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In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indications In September 2011, the monoclonal antibody RANKL...
When sipuleucel-T (Provenge) was approved by FDA in April 2010, it was the first vaccine to be approved as a treatment for prostate cancer and was hailed as a major advance. Although sipuleucel-T is now reimbursable by Medicare, some physicians are not clear about when to use it, and patients who...
Surgery did not increase survival rates compared to watchful waiting in men with clinically localized prostate cancer. Results were particularly strong for men with prostate-specific antigen (PSA) levels of 10 ng/dL and under, and those who have low-risk disease, according to data from the Prostate ...
Active surveillance of localized prostate cancer is a viable management option that should be offered to low-risk patients in place of immediate treatment, said a panel of experts convened by the National Institutes of Health. A fairly new concept, active surveillance takes a more proactive...
Although robotic-assisted laparoscopic radical prostatectomy “is eclipsing open radical prostatectomy among men with clinically localized prostate cancer,” the risks of problems with sexual functioning and continence are no lower with robotic than open surgery, according to a study in the Journal...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Abiraterone acetate (Zytiga) (an oral agent that...
Two novel agents with distinct mechanisms of action join ranks of treatments that extend survival for patients with castration-resistant prostate cancer: MDV3100 and radium-223. Both drugs achieved a survival advantage compared with placebo, with relatively benign side-effect profiles, according to ...
Gen-Probe announced the FDA has approved its PROGENSA PCA3 (prostate cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. “Overexpression of the PCA3 gene is highly specific to cancerous prostate...
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 that the risk-benefit ratio was insufficient for an expanded use of denosumab (Xgeva) to delay the spread of prostate cancer to the bone in men with castration-resistant disease. The panel was not asked specifically whether it...
Sipuleucel-T (Provenge) can generate a circulating immune response to treat men with metastatic castrate-resistant prostate cancer, as per its FDA-approved indication.1 A neoadjuvant trial was performed to investigate whether earlier use of sipuleucel-T can generate an immune response in the...
The recent 2012 Genitourinary Cancers Symposium featured a wealth of presentations on prostate, bladder, kidney, and other genitourinary cancers. Brief summaries of some of the oral and poster sessions are presented. Exercise and Recurrence Vigorous exercise has been shown to reduce cancer...
Nicholas B. Vogelzang, MD, moderator of the press briefing where these findings were presented, agreed that the first study supports intensity-modulated radiotherapy (IMRT) as the current standard of care. With costs of health care increasing exponentially, it is important to establish the...
Patients with prostate cancer are treated with various forms of radiotherapy and/or radical prostatectomy with little comparative data to inform treatment selection. Two studies presented at the 2012 Genitourinary Cancers Symposium attempt to address that gap. In one study of men with localized...
A study presented at the 2016 Genitourinary Cancers Symposium showed that 40% of patients with metastatic castration-resistant prostate cancer treated with docetaxel following abiraterone (Zytiga) had at least a 50% reduction in prostate-specific antigen (PSA), demonstrating the activity of...
An early study suggests that an experimental blood test may help guide individualized decisions on the most appropriate treatments for patients with prostate cancer. The new noninvasive “liquid biopsy” scans the entire landscape of different kinds of cancer cells in blood and analyzes...
A large observational study has found that men who take aspirin regularly may have a lower risk of dying from prostate cancer. Men who took aspirin regularly after their prostate cancer diagnosis were less likely to die from the disease. However, aspirin did not affect the overall incidence of...
“Analyses after 2 additional years of follow-up consolidated our previous finding that [prostate-specific antigen (PSA)]-based screening significantly reduced mortality from prostate cancer but did not affect all-cause mortality,” investigators from the European Randomized Study of Screening for...
Although androgen-deprivation therapy is effective in inducing regression of androgen-dependent prostate cancer, relapse often occurs in an androgen-independent manner and is associated with poor prognosis. The mechanisms underlying castration resistance are not fully understood. Sung and...
Researchers at Memorial Sloan-Kettering Cancer Center have developed the Bone Scan Index (BSI), which is the first quantitative imaging response biomarker that can assess response to treatment and prognosticates for survival in men with metastatic castration-resistant prostate cancer. Based on Bone ...
Supplements touted as preventing prostate cancer may turn out to be dangerous, as is evident from updated results of the largest long-term prevention trial, called the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Final analysis of SELECT showed that, compared to placebo, vitamin E alone ...
Short-term androgen deprivation therapy does not appear to increase cardiovascular mortality in men with clinically localized prostate cancer, according to a post hoc analysis of a large Radiation Therapy Oncology Group (RTOG)-sponsored clinical trial.1 “Our study analyzes data from a large...
A recent press briefing moderated by Phil B. Fontanarosa, MD, MBA, Executive Editor, JAMA, presented new findings on comparative effectiveness research, and two of the studies discussed focused on cancer. Dr. Fontanarosa started by defining comparative effectiveness research, which gained...
Many of the almost 100 reports in various journals and newspapers refer to the lack of effect on overall mortality with screening in ERSPC in a very critical fashion. Clarification is necessary. Our trial did not intend to and is not powered to study the effect of screening on overall mortality....
Studies assessing the effect of prostate-specific antigen (PSA) testing on prostate cancer mortality have produced conflicting results, and recommendations regarding PSA screening vary among authorities. The recently published 11-year follow-up of the European Randomized Study of Screening for...
Scientific advances have markedly improved prostate cancer survival, but this clinical success story is not without its share of controversy. From screening through treatment, a growing array of options offer an admixture of promise and confusion for clinicians and patients. Moreover, today’s...
Hypoxia often occurs early in solid tumor development as a result of imbalances between oxygen supply and consumption and may lead to genetic and molecular signaling that influences the biology and clinical behavior of tumors and response to treatment. Milosevic and colleagues from Princess...
Denosumab (Xgeva) significantly delayed time to first bone metastases among men with nonmetastatic castration-resistant prostate cancer enrolled in a phase III randomized, placebo-controlled trial. The time to first bone metastasis was 33.2 months among the 716 patients randomly assigned to receive ...
Use of the CYP17 inhibitor abiraterone acetate (Zytiga) in combination with leuprolide and prednisone prior to radical prostatectomy achieved pathologic complete response or near complete response in one-third of men with high-risk, localized prostate cancer. Abiraterone is FDA-approved for...
Janssen Research & Development, LLC, has submitted a supplemental New Drug Application (sNDA) to the FDA to extend the use of abiraterone acetate (Zytiga) administered with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or...
Based on the controversial nature of the SWOG 9346 findings, presented at the 2012 Annual Meeting Plenary Session, ASCO intiated a pilot program at the meeting for a “town hall” type of discussion, where attendees could voice their concerns and questions, and where presenter Maha Hussain, MD,...
Based on a prespecified definition of survival comparability, intermittent androgen deprivation proved to be inferior to continuous androgen deprivation for men with newly diagnosed hormone-sensitive metastatic prostate cancer in the phase III SWOG 9346 intergroup trial. The data were presented at...
In the May 15 issue, The ASCO Post reported on the relative cost-effectiveness of approaches to treating localized prostate cancer (“Advances in Prostate Cancer Accompanied by Ongoing Debates,” page 1). The article analyzed an important scientific paper presented at both urology and radiation...
The U.S. Preventive Services Task Force (USPSTF) recently issued a recommendation statement advising against the use of prostate-specific antigen (PSA)-based testing for prostate cancer,1 leaving many in the oncology community concerned that decades of clinical progress will be stalled, and setting ...
Hypoxia often occurs early in solid tumor development as a result of imbalances between oxygen supply and consumption and may lead to genetic and molecular signaling that influences the biology and clinical behavior of tumors and response to treatment. Milosevic and colleagues from Princess...
Beckman Coulter, Inc, recently announced Premarket Approval from the FDA for the Prostate Health Index, a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than prostate-specific antigen (PSA) in patients with PSA values in the 4 to 10 ng/mL range and has...
Serum levels of prostate-specific antigen (PSA) are widely used as a biomarker for prostate cancer, although they often do not distinguish between normal tissue and cancer and do not always accurately reflect clinical outcome. In order to overcome the fact that the small proportion of...
Medivation, Inc, and Astellas Pharma, Inc, announced that the FDA has accepted for filing the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted...
U.S. Senator John F. Kerry (D-MA) led unanimous passage of Senate Resolution 493 to recognize prostate cancer as an epidemic striking African American men disproportionately, with 250% higher mortality and 60% higher incidence. This bipartisan legislation urges federal agencies to support research...
Population screening to identify preclinical disease is considered a central factor in the decades-long decrease in mortality seen in certain cancers. However, hope in the face of deadly disease can sometimes blind us to the scientific evidence. According to the recent U.S. Preventive Services Task ...
Given my explanation and widely publicized opinion on the improper use of the prostate-specific antigen (PSA) test for screening asymptomatic men for prostate cancer—most recently expressed in a feature article in The ASCO Post (August 15, 2012)—I was pleased to read that Drs. James Mohler and...
An article that appeared in the August 15 issue of The ASCO Post (“Rethinking the Role of PSA Screening in Public Health”) contains false statements about the discovery of prostate-specific antigen (PSA) and its effectiveness as a test for early detection of prostate cancer. Contrary to what’s...
“Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy” in an international phase III, double-blind, placebo-controlled trial, investigators reported in The New England Journal of Medicine. Median overall survival, the...
The FDA has approved enzalutamide (Xtandi) to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for patients with prostate cancer previously treated with docetaxel, enzalutamide was...
Janssen Research & Development, LLC, announced that the FDA has granted Priority Review to the supplemental New Drug Application (sNDA) for abiraterone acetate (Zytiga) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer ...
The relative benefits of surgery or observation in men with prostate cancer detected by prostate-specific antigen (PSA) testing have not been defined. Randomized trials comparing radical prostatectomy with observation were conducted before widespread use of PSA testing and an observational study...
Three emerging agents for castration-resistant prostate cancer are extending lives and defining their roles in the treatment scenario, according to William Oh, MD, of Mount Sinai School of Medicine, New York, who commented on new data at the Best of ASCO Boston meeting. “We are talking about...
Continuous androgen deprivation therapy remains the standard of care for newly diagnosed hormone-sensitive metastatic prostate cancer, according to the phase III Southwest Oncology Group (SWOG) 9346 intergroup trial presented at this year’s ASCO Plenary Session.1 Study Rationale The large...
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Over the past few weeks, Stanley L....
The FDA approved the production and use of Choline C 11 Injection, a positron-emission tomography (PET) imaging agent used to help detect recurrent prostate cancer. Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue ...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In August 31, enzalutamide (Xtandi) was approved for the ...