Bicalutamide 50 mg monotherapy in patients with isolated high-grade PIN: findings in repeat biopsies at 6 months

Bono, Aldo; Mazzucchelli, Roberta; Ferrari, Ilaria; López-Beltrán, Antonio; Galosi, Andrea Benedetto; Liu, Cheng; Montironi, Rodolfo

doi:10.1136/jcp.2006.040311

Cited by 16 publications

(12 citation statements)

References 27 publications

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“…In relation to doxazosinum, the remission's results might prove that the positive influence on PIN, especially in relation to HG PIN. If, as claim Bono et al, the HG PIN remission might also exist independently (without treatment) in as many as 13% of patients, the positive influence would be objectively visible (27.3%) but moderate [22]. For Finasteride, the results seem to confirm the data from PPc metaanalysis, where the decrease in percentage of HG PIN by 21% was shown [21].…”

Section: Discussionsupporting

confidence: 80%

“…It is possible that an almost 19-month period (on average) of observation is not enough to reveal the discussed dependence, as well as an insufficient number of patients did not allow for an evaluation of statistically strong connections between considered factors. Part of these concerns might have been answered by adding and assessing a placebo group [22]. However, in the experimental environment, this is hard to conduct not only due to ethical concerns.…”

Section: Discussionmentioning

confidence: 99%

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The Impact of 5-Alpha Reductase Inhibitor vs. Alpha-1 Adrenergic Receptor Antagonists on Course of Prostate Premalignant Conditions

Fryczkowski¹,

Bryniarski²,

Szczębara³

et al. 2014

Adv Clin Exp Med

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Background. Prostate intraepithelial neoplasm and atypical small acinar proliferation are considered prostate premalignant conditions. Such a diagnosis impacts further follow-up significantly as early detection of prostate cancer is of utmost importance. alpha-1 adrenergic receptor antagonists (i.e. doxazosiunum) and inhibitors of 5-alpha reductase (Finasteride) showed some efficacy in prevention of prostate cancer development. Objectives. To assess the impact of both abovementioned drugs on prostate premalignant conditions. Material and Methods. From January 2008 till September 2012, 213 patients with one of the abovementioned premalignant condition were retrospectively evaluated. after diagnosis they were assigned to group 1 (n-126)-treated with Finasteride or to group 2 (n-87)-treated with doxazosinum. every 6-7 months rebiopsies were conducted in each patient. Rate of remission and progression was assessed. Results. In comparison between group 1 and 2 the rate of remission was 35.7% (n-45) vs. 18.4% (n-16) (p = 0.005). In terms of progression, the difference between 1st and 2nd group of patients was 7.1% (n-9) vs. 5.7% (n-5) (p = 0.68). Conclusions. Remission of prostate premalignant condition is efficacious with Finasteride and not with doxazosinum. However, in terms of progression there were no differences among both drugs (Adv Clin Exp Med 2014, 23, 1, 79-84).

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Section: Discussionsupporting

confidence: 80%

Section: Discussionmentioning

confidence: 99%

The Impact of 5-Alpha Reductase Inhibitor vs. Alpha-1 Adrenergic Receptor Antagonists on Course of Prostate Premalignant Conditions

Fryczkowski¹,

Bryniarski²,

Szczębara³

et al. 2014

Adv Clin Exp Med

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“…4 Antiandrogens are commonly used to treat isolated HGPIN, especially after the first cancer-negative biopsy and during the period when other biopsies are taken. Cyproterone acetate, 5 flutamide 6,7 and bicalutamide 8,9 reduce or delay the occurrence of PC in patients with isolated HGPIN.…”

Section: Introductionmentioning

confidence: 99%

Effects of castration on the development of prostate adenocarcinoma from its precursor HGPIN and on the occurrence of androgen-independent, poorly differentiated carcinoma in TRAMP mice

Bono¹,

Montironi

Pannellini

et al. 2008

Prostate Cancer Prostatic Dis

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Androgen ablation is thought to exert selective pressure for the development of androgenindependent forms of prostate cancer. This study was set up to investigate the effects of surgical castration on the development of prostate adenocarcinoma (ADC) from its precursor (high-grade prostate intraepithelial neoplasia (HGPIN)) and on the occurrence of androgen-independent, poorly differentiated carcinoma (PDC) in (C57Bl/6 transgenic adenocarcinoma of mouse prostate) TRAMP mice. It was found that castration cures HGPIN and ADC and prevents their further occurrence and growth, but has no effect on PDC. This indicates that in this model, PDC is not the progression of ADC favoured by androgen ablation and that its initiating cells are different from those of HGPIN and ADC.

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“…A trend toward a reduction of prostate cancer prevalence with bicalutamide versus no treatment (13% versus 22%) was also observed in our study, especially considering subjects with HG-PIN at baseline (13% versus 50%). We did not collect data on changes in prostate volume, which is known to be reduced by bicalutamide at the dose of 50 mg/d (22). Because prostate volume shrinkage under antiandrogen manipulation increases the likelihood of detecting prostate cancer or HG-PIN on end-ofstudy biopsy (7), the effect of weekly bicalutamide in treated subjects could even be underestimated in our study.…”

Section: Discussionmentioning

confidence: 99%

“…Differently from finasteride, bicalutamide directly interacts with the androgen receptor, thereby neutralizing the potentially detrimental testosterone surge that is observed during treatment. Moreover, at the daily dose of 50 to 150 mg, bicalutamide was found to decrease the incidence and extent of HG-PIN in pilot trials (22,23), thus predicting a beneficial modulation of prostate carcinogenesis in at-risk subjects. Finally, its pharmacodynamic and pharmacokinetic properties (9, 10) justified a once-a-week administration with 50 to 100 mg in an attempt to retain activity while substantially reducing toxicity.…”

Section: Discussionmentioning

confidence: 99%

Phase I-II Trial of Weekly Bicalutamide in Men with Elevated Prostate-Specific Antigen and Negative Prostate Biopsies

Zanardi

Puntoni

Maffezzini

et al. 2009

Cancer Prevention Research

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Background: Men with elevated prostate-specific antigen (PSA) and negative prostate biopsies are at risk for prostate cancer. The antiandrogen bicalutamide has a prolonged half-life, thus potentially allowing an intermittent administration to retain activity while reducing toxicity. We conducted a phase I-II trial of weekly bicalutamide in men with PSA >4 ng/mL and negative biopsies.Methods: Eighty subjects were nonrandomly assigned to a three-arm trial to either bicalutamide 50 mg/wk (n = 26) or 100 mg/wk (n = 28) or no treatment (n = 26) for 6 months. Blood samples were obtained at 0, 3, and 6 months, and prostate biopsies were repeated after 6 months. The outcome measures were 6-month changes of tissue Ki-67 (primary end point), high-grade prostatic intraepithelial neoplasia (HG-PIN), proliferative inflammatory atrophy, circulating PSA, and sex hormones.Results: Ki-67 expression was higher in HG-PIN than in normal tissue (10% versus 3%; P < 0.01) but was not modulated by bicalutamide in normal luminal cells. A trend toward an improvement of HG-PIN status was found in treated subjects (26% improved, 60% had no change, 15% worsened) as compared with the no-treatment arm (4% improved, 83% had no change, 13% worsened; P = 0.07). Proliferative inflammatory atrophy prevalence was not reduced by bicalutamide. Bicalutamide reduced PSA by 50% in both arms and raised testosterone and estradiol levels. Asymptomatic breast swelling was noted in 40% of the treated cases.Conclusions: A weekly administration of bicalutamide seems to be reasonably safe and shows an encouraging signal of activity on HG-PIN prevalence, supporting further studies of this schedule in men at high risk despite the negative primary end-point findings on Ki-67.

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Bicalutamide 50 mg monotherapy in patients with isolated high-grade PIN: findings in repeat biopsies at 6 months

Abstract: There was a lower incidence of HGPIN (treated group vs control: 10% vs 27.2%) after 6 months of bicalutamide. Reduction in its extent was also observed (treated group vs control: monofocal 100% vs 50%). Treatment did not affect the incidence of cancer (treated vs control: 5% vs 4.5%).

Cited by 16 publications

References 27 publications

The Impact of 5-Alpha Reductase Inhibitor vs. Alpha-1 Adrenergic Receptor Antagonists on Course of Prostate Premalignant Conditions

The Impact of 5-Alpha Reductase Inhibitor vs. Alpha-1 Adrenergic Receptor Antagonists on Course of Prostate Premalignant Conditions

Effects of castration on the development of prostate adenocarcinoma from its precursor HGPIN and on the occurrence of androgen-independent, poorly differentiated carcinoma in TRAMP mice

Phase I-II Trial of Weekly Bicalutamide in Men with Elevated Prostate-Specific Antigen and Negative Prostate Biopsies

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