results minimal role in the diagnosis and monitoring of prostate Prostate-specific antigen cancer, but are included in this report because there are conflicting reports as to how they are influenced by Baseline patient characteristics and reasons for exclusion androgen deprivation.7,9 are summarised in Tables 1 and 2. For patients receiving bicalutamide median per cent PSA decrease was 47% (interquartiles 34 – 69%) after 12 weeks (P < 0.001) and 56% (interquartiles 31 – 71%) after 24 weeks (P < 0.001). Patients and methods At week 48 PSA had returned to baseline (Figure 1). There was no statistically significant change in PSA for placebo Both studies were approved by the local ethical commit- patients. Two out of 11 patients had a PSA decrease of tee. Study participants were recruited from August 1989 80% or more, but none had a PSA decrease of 90% or to June 1991 among consecutive patients being referred more after 3 months. for assessment of BPH at our out-patient clinic. Following informed consent, and depending on time of entry, they were entered into the leuprolide study or the bicalutamide Table 1 Baseline patient characteristics in the bicalutamide study* study and randomised in a double-blind fashion to receive either placebo or active drug.10,11 Basically, the same Bicalutamide Placebo protocol was used for both studies. Main inclusion criteria No of patients randomised 15 15 were: symptoms of BPH prostate size larger that 30 ml by Mean patient age, y (s.d.) 68.5 (5.3) 66.1 (6.3) transrectal ultrasound planimetry, maximum urinary Mean prostate volume, ml (s.d.) 60.(27) 62.(25) flow rate of less than 12 ml per second and maximum No of men included in PSA analysis 11 12 Reason for exclusion from PSA analyses intravesical pressure greater than 70 cmH2O by pressure- flow examination. All men had four negative prostate Non-compliance 2 0 Cancer diagnosed after entry 0 1 biopsy cores prior to entry, taken from each side of the Missing baseline value 1 0 central part of the prostate by the perineal route. Blood sampling 14 days after In the bicalutamide study the patients received 50 mg prostate manipulation 1 2 once daily orally of the nonsteroidal antiandrogen bica- Median (range) serum PSA (ng/ml) 3.4 (1.3 – 13.1) 3.0 (0.6 – 7.2) lutamide or placebo. In the leuprolide study they received No of men included in ACP/PAP 14 13 intramuscular injection every 28 days of 3.75 mg of the analysis LHRH agonist leuprolide depot or matched placebo *No statistically significant differences between groups. Prostate Cancer and Prostatic Diseases Effects of bicalutamide and leuprolide LM Eri & KJ Tveter 175 Table 2 Baseline patient characteristics in the leuprolide study* Leuprolide Placebo No of patients randomised 28 27 Mean patient age, y (s.d.) 70.1 Æ 5.4 72.2 Æ 6.2 Mean prostate volume, ml (s.d.) 58 (19) 57 (32) No of men included in PSA analysis 14 18 Reason for exclusion from PSA analyses Non-compliance 3 2 Cancer diagnosed after entry 2 1 Missing baseline value 2 3 Blood sampling 14 days after 73 prostate manipulation Median (range) serum PSA (ng/ml) 3.3 (1.1 – 21.0) 2.7 (0.5 – 16.0) No of men included in ACP/PAP 25 24 analysis *No statistically significant differences between groups. For patients receiving leuprolide median per cent decrease in PSA was 83% (interquartiles 65 to 88%) after 12 weeks (P < 0.001). From week 12 to week 24 PSA continued to decrease (P ¼ 0.003), and per cent PSA decrease reached a median of 87% (interquartiles 82 – 94%) compared to baseline (Figure 1).
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