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Association of androgen-deprivation therapy with excess cardiac-specific mortality in men with prostate cancer.
Ziehr DR, Chen MH, Zhang D, Braccioforte MH, Moran BJ, Mahal BA, Hyatt AS, Basaria SS, Beard CJ, Beckman JA, Choueiri TK, D'Amico AV, Hoffman KE, Hu JC, Martin NE, Sweeney CJ, Trinh QD, Nguyen PL
(2015) BJU Int 116: 358-65
MeSH Terms: Aged, Aged, 80 and over, Androgen Antagonists, Antineoplastic Agents, Hormonal, Coronary Disease, Goserelin, Humans, Leuprolide, Male, Middle Aged, Prostatic Neoplasms, Retrospective Studies, Risk Factors
Show Abstract · Added January 15, 2016
OBJECTIVES - To determine if androgen-deprivation therapy (ADT) is associated with excess cardiac-specific mortality (CSM) in men with prostate cancer and no cardiovascular comorbidity, coronary artery disease risk factors, or congestive heart failure (CHF) or past myocardial infarction (MI).
PATIENTS AND METHODS - In all, 5077 men (median age 69.5 years) with cT1c-T3N0M0 prostate cancer were treated with brachytherapy with or without neoadjuvant ADT (median duration 4 months) between 1997 and 2006. Fine and Gray competing risks analysis evaluated the association of ADT with CSM, adjusting for age, year of brachytherapy, and ADT treatment propensity score among men in groups defined by cardiac comorbidity.
RESULTS - After a median follow-up of 4.8 years, no association was detected between ADT and CSM in men with no cardiac risk factors (1.08% at 5 years for ADT vs 1.27% at 5 years for no ADT, adjusted hazard ratio (AHR) 0.83; 95% confidence interval (CI), 0.39-1.78; P = 0.64; n = 2653) or in men with diabetes mellitus, hypertension, or hypercholesterolaemia (2.09% vs 1.97%, AHR 1.33; 95% CI 0.70-2.53; P = 0.39; n = 2168). However, ADT was associated with significantly increased CSM in men with CHF or MI (AHR 3.28; 95% CI 1.01-10.64; P = 0.048; n = 256). In this subgroup, the 5-year cumulative incidence of CSM was 7.01% (95% CI 2.82-13.82%) for ADT vs 2.01% (95% CI 0.38-6.45%) for no ADT.
CONCLUSION - ADT was associated with a 5% absolute excess risk of CSM at 5 years in men with CHF or prior MI, suggesting that administering ADT to 20 men in this potentially vulnerable subgroup could result in one cardiac death.
© 2014 The Authors. BJU International © 2014 BJU International Published by John Wiley & Sons Ltd.
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13 MeSH Terms
Quality of life after sipuleucel-T therapy: results from a randomized, double-blind study in patients with androgen-dependent prostate cancer.
Beer TM, Schellhammer PF, Corman JM, Glodé LM, Hall SJ, Whitmore JB, Frohlich MW, Penson DF
(2013) Urology 82: 410-5
MeSH Terms: Aged, Androgen Antagonists, Antineoplastic Combined Chemotherapy Protocols, Cancer Vaccines, Double-Blind Method, Fatigue, Gonadotropin-Releasing Hormone, Hot Flashes, Humans, Male, Middle Aged, Prostatic Neoplasms, Quality of Life, Sexual Dysfunction, Physiological, Surveys and Questionnaires, Sweating, Tissue Extracts
Show Abstract · Added March 7, 2014
OBJECTIVE - To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer.
METHODS - Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list.
RESULTS - One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80% power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2% of sipuleucel-T-treated patients and 21.6% of control-treated patients (P = .68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P = .88). Results were comparable for usual fatigue (P = .91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P = .26). The proportion of patients reporting better overall QOL on GRoC was similar (P = .62).
CONCLUSION - There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.
Copyright © 2013 Elsevier Inc. All rights reserved.
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17 MeSH Terms
Efficacy of intermittent androgen deprivation therapy vs conventional continuous androgen deprivation therapy for advanced prostate cancer: a meta-analysis.
Tsai HT, Penson DF, Makambi KH, Lynch JH, Van Den Eeden SK, Potosky AL
(2013) Urology 82: 327-33
MeSH Terms: Androgen Antagonists, Confidence Intervals, Disease Progression, Gonadotropin-Releasing Hormone, Humans, Male, Odds Ratio, Prostatic Neoplasms, Randomized Controlled Trials as Topic, Survival Analysis
Show Abstract · Added March 7, 2014
OBJECTIVE - To compare the efficacy of intermittent androgen deprivation therapy (IADT) vs continuous androgen deprivation therapy (CADT) for the treatment of advanced prostate cancer; we performed a meta-analysis of randomized controlled trials (RCTs), assessing the risks of disease progression, all-cause, and disease-specific mortality.
MATERIALS AND METHODS - We conducted a systematic search of several bibliographic systems to identify all RCTs of IADT in men with newly diagnosed metastatic or biochemical only prostate cancer. We abstracted outcome data, study characteristics, and participant demographics. We performed heterogeneity tests and calculated the summarized risk differences (RD) and risk ratios at 95% confidence intervals (CI), using inverse variance methods in random-effects approaches.
RESULTS - We identified 8 RCTs (N = 4664) comparing mortality between IADT and CADT. For all men combined, we observed small but nonsignificant differences in all-cause mortality (RD = 0.02, 95% CI = -0.02, 0.06), disease-specific mortality (RD = 0.04, 95% CI = -0.01, 0.08), and disease progression (RD = -0.03, 95% CI = -0.09, 0.04). Among the prespecified subgroup with histologically confirmed, newly diagnosed metastatic disease, we found no difference in overall survival (RD = 0.00, 95% CI = -0.09, 0.09).
CONCLUSION - We found no difference in overall survival, but a small increased risk in disease-specific survival for men treated with IADT relative to CADT was observed. IADT could be considered as an alternative to CADT because of better quality of life outcome. Patients should be informed of the possible risks and benefits of both therapies. More research confirming the benefits of IADT vs CADT is needed to inform treatment decisions.
Copyright © 2013 Elsevier Inc. All rights reserved.
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10 MeSH Terms
Capsule commentary on Shahinian et al.: Patterns of bone mineral density testing in men receiving androgen deprivation for prostate cancer.
Penson DF
(2013) J Gen Intern Med 28: 1494
MeSH Terms: Absorptiometry, Photon, Androgen Antagonists, Bone Density, Humans, Male, Prostatic Neoplasms, SEER Program
Added March 5, 2014
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7 MeSH Terms
Castration-resistant prostate cancer: AUA Guideline.
Cookson MS, Roth BJ, Dahm P, Engstrom C, Freedland SJ, Hussain M, Lin DW, Lowrance WT, Murad MH, Oh WK, Penson DF, Kibel AS
(2013) J Urol 190: 429-38
MeSH Terms: Androgen Antagonists, Antineoplastic Agents, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Drug Administration Schedule, Drug Resistance, Neoplasm, Glucocorticoids, Humans, Immunotherapy, Male, Prostatic Neoplasms
Show Abstract · Added March 7, 2014
PURPOSE - This Guideline is intended to provide a rational basis for the management of patients with castration-resistant prostate cancer based on currently available published data.
MATERIALS AND METHODS - A systematic review and meta-analysis of the published literature was conducted using controlled vocabulary supplemented with keywords relating to the relevant concepts of prostate cancer and castration resistance. The search strategy was developed and executed by reference librarians and methodologists to create an evidence report limited to English-language, published peer-reviewed literature. This review yielded 303 articles published from 1996 through 2013 that were used to form a majority of the guideline statements. Clinical Principles and Expert Opinions were used for guideline statements lacking sufficient evidence-based data.
RESULTS - Guideline statements were created to inform clinicians on the appropriate use of observation, androgen-deprivation and antiandrogen therapy, androgen synthesis inhibitors, immunotherapy, radionuclide therapy, systemic chemotherapy, palliative care and bone health. These were based on six index patients developed to represent the most common scenarios encountered in clinical practice.
CONCLUSIONS - As a direct result of the significant increase in FDA-approved therapeutic agents for use in patients with metastatic CRPC, clinicians are challenged with a multitude of treatment options and potential sequencing of these agents that, consequently, make clinical decision-making more complex. Given the rapidly evolving nature of this field, this guideline should be used in conjunction with recent systematic literature reviews and an understanding of the individual patient's treatment goals. In all cases, patients' preferences and personal goals should be considered when choosing management strategies.
Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.
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11 MeSH Terms
Urological cancer: walking the tightrope of survival and quality of life with ADT.
Resnick MJ
(2013) Nat Rev Clin Oncol 10: 307-8
MeSH Terms: Androgen Antagonists, Anilides, Gonadotropin-Releasing Hormone, Goserelin, Humans, Male, Nitriles, Prostatic Neoplasms, Quality of Life, Tosyl Compounds
Added March 7, 2014
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10 MeSH Terms
Quality of life with advanced metastatic prostate cancer.
Resnick MJ, Penson DF
(2012) Urol Clin North Am 39: 505-15
MeSH Terms: Androgen Antagonists, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Bone Neoplasms, Denosumab, Diphosphonates, Disease Progression, Docetaxel, Health Status Indicators, Humans, Imidazoles, Male, Mitoxantrone, Prostatic Neoplasms, Quality of Life, Taxoids, Treatment Outcome, Zoledronic Acid
Show Abstract · Added March 5, 2014
The health-related quality-of-life (HRQOL) implications of advanced metastatic prostate cancer are variable. There are several different HRQOL instruments that measure domains germane to patients with advanced metastatic disease. The burden of prostate cancer is inversely related to the magnitude of HRQOL declines. Treatment with androgen deprivation therapy commonly results in HRQOL declines that have served as the impetus for intermittent therapy. Conversely, chemotherapeutic agents have been associated with improvements in functional status for men with castrate-resistant disease. Emerging therapies may result in significant HRQOL improvements in this population, and careful prospective evaluation of patient-reported outcomes will be required.
Copyright © 2012 Elsevier Inc. All rights reserved.
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18 MeSH Terms
Phase I study of concurrent weekly docetaxel, high-dose intensity-modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) for high-risk prostate cancer.
Chen RC, Rosenman JG, Hoffman LG, Chiu WK, Wang AZ, Pruthi RS, Wallen EM, Crane JM, Kim WY, Rathmell WK, Godley PA, Whang YE
(2012) BJU Int 110: E721-6
MeSH Terms: Aged, Androgen Antagonists, Antineoplastic Agents, Disease-Free Survival, Docetaxel, Dose-Response Relationship, Drug, Follow-Up Studies, Gonadotropin-Releasing Hormone, Humans, Male, Middle Aged, Neoplasm Staging, Prospective Studies, Prostate-Specific Antigen, Prostatic Neoplasms, Radiation-Sensitizing Agents, Radiotherapy Dosage, Radiotherapy, Intensity-Modulated, Taxoids, Treatment Outcome
Show Abstract · Added October 17, 2015
UNLABELLED - Study Type - Therapy (phase 1) Level of Evidence 2a What's known on the subject? and What does the study add? High-risk and locally advanced prostate cancers are difficult to cure with the standard regimen of radiation therapy (RT) with concurrent androgen-deprivation therapy (ADT). Multiple studies have explored the addition of docetaxel chemotherapy in attempt to improve patient outcomes. Prior Phase I studies have shown that docetaxel 20 mg/m(2) is a safe dose, when given concurrently with 70 Gy of radiation. But current standard RT for prostate cancer uses higher doses, and it is unclear if concurrent chemotherapy is safe with modern RT. This is a Phase I study that explored the addition of concurrent docetaxel chemotherapy to modern RT (intensity-modulated RT to 78 Gy) plus ADT. The study showed that weekly docetaxel at 20 mg/m(2) is safe with modern RT. At a median follow-up of 2.2 years, biochemical progression-free survival was 94%. This triple-therapy regimen is safe and promising for further evaluation in prospective trials.
OBJECTIVE - •  To evaluate in a phase I trial, the feasibility of adding concurrent weekly docetaxel chemotherapy to high-dose intensity modulated radiation therapy (IMRT) and androgen-deprivation therapy (ADT) for treatment of high-risk prostate cancer.
PATIENTS AND METHODS - •  Patients with high-risk prostate cancer were treated with a luteinising hormone-releasing hormone agonist (starting 2-3 months before IMRT and lasting 2 years), IMRT of 78 Gy to the prostate and seminal vesicles, and weekly docetaxel during RT. •  All patients had computed tomography and bone scans to exclude metastatic disease. •  A standard 3 + 3 design was used for docetaxel dose escalation. Successive patients were treated on dose levels of 10, 15, and 20 mg/m(2) of weekly docetaxel.
RESULTS - •  In all, 18 patients participated in the study: 15 (83%) had Gleason 8-10 disease; the other three had either clinical T3 disease and/or a prostate-specific antigen (PSA) level of >20 ng/mL. •  Grade 3 diarrhoea (a defined dose-limiting toxicity, DLT) occurred in one patient in each of the first two dose levels. However, when the cohorts were expanded, no further DLT was seen. •  Weekly docetaxel at 20 mg/m(2) (dose level 3) was successfully given without DLT. •  No patient had grade 4 or 5 toxicity. •  At a median follow-up of 2.2 years, all patients achieved a PSA nadir of <1 ng/mL, including 13 patients who had an undetectable PSA level. The 2-year biochemical progression-free survival was 94%.
CONCLUSION - •  A dose of 20 mg/m(2) of weekly docetaxel given concurrently with high-dose IMRT and ADT appears safe for further study in patients with high-risk prostate cancer.
© 2012 BJU INTERNATIONAL.
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20 MeSH Terms
Factors associated with satisfaction with prostate cancer care: results from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE).
Resnick MJ, Guzzo TJ, Cowan JE, Knight SJ, Carroll PR, Penson DF
(2013) BJU Int 111: 213-20
MeSH Terms: Adult, Aged, Androgen Antagonists, Epidemiologic Methods, Fear, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Patient Acceptance of Health Care, Patient Satisfaction, Prostatectomy, Prostatic Neoplasms, Quality of Health Care, Quality of Life, Radiotherapy, Adjuvant, Sexual Dysfunction, Physiological, Socioeconomic Factors, United States
Show Abstract · Added March 5, 2014
OBJECTIVE - To evaluate the impact of demographic, clinical, treatment and patient-reported parameters on satisfaction with prostate cancer care. Despite the significant worldwide impact of prostate cancer, few data are available specifically addressing satisfaction with treatment-related care.
PATIENTS AND METHODS - CaPSURE comprises participants from 40 US sites who were monitored during and after their treatment course. Participants who were diagnosed with clinically localized prostate cancer after 1999 underwent radical prostatectomy, radiation therapy or primary androgen deprivation, and those who also completed the satisfaction questionnaire within 2 years of treatment were included in the present study. Satisfaction was measured using a validated instrument that assesses contact with providers, confidence in providers, communication skills, humanness and overall satisfaction. Multivariable linear regression analysis were performed to evaluate the independent relationships between demographic, clinical, treatment and patient-reported parameters and satisfaction.
RESULTS - Of the 3056 participants, 1927 (63%) were treated with radical prostatectomy, 843 (28%) were treated with radiation therapy and 286 (9%) were treated with primary androgen deprivation. Multivariable analysis showed that multiple patient-reported factors were independently associated with satisfaction, whereas clinical, demographic and treatment parameters were not. Baseline health-related quality of life, measured by the 36-item short-form health survey, baseline fear of cancer recurrence (all P < 0.01) and declines in the sexual (P = 0.03), urinary (P < 0.01) and bowel (P = 0.02) function domains of the University of California Los Angeles Prostate Cancer Index were all independently associated with satisfaction. Patient-reported outcomes were more strongly associated with satisfaction in the low-risk subgroup.
CONCLUSIONS - Patient-reported factors such as health-related quality of life and fear of cancer recurrence are independently associated with satisfaction with care. Pretreatment parameters should be used to identify populations at-risk for dissatisfaction to allow for intervention and/or incorporation into treatment decision-making.
© 2012 The Authors. BJU International © 2012 BJU International.
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19 MeSH Terms
Androgen hormone action in prostatic carcinogenesis: stromal androgen receptors mediate prostate cancer progression, malignant transformation and metastasis.
Ricke EA, Williams K, Lee YF, Couto S, Wang Y, Hayward SW, Cunha GR, Ricke WA
(2012) Carcinogenesis 33: 1391-8
MeSH Terms: Androgen Antagonists, Androgens, Animals, Cell Transformation, Neoplastic, Disease Progression, Immunohistochemistry, Male, Mice, Neoplasm Metastasis, Prostatic Neoplasms, Receptors, Androgen, Reverse Transcriptase Polymerase Chain Reaction
Show Abstract · Added May 27, 2014
It has been postulated that prostatic carcinogenesis is androgen dependent and that androgens mediate their effects primarily through epithelial cells; however, definitive proof of androgen hormone action in prostate cancer (PRCA) progression is lacking. Here we demonstrate through genetic loss of function experiments that PRCA progression is androgen dependent and that androgen dependency occurs via prostatic stromal androgen receptors (AR) but not epithelial AR. Utilizing tissue recombination models of prostatic carcinogenesis, loss of AR function was evaluated by surgical castration or genetic deletion. Loss of AR function prevented prostatic carcinogenesis, malignant transformation and metastasis. Tissue-specific evaluation of androgen hormone action demonstrated that epithelial AR was not necessary for PRCA progression, whereas stromal AR was essential for PRCA progression, malignant transformation and metastasis. Stromal AR was not necessary for prostatic maintenance, suggesting that the lack of cancer progression due to stromal AR deletion was not related to altered prostatic homeostasis. Gene expression analysis identified numerous androgen-regulated stromal factors. Four candidate stromal AR-regulated genes were secreted growth factors: fibroblast growth factors-2, -7, -10 and hepatocyte growth factor which were significantly affected by androgens and anti-androgens in stromal cells grown in vitro. These data support the concept that androgens are necessary for PRCA progression and that the androgen-regulated stromal microenvironment is essential to carcinogenesis, malignant transformation and metastasis and may serve as a potential target in the prevention of PRCA.
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12 MeSH Terms