Prostatic Neoplasms: Sartor O

Arlen PM, Bianco F, Dahut WL, D'Amico A, Figg WD, Freedland SJ, Gulley JL, Kantoff PW, Kattan MW, Lee A, Regan MM, Sartor O, Anonymous00032. · Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland 20892, USA. · J Urol. · Pubmed #18423743 links to  free full text

Abstract: PURPOSE: Prostate specific antigen is a glycoprotein found almost exclusively in normal and neoplastic prostate cells. Prostate specific antigen doubling time, or the change in prostate specific antigen over time, has emerged as a useful predictive marker for assessing disease outcome in patients with prostate cancer. It is important to agree on definitions and values for the calculation of prostate specific antigen doubling time, and to develop a common approach to outcome analysis and reporting. MATERIALS AND METHODS: In September 2006 a conference was held at the National Cancer Institute in Bethesda, Maryland to define these parameters and develop guidelines for their use. RESULTS: The Prostate Specific Antigen Working Group defined criteria regarding prostate specific antigen doubling time including the calculation of prostate specific antigen doubling time, evidence to support prostate specific antigen doubling time as a predictive factor in the setting of biochemical recurrence and the use of prostate specific antigen doubling time as a stratification factor in clinical trials. CONCLUSIONS: We propose that investigators calculate prostate specific antigen doubling time before enrolling patients in clinical studies and calculate it as an additional measurement of therapeutic activity. We believe we have developed practical guidelines for the calculation of prostate specific antigen doubling time and its use as a measurement of prognosis and outcome. Furthermore, the use of common standards for prostate specific antigen doubling time in clinical trials is important as we determine which treatments should progress to randomized trials in which "hard" end points such as survival will be used.

Chang SS, Benson MC, Campbell SC, Crook J, Dreicer R, Evans CP, Hall MC, Higano C, Kelly WK, Sartor O, Smith JA, Anonymous00135. · Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee 37232, USA. · Cancer. · Pubmed #15558815 links to  free full text

Abstract: Because patients with hormone-refractory prostate carcinoma are a very diverse group, management of these patients represents a unique challenge. Despite much research, to the authors' knowledge few studies published to date have provided definitive treatment answers. The Society of Urologic Oncology (SUO) convened a multidisciplinary panel of urologists, oncologists, and radiation oncologists to develop a treatment algorithm for patients with hormone-refractory prostate carcinoma. The resulting treatment outline was based on a review of the literature review and on the expert opinions of the panelists. The current article provided a logical progression of treatment choices that included hormonal manipulations, chemotherapeutic options, and adjunctive therapies. Future clinical trials and therapies were also discussed by the authors. Management strategies should be targeted toward the individual patient. Although significant progress has been made in understanding and treating hormone-refractory prostate carcinoma, earlier interventions would be ideal and better therapeutic approaches to prolong survival are necessary.

Sartor O. · No affiliation provided · J Clin Oncol. · Pubmed #19364953 No free full text.

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Sartor O. · No affiliation provided · Clin Genitourin Cancer. · Pubmed #18824426 links to  free full text

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Sartor O. · No affiliation provided · Clin Genitourin Cancer. · Pubmed #18272022 No free full text.

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Sartor O. · No affiliation provided · Clin Genitourin Cancer. · Pubmed #17645826 No free full text.

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Sartor O, Alchalabi T, Figg WD. · No affiliation provided · Clin Genitourin Cancer. · Pubmed #17026796 No free full text.

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Sartor O, Loriaux DL. · No affiliation provided · Clin Genitourin Cancer. · Pubmed #16859573 No free full text.

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Sartor O. · No affiliation provided · Clin Genitourin Cancer. · Pubmed #16729904 No free full text.

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Sartor O, George D. · No affiliation provided · Clin Prostate Cancer. · Pubmed #15992455 No free full text.

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Sartor O. · No affiliation provided · Clin Prostate Cancer. · Pubmed #15882474 No free full text.

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Sartor O. · No affiliation provided · Clin Prostate Cancer. · Pubmed #15636677 No free full text.

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Sartor O. · No affiliation provided · Clin Prostate Cancer. · Pubmed #15479486 No free full text.

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Sartor O, Koochekpour S. · No affiliation provided · Clin Prostate Cancer. · Pubmed #15279683 No free full text.

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Sartor O. · No affiliation provided · Clin Prostate Cancer. · Pubmed #15072599 No free full text.

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Sartor O. · No affiliation provided · Clin Prostate Cancer. · Pubmed #15046674 No free full text.

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Sartor O. · No affiliation provided · Clin Prostate Cancer. · Pubmed #15040865 No free full text.

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Sartor O, McLeod D. · Stanley S. Scott Cancer Center and Department of Medicine, Louisiana State University Medical School, New Orleans, Louisiana 70112, USA . · Urology. · Pubmed #11248605 No free full text.

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Garmey EG, Sartor O, Halabi S, Vogelzang NJ. · Arqule Inc., Woburn, MA 01801-5140, USA. · Clin Adv Hematol Oncol. · Pubmed #18347563 No free full text.

Abstract: Prostate cancer is the most common cancer occurring among men in the United States. In spite of the disease's favorable prognosis, approximately 30,000 U.S. men develop incurable metastatic disease each year, making prostate cancer the second-leading cause of cancer-related deaths among men in the United States. Although hormone-based therapies generally result in rapid responses, virtually all patients ultimately develop androgen-independent progressive disease. It is among these men with hormone-refractory prostate cancer (HRPC) that the role of chemotherapy continues to be investigated. To date, three drugs (estramustine, mitoxantrone, and docetaxel) have been approved by the US Food and Drug Administration (FDA) for first-line chemotherapy in HRPC, with other agents and combinations now under evaluation in ongoing clinical trials. Patients whose tumors progress through first-line chemotherapy have limited treatment options available to them and less than half of all men with HRPC will receive any second-line chemotherapy. To date, only one phase III randomized clinical trial has been completed in this setting and no therapies are FDA-approved. We review here the entirety of phase II and III data evaluating chemotherapy agents in second-line HRPC.

Eggener SE, Scardino PT, Carroll PR, Zelefsky MJ, Sartor O, Hricak H, Wheeler TM, Fine SW, Trachtenberg J, Rubin MA, Ohori M, Kuroiwa K, Rossignol M, Abenhaim L, Anonymous00105. · No affiliation provided · J Urol. · Pubmed #17936815 No free full text.

Abstract: PURPOSE: Based on contemporary epidemiological and pathological characteristics of prostate cancer we explain the rationale for and concerns about focal therapy for low risk prostate cancer, review potential methods of delivery and propose study design parameters. MATERIALS AND METHODS: Articles regarding the epidemiology, diagnosis, imaging, treatment and pathology of localized prostate cancer were reviewed with a particular emphasis on technologies applicable for focal therapy, defined as targeted ablation of a limited area of the prostate expected to contain the dominant or only focus of cancer. A consensus summary was constructed by a multidisciplinary international task force of prostate cancer experts, forming the basis of the current review. RESULTS: In regions with a high prevalence of prostate specific antigen screening the over detection and subsequent overtreatment of prostate cancer is common. The incidence of unifocal cancers in radical prostatectomy specimens is 13% to 38%. In many others there is an index lesion with secondary foci containing pathological features similar to those found incidentally at autopsy. Because biopsy strategies and imaging techniques can provide more precise tumor localization and characterization, there is growing interest in focal therapy targeting unifocal or biologically unifocal tumors. The major arguments against focal therapy are multifocality, limited accuracy of staging, the unpredictable aggressiveness of secondary foci and the lack of established technology for focal ablation. Emerging technologies with the potential for focal therapy include high intensity focused ultrasound, cryotherapy, radio frequency ablation and photodynamic therapy. CONCLUSIONS: Early detection of prostate cancer has led to concerns that while many cancers now diagnosed pose too little a threat for radical therapy, many men are reluctant to accept watchful waiting or active surveillance. Several emerging technologies seem capable of focal destruction of prostate tissue with minimal morbidity. We encourage the investigation of focal therapy in select men with low risk prostate cancer in prospective clinical trials that carefully document safety, functional outcomes and cancer control.

Saad F, Higano CS, Sartor O, Colombel M, Murray R, Mason MD, Tubaro A, Schulman C. · Universite de Montreal, Quebec, Canada. · Clin Genitourin Cancer. · Pubmed #16729908 No free full text.

Abstract: In this study, we provide consensus guidelines for the use of bisphosphonates in men with prostate cancer. To this end, an expert panel composed of urologists, medical oncologists, radiation oncologists, and endocrinologists met to review current clinical evidence for the use of bisphosphonates in patients with different stages of prostate cancer to derive consensus recommendations. Physicians should be proactive in monitoring bone loss in patients receiving long-term androgen-deprivation therapy for prostate cancer. Further study is needed before recommending the routine use of bisphosphonates in men with nonmetastatic prostate cancer. However, if a patient has clinically significant bone loss, use of a bisphosphonate to prevent further compromise of bone integrity should be strongly considered, regardless of hormonal and metastatic status. Bone scans are the preferred method for the identification of bone metastases. In patients with hormone-refractory prostate cancer and bone metastases, zoledronic acid is the only bisphosphonate indicated for the prevention of skeletal complications. In conclusion, patients with prostate cancer are at high risk for skeletal morbidity. Bisphosphonates have been shown to prevent cancer treatment-induced bone loss in men receiving androgen-deprivation therapy as well as skeletal complications in men with bone metastases. However, further study of the use of bisphosphonates across the clinical spectrum of prostate cancer is needed.

McKoy JM, Lyons EA, Obadina E, Carson K, Pickard AS, Schellhammer P, McLeod D, Boyd CE, McWilliams N, Sartor O, Schumock GT, McCaffery K, Bennett CL. · Jesse Brown Veterans Affairs Medical Center Lakeside Community-Based Outpatient Clinic, IL, USA. · J Clin Oncol. · Pubmed #16314650 No free full text.

Abstract: In the course of recent health care fraud investigations against TAP Pharmaceuticals (Lake Forest, IL) and AstraZeneca International (London, United Kingdom), each pled guilty to one violation of the Prescription Drug Marketing Act, settled claims related to alleged violations of the False Claims Act without admitting guilt, and paid fines, settlements for liabilities, and reimbursements of dollar 850 million and dollar 355 million, respectively. In a unique aspect of these cases, federal investigators brought criminal charges against 14 TAP employees and investigated the billing practices of several urologists. These investigations resulted in guilty pleas from both urologists and industry employees relative to the Prescription Drug Marketing Act or the False Claims Act and probationary sentences with payments of fines and restitution to the government for urologists who cooperated with federal investigations. One uncooperative urologist was found guilty of violating the Federal False Claims Act and sentenced to 6 months of home arrest, excluded from Medicare for 5 years, required to provide 600 hours of free medical care to indigent patients and patients covered by Medicare or Medicaid, and paid fines and restitution to the government. The cases against TAP and AstraZeneca have been followed by federal and state investigations of allegedly illegal marketing practices of other pharmaceutical firms and have resulted in negotiated settlements of dollar 3.8 billion and dollar 71.5 million, respectively. Believing that an Average Wholesale Price-based reimbursement system was an important driving factor for these marketing activities, Medicare has shifted to an Average Sales Price-based reimbursement system. This is expected to greatly impact the practice of outpatient oncology nationwide.

Sartor O. · Department of Hematology/Oncology, Louisiana State University School of Medicine, Room 459, 533 Bolivar, New Orleans, LA 70112, USA. · Curr Oncol Rep. · Pubmed #12667425 No free full text.

Abstract: Hormone-refractory prostate cancer patients with painful bony metastatic lesions are potential candidates for bone-seeking radiopharmaceutical therapies. After careful assessment of symptoms and localization of pain, a bone scan is the single most useful imaging modality for the clinician to assess patients for the presence and distribution of osteoblastic lesions. Increased uptake (compatible with bony metastases) on a conventional bone scan is currently a prerequisite for treating patients with a bone-targeted therapeutic isotope. Determining whether metastatic bony involvement is focal or diffuse is also important in the clinical decision-making process. Patients with multifocal metastatic disease are excellent candidates for systemic therapies, whereas patients with unifocal metastatic disease may be more appropriate candidates for focal therapies such as external-beam radiation. Patients who are poorly tolerant of narcotics should be actively considered for alternative treatments such as systemic radiopharmaceuticals. Contraindications to administration of current bone-seeking radioisotopes include substantial degrees of renal insufficiency or bone marrow suppression.

Sartor O. · Stanley S. Scott Cancer Center, Louisiana State University School of Medicine, New Orleans, Louisiana 70112, USA. · Urology. · Pubmed #12231062 No free full text.

Abstract: Prostate cancer is an extraordinarily heterogeneous disease with a variety of prognostic factors influential in determining ultimate patient outcomes. However, the vast majority of men harboring pathologic evidence of prostate cancer are not clinically diagnosed with this disease. Selected patients, particularly those with low clinical stage and low Gleason scores, may have extremely prolonged time until disease progression and cancer-specific death. Because of the potential for a prolonged natural history, factors, such as age and comorbidities, are often critical in evaluating clinical trial outcomes. Patients with more aggressive disease (higher clinical stage or Gleason score) have less prolonged natural histories. Careful examination of inclusion and exclusion criteria and the presence of clinical or pathologic staging are necessary for proper interpretation of clinical trials. Although surrogate endpoints, such as prostate-specific antigen and pathologic state, are commonly used to assess the effectiveness of therapeutic interventions, the relations between these surrogates and more relevant clinical endpoints have not always been well defined. Although certain endpoints are generalizable (overall survival and cancer-specific survival), clinical stage and treatments dictate the appropriateness of many other clinical trial endpoints. Both disease-related and treatment-related endpoints are important, given the propensity for various interventions to alter quality of life. Prospective randomized trials with adequate follow-up time and the assessment of clinically meaningful endpoints will offer the best opportunity to evaluate the effectiveness of various interventions used in this disease.

Carroll PR, Kantoff PW, Balk SP, Brown MA, D'amico AV, George DJ, Grossfeld GD, Johnson CS, Kelly WK, Klotz L, Lee WR, Lubeck DP, Mcleod DG, Oh WK, Pollack A, Sartor O, Smith MR, Hart C, Anonymous00147. · Department of Urology, University of California School of Medicine, San Francisco, San Francisco, California, USA. · Urology. · Pubmed #12231036 No free full text.

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