Is there a role for antiandrogen monotherapy in patients with metastatic prostate cancer?

Kaisary, Amir; Iversen, Peter; Cj, Tyrrell; Carroll, Kevin; Morris, Thomas

doi:10.1038/sj.pcan.4500531

Cited by 38 publications

(14 citation statements)

References 41 publications

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“…Patients with metastatic (M1) prostate cancer receiving bicalutamide 150 mg monotherapy were also reported to have better quality‐of‐life scores, for maintenance of physical capacity and sexual interest, than patients receiving castration [10]. Although castration provided a significantly greater survival benefit (median survival extended by 6 weeks) than bicalutamide 150 mg in that study, subsequent exploratory analyses suggested that survival rates were similar among those patients with baseline PSA levels of ≤ 400 ng/mL [11].…”

Section: Introductionmentioning

confidence: 99%

Tolerability, efficacy and pharmacokinetics of bicalutamide 300 mg, 450 mg or 600 mg as monotherapy for patients with locally advanced or metastatic prostate cancer, compared with castration

et al. 2006

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OBJECTIVE To evaluate the pharmacokinetics, tolerability and effect on endocrinology of bicalutamide given as once‐daily monotherapy at doses of >150 mg to patients with locally advanced (M0) or metastatic (M1) prostate cancer, with efficacy as a secondary endpoint. PATIENTS AND METHODS Patients were initially enrolled to receive bicalutamide 300 mg in a non‐randomized phase, after which further patients were randomized to higher bicalutamide doses (in 150 mg increments) or castration. Overall, 248 patients received bicalutamide at 300 mg (21), 450 mg (95) or 600 mg (42), or castration (90). RESULTS Systemic exposure to bicalutamide stabilised at a dose of ≈ 300 mg, as determined by pharmacokinetic analysis. The tolerability of high doses of bicalutamide was similar to that of the 150 mg dose, with no increase in the incidence of adverse events. Patients receiving bicalutamide had early increases in the mean levels of oestradiol, testosterone and luteinizing hormone, which were maintained throughout the study. Levels of these hormones rapidly decreased in the castration group and remained low. From baseline (first day of treatment) to 12 weeks there was an equivalent reduction in prostate‐specific antigen (PSA) levels across all four groups. At a median follow‐up of 5 years, there was no significant survival difference between patients who received bicalutamide and those who received castration, either in M0 or M1 disease. CONCLUSION The low median PSA level (180 ng/mL) of patients with M1 disease might account for the lack of survival difference between the treatment groups. Further studies are needed to assess whether high‐dose bicalutamide monotherapy can provide equivalent efficacy to castration in patients with M1 prostate cancer.

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Section: Introductionmentioning

confidence: 99%

Tolerability, efficacy and pharmacokinetics of bicalutamide 300 mg, 450 mg or 600 mg as monotherapy for patients with locally advanced or metastatic prostate cancer, compared with castration

et al. 2006

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“…The use of antiandrogens remains the limitation of initial increase of testosterone (flare phenomenon) under treatment with LHRH analogues. Alternatively, they can also be used as monotherapy, especially in patients with marginal metastatic load with consideration of a better quality of life but only slightly shorter progression-free and overall survival in comparison to castration [4]. …”

Section: Introductionmentioning

confidence: 99%

Subcapsular Orchiectomy in the Primary Therapy of Patients with Bone Metastasis in Advanced Prostate Cancer: An Anachronistic Intervention?

Rud

Peter

Kheyri

et al. 2012

Advances in Urology

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Background. The therapeutic impact of palliative androgen deprivation in metastatic prostate cancer is indisputable. Bilateral orchiectomy represents the traditional method of AD but was reduced during the last years in favor for treatment with LHRH analogues. Due to limited economic resources of the health care system, the economically priced definite surgical castration might experience a renaissance. Methods. In this single-center retrospective study, 83 consecutive patients with osseous metastasized prostate cancer were evaluated, who had primarily been treated by subcapsular bilateral orchiectomy. Response to therapy, time until therapy failure, overall survival time, psychological disorders due to loss of organ, and disease-associated and postoperative surgical complications were recorded. The median followup was 35 months (IQR: 26–46). Results. Patients' mean age at surgery was 72.1 (54–91) years. Six patients (7.2%) displayed immediate tumor progression after orchiectomy. Median time of tumor remission and overall survival time were 29 and 36 months, respectively. 14% of the study group showed minor postoperative complications. No psychological problems occurred following bilateral orchiectomy. Conclusion. Due to an effective and persistent oncological effectiveness, less morbidity, and absence of psychological implications, bilateral subcapsular orchiectomy seems to be a practicable and advisable alternative in the first-line therapy of metastasized PCa.

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“…In patients with metastatic disease (n = 805), at a median follow-up of 1.9 years, bicalutamide 150 mg was not as effective as castration, although the difference in median survival was only 42 days [139]. Post hoc analysis of these results revealed that bicalutamide and castration had similar efficacy in patients with a pre-treatment PSA level of ≤400 ng/ml, while survival data only favored castration in patients with the highest tumour burdens at study entry (PSA >400 ng/ml) [140]. In patients with non-metastatic disease, at a median follow-up of 6.3 years, bicalutamide 150 mg was as effective as traditional hormonal therapy, with no statistically significant differences between treatment groups in terms of overall survival or time to disease progression [138].…”

Section: Bicalutamidementioning

confidence: 41%

Treatment of PSA only Recurrence of Prostate Cancer After Prior Local Therapy

Moul

2006

CPD

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Prostate cancer recurrence (after prior local treatment) that is detectable only by a rise in serum prostate specific antigen (PSA) level is a very common problem facing clinicians. Given that the majority of contemporary era men with PSA-only or biochemical recurrence are relatively young and otherwise healthy, treatment requires approaches that both improve clinical outcomes and preserve quality of life. Treatment is in one of two broad categories, additional local therapies, termed "salvage" local therapy and systemic therapies. For radical prostatectomy patients, salvage external beam radiotherapy to the prostate bed is commonly employed, being reserved for early biochemical recurrence in men with low risk at distant metastases. For primary radiation patients, salvage radical prostatectomy or cryotherapy can similarly be used for those men felt not to harbor distant metastases. Systemic therapy generally involves hormonal therapy. Traditional hormonal therapy (orchiectomy, luteinizing hormone-releasing hormone agonists or maximum androgen blockade) is the current mainstay of systemic treatment for biochemical recurrence, although non-traditional approaches, such as antiandrogen monotherapy, are increasingly being used. There is a critical need for new pharmaceutical agents to treat this growing stage of prostate cancer. However, it has been difficult to demonstrate efficacy due to the long natural history until death and the survival endpoint currently required by the U.S. Food and Drug Administration. New data show that PSA Doubling time (PSA-DT) during PSA recurrence may be a valid surrogate for death from the disease and may be used to accelerate drug approval. This monograph will attempt to provide a complete balanced discussion of the evaluation and treatment of biochemical recurrence of prostate cancer after prior primary local therapy.

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Is there a role for antiandrogen monotherapy in patients with metastatic prostate cancer?

Cited by 38 publications

References 41 publications

Tolerability, efficacy and pharmacokinetics of bicalutamide 300 mg, 450 mg or 600 mg as monotherapy for patients with locally advanced or metastatic prostate cancer, compared with castration

Tolerability, efficacy and pharmacokinetics of bicalutamide 300 mg, 450 mg or 600 mg as monotherapy for patients with locally advanced or metastatic prostate cancer, compared with castration

Subcapsular Orchiectomy in the Primary Therapy of Patients with Bone Metastasis in Advanced Prostate Cancer: An Anachronistic Intervention?

Treatment of PSA only Recurrence of Prostate Cancer After Prior Local Therapy

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