American Society of Clinical Oncology recommendations for the initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer.

PURPOSE To develop a clinical practice guideline for the management of men with metastatic, recurrent, or progressive carcinoma of the prostate. The focus of this document is on the use, combinations, and timing of various forms of androgen deprivation therapy (ADT) for the palliation of men with androgen-sensitive disease. METHODS An expert panel and writing committee were formed. The questions to be addressed by the guideline were determined, and a systematic review of the literature was performed, which included a search of online databases, bibliographic review, and consultation with content experts. A priori criteria were used to select studies for analysis and study authors were contacted when necessary. RESULTS There were 10 randomized controlled trials, six systematic reviews, and one Markov model available to inform the guidelines. CONCLUSION A full discussion between practitioner and patient should occur to determine which therapy is best for the patient. Bilateral orchiectomy or luteinizing hormone releasing hormone agonists are the recommended initial treatments. Nonsteroidal antiandrogen therapy may be discussed as an alternative, but steroidal antiandrogens should not be offered as monotherapy. Patients willing to accept the increased toxicity of combined androgen blockage for a small benefit in survival should be offered nonsteroidal antiandrogen in addition to castrate therapy. Until data from studies using modern medical diagnostic/biochemical tests and standardized follow-up schedules become available, no specific recommendations can be issued regarding the question of early versus deferred ADT. A discussion about the pros and cons of early versus deferred ADT should occur.

[1]  P. Walsh,et al.  Expectant management of nonpalpable prostate cancer with curative intent: preliminary results. , 2002, The Journal of urology.

[2]  D. Byar,et al.  Reconsideration of orchiectomy in the treatment of advanced prostatic carcinoma. , 1977, Southern medical journal.

[3]  M. Wirth,et al.  Bicalutamide (Casodex) 150 mg as immediate therapy in patients with localized or locally advanced prostate cancer significantly reduces the risk of disease progression. , 2001, Urology.

[4]  K. Pienta,et al.  The Current State of Hormonal Therapy for Prostate Cancer , 2002, CA: a cancer journal for clinicians.

[5]  B. Parys,et al.  Severe hepatocellular dysfunction following cyproterone acetate therapy. , 1991, British journal of urology.

[6]  R. A. Jones,et al.  Immediate versus deferred treatment for advanced prostatic cancer: initial results of the Medical Research Council Trial. The Medical Research Council Prostate Cancer Working Party Investigators Group. , 1997, British journal of urology.

[7]  L. Klotz,et al.  Expectant management with selective delayed intervention for favorable-risk prostate cancer. , 2002, The Canadian journal of urology.

[8]  D. Byar,et al.  Estrogen treatment for cancer of the prostate. Early results with 3 doses of diethylstilbestrol and placebo , 1970, Cancer.

[9]  Crawford,et al.  Maximum androgen blockade in advanced prostate cancer: an overview of the randomised trials , 2000, The Lancet.

[10]  L. Klotz,et al.  A phase 1-2 trial of diethylstilbestrol plus low dose warfarin in advanced prostate carcinoma. , 1999, The Journal of urology.

[11]  V. Hasselblad,et al.  Systematic review and meta‐analysis of monotherapy compared with combined androgen blockade for patients with advanced prostate carcinoma , 2002, Cancer.

[12]  R. Fine,et al.  Induction of apoptosis by diethylstilbestrol in hormone-insensitive prostate cancer cells. , 1996, Journal of the National Cancer Institute.

[13]  J. Moul Variables in predicting survival based on treating "PSA-only" relapse. , 2003, Urologic oncology.

[14]  L. Lenormand,et al.  Intermittent Androgen Suppression in the Treatment of Metastatic Prostate Cancer , 2000, European Urology.

[15]  P. Kantoff,et al.  Pamidronate to prevent bone loss during androgen-deprivation therapy for prostate cancer. , 2001, The New England journal of medicine.

[16]  M. Parmar,et al.  Meta-analysis of the literature or of individual patient data: is there a difference? , 1993, The Lancet.

[17]  W. Ellis,et al.  Intermittent androgen suppression with leuprolide and flutamide for prostate cancer: a pilot study. , 1996, Urology.

[18]  C. Roehrborn,et al.  Prospective determination of the hormonal response after cessation of luteinizing hormone-releasing hormone agonist treatment in patients with prostate cancer. , 1999, Urology.

[19]  P. Carroll,et al.  Intermittent androgen deprivation: update of cycling characteristics in patients without clinically apparent metastatic prostate cancer. , 2001, Urology.

[20]  Adalsteinn D. Brown,et al.  Cost-effectiveness of androgen suppression therapies in advanced prostate cancer. , 2000, Journal of the National Cancer Institute.

[21]  R. Sylvester,et al.  Comparison of diethylstilbestrol, cyproterone acetate and medroxyprogesterone acetate in the treatment of advanced prostatic cancer: final analysis of a randomized phase III trial of the European Organization for Research on Treatment of Cancer Urological Group. , 1986, The Journal of urology.

[22]  P. Iversen,et al.  Is there a role for antiandrogen monotherapy in patients with metastatic prostate cancer? , 2001, Prostate Cancer and Prostatic Diseases.

[23]  J. Gingell,et al.  A prospective, randomised study to compare goserelin acetate (Zoladex) versus cyproterone acetate (Cyprostat) versus a combination of the two in the treatment of metastatic prostatic carcinoma. , 1996, European urology.

[24]  D. Gleason,et al.  A phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer. , 2001, Urology.

[25]  W. Whitmore,et al.  Update in Staging Systems , 1987 .

[26]  D. Byar,et al.  Incidence of cardiovascular disease and death in patients receiving diethylstilbestrol for carcinoma of the prostate , 1970, Cancer.

[27]  Neil Fleshner,et al.  Feasibility study: watchful waiting for localized low to intermediate grade prostate carcinoma with selective delayed intervention based on prostate specific antigen, histological and/or clinical progression. , 2002, The Journal of urology.

[28]  I. Thompson,et al.  Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. , 1998, The New England journal of medicine.

[29]  Jacques P. Brown,et al.  2002 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada. , 2002, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[30]  E. Gelmann,et al.  Androgen blocks apoptosis of hormone-dependent prostate cancer cells. , 2001, Cancer research.

[31]  A W Partin,et al.  Natural history of progression after PSA elevation following radical prostatectomy. , 1999, JAMA.

[32]  J. Blasko,et al.  Pretreatment nomogram for predicting freedom from recurrence after permanent prostate brachytherapy in prostate cancer. , 2001, Urology.

[33]  P. Schellhammer,et al.  Patients' choice of treatment in stage D prostate cancer. , 1989, Urology.

[34]  T. Wilt,et al.  Combined androgen blockade with nonsteroidal antiandrogens for advanced prostate cancer: a systematic review. , 2001, Urology.

[35]  J. Manola,et al.  Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer. , 1999, The New England journal of medicine.

[36]  Jerome Seidenfeld,et al.  Single-Therapy Androgen Suppression in Men with Advanced Prostate Cancer , 2000, Annals of Internal Medicine.

[37]  John Trachtenberg,et al.  A phase 3, multicenter, open label, randomized study of abarelix versus leuprolide plus daily antiandrogen in men with prostate cancer. , 2002, The Journal of urology.

[38]  D. Byar The veterans administration cooperative urological research group's studies of cancer of the prostate , 1973, Cancer.

[39]  S. Ho,et al.  Clinical review 134: The endocrinology of prostate cancer. , 2001, The Journal of clinical endocrinology and metabolism.

[40]  L. Klotz,et al.  Intermittent endocrine therapy for advanced prostate cancer , 1986, Cancer.

[41]  M. Riggs,et al.  Stage at presentation and survival of white and black patients with prostate carcinoma , 1993, Cancer.

[42]  Pierre I Karakiewicz,et al.  International validation of a preoperative nomogram for prostate cancer recurrence after radical prostatectomy. , 2002, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[43]  G. Duncan,et al.  Watchful waiting or watchful progression? , 1998, Cancer.

[44]  T. Wilt,et al.  Early versus deferred androgen suppression in the treatment of advanced prostatic cancer. , 2001, The Cochrane database of systematic reviews.

[45]  D. Reese Choice of hormonal therapy for prostate cancer , 2000, The Lancet.

[46]  Mcleod,et al.  Tolerability of Nonsteroidal Antiandrogens in the Treatment of Advanced Prostate Cancer. , 1997, The oncologist.

[47]  W F Hendry,et al.  Importance of early tumour exacerbation in patients treated with long acting analogues of gonadotrophin releasing hormone for advanced prostatic cancer. , 1985, British medical journal.

[48]  D. Dearnaley,et al.  Recovery of serum testosterone, LH and FSH levels following neoadjuvant hormone cytoreduction and radical radiotherapy in localized prostate cancer. , 2001, Clinical oncology (Royal College of Radiologists (Great Britain)).

[49]  R. Sylvester,et al.  The final analysis of the EORTC Genito-Urinary Tract Cancer Co-Operative Group phase III clinical trial (protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate. , 1995, European urology.

[50]  A. Dicker The safety and tolerability of low-dose irradiation for the management of gynaecomastia caused by antiandrogen monotherapy. , 2003, The Lancet. Oncology.

[51]  G. Duncan,et al.  Watchful waiting or watchful progression? , 1998, Cancer.

[52]  D. Byar,et al.  Hormone therapy for prostate cancer: results of the Veterans Administration Cooperative Urological Research Group studies. , 1989, NCI monographs : a publication of the National Cancer Institute.