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A DRAMATIC increase in prostate cancer cases has prompted calls for men to think carefully before being tested.
A new study shows the number of diagnoses in Australia jumped 276 per cent over the 20 years from 1987 to 2007.
This is a result of increased testing, says lead author Associate Professor Freddy Sitas of Cancer Council NSW.
He says the PSA test and physical examination are unreliable, giving both false positives and false negatives.
Even if a positive result is correct, unless they operate, doctors have no fool-proof way of knowing if the cancer is aggressive or relatively harmless.
"Saving lives is our priority, but we urgently need a better test," says Prof Sitas.
"The tests have saved men with aggressive forms of the disease, but at a high cost."
A 27 per cent drop in the death rate was observed over the study period, he says. However, the increase in new cases is much greater than this.
"This indicates that many men were diagnosed with cancers that would not have harmed them."
The University of NSW's Professor Mark Harris says: "Until we have a better method of screening, men need to be fully informed about the pros and cons of testing.
"GPs have to be very well informed so they can give the best advice."
It's a difficult area, says Professor Sandro Porceddu, President of Clinical Oncology Society of Australia.
About 30 per cent of PSA tests will give false positives.
"In other words there will be a group of people who have an elevated PSA but do not have prostate cancer.
"This can lead to further investigations, which have their own side effects."
He says there is no right or wrong answer for men trying to decide whether to be screened or not.
"Men who do have a concern should have a good and thorough talk to their doctor about the implications.
"The patient needs to decide if it is the most appropriate thing for them."
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up By Charles Bankhead, Staff Writer, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San FranciscoNote that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.Almost a third of men on active surveillance for prostate cancer had an upgrade in Gleason pathology grade during follow-up, biopsy results for almost 600 patients showed.Point out that clinical stage at diagnosis, PSA velocity, number of involved biopsy cores, and the interval to follow-up biopsy predicted an increased likelihood of Gleason upgrading.
ORLANDO -- Almost a third of men on active surveillance for prostate cancer had an upgrade in Gleason pathology grade during follow-up, biopsy results for almost 600 patients showed.
During median follow-up of 6.4 years, 31.3% of the localized cancers were upgraded. The proportion of men with upgraded tumors increased over time, D. Andrew Loblaw, MD, reported here at the Genitourinary Cancers Symposium. "This increase over time was not statistically significant, but it allows for some hypothesis generation."
Clinical stage at diagnosis, PSA velocity, number of involved biopsy cores, and the interval to follow-up biopsy predicted an increased likelihood of Gleason upgrading, according to Loblaw, who practices at Sunnybrook Health Sciences Center in Toronto.
Intermediate-risk tumors had an upgrade probability more than double that of low-risk tumors -- 1.9% per year compared with 0.75%, although the difference did not achieve statistical significance.
"Gleason upgrading increases with time from diagnostic biopsies and might be higher in patients with initial Gleason 7 disease as opposed to Gleason 6," Loblaw said.
Men with localized prostate cancer have a 10-year disease-specific survival exceeding 97%, making active surveillance a reasonable option for many patients. Considerable research has focused on factors that can identify men who have an increased risk of progression, but pathologic upgrading has received little attention, said Loblaw.
In the largest published study to date, investigators at the University of California San Francisco found that a third of 377 patients in surveillance had pathologic upgrading of their tumors during 4 years of follow-up (J Clin Oncol 2011; 9: 2185-2190).
However, studies have produced little information about factors associated with upgrading, said Loblaw. In an effort to gain some insight into those factors, he and his colleagues analyzed a prospective database of patients entered into active surveillance at Sunnybrook Health Sciences Center
Eligibility for active surveillance required a biopsy Gleason score =6 and a PSA level =10 ng/mL. For patients older than 70, the criteria consisted of a Gleason score =3+4 and a PSA level =15 ng/mL.
Patients had repeat PSA testing every 3 months for 2 years and then every 6 months thereafter. Scheduled follow-up biopsies occurred after 1 year and then every 3 years until age 80.
Patients and physicians considered active treatment in the event of a PSA doubling time <3 years, histologic upgrading, and clinical progression, as well as patient preference.
As of August 2012, the database included 862 patients, including 592 who had at least one repeat biopsy. The subgroup of re-biopsied patients had a median age of 68 and a median baseline PSA of 5.5 ng/mL.
Loblaw reported that 83% of the patients had T1 disease and 17% had T2. Additionally, 20.2% of patients had intermediate-risk disease, 0.3% had high-risk prostate cancer, and 79.4% had low-risk cancer.
Multivariate analysis of baseline and dynamic factors associated with upgrading identified clinical stage at diagnosis (OR 2.301, P=0.0028), percentage of involved prostate biopsy cores at diagnosis (OR 1.768, P=0.0007), PSA velocity >2 (3.274, P<0.0001), and interval to re biopsy (OR 1.437, P=0.0102).
Subsequently, 114 (62%) of men whose tumors were upgraded chose to undergo treatment. The investigators found that a higher proportion of treated patients had a Gleason score of 8 (22% versus 2.9% of untreated patients), and treated patients had a significantly higher PSA velocity (1.2 versus 0.42 ng/mL/y, P=0.01).
The likelihood of upgrading increased over time, including 18.4% of patients followed for up to a year to 36% of patients followed for 7 to 8 years, 36% of patients followed for 8 to 9 years, and 26% of patients followed for more than 9 years.
In the discussion that followed the presentation, a panel of prostate cancer specialists and the audience engaged in a prolonged discussion about the future of surveillance for localized prostate cancer. Eric Klein, MD, of the Cleveland Clinic, suggested the time has come to reconsider the focus of surveillance.
"We have all patted ourselves on the back that we can identify patients who aren't going to die of their prostate cancer, with appropriate surveillance criteria," said Klein. "Shouldn't we raise the bar now?
"Given the cost and morbidity of metastatic disease [should we be asking] how much longer patients with metastatic disease are living? Should we say the goal of therapy or surveillance ought to be to avoid metastatic disease, rather than simply avoid death?"
The Genitourinary Cancers Symposium is co-sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.
Loblaw and co-investigators had no relevant disclosures.
Primary source: Genitourinary Cancers Symposium Source reference: Jain S, et al "Gleason upgrading with time in a large, active surveillance cohort with long-term follow-up" GuCS 2013; Abstract 1.
Charles Bankhead
Staff Writer
Working from Houston, home to one of the world's largest medical complexes, Charles Bankhead has more than 20 years of experience as a medical writer and editor. His career began as a science and medical writer at an academic medical center. He later spent almost a decade as a writer and editor for Medical World News, one of the leading medical trade magazines of its era. His byline has appeared in medical publications that have included Cardio, Cosmetic Surgery Times, Dermatology Times, Diagnostic Imaging, Family Practice, Journal of the National Cancer Institute, Medscape, Oncology News International, Oncology Times, Ophthalmology Times, Patient Care, Renal and Urology News, The Medical Post, Urology Times, and the International Medical News Group newspapers. He has a BA in journalism and MA in mass communications, both from Texas Tech University.
Register TodayEarn Free CME Credits by reading the latest medical news in your specialty.Sign Up By Charles Bankhead, Staff Writer, MedPage Today Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse PlannerThis study prospectively evaluated in routine clinical practice, the frequency of occult type 1 provenance errors (complete transposition between patients) and type 2 provenance errors (contamination of the target patient's tissue with that of one or more unrelated patients) among a number of urology practices and surgical pathology laboratories.Note that the study suggests that prospective DNA testing to confirm the identity of prostate biopsies that show adenocarcinoma may be useful for preventing treatment errors stemming from misidentification.
As many as 3.5% of prostate biopsy specimens were contaminated or inadvertently switched with that of another patient, according to a review of 13,000 samples from 54 laboratories.
The overall error rate was less than 1%, but rates among different types of labs ranged as high as 3.51%. No laboratory included in the study had an error-free performance record.
Institutional approval for the study required investigators to remove all identifying information from the specimens. Consequently, the impact of the laboratory errors could not be assessed, as reported online in the American Journal of Clinical Pathology.
"It is possible that in a subset of cases, the adenocarcinoma from the foreign patient that was the source of the extraneous tissue exhibited sufficiently similar characteristics of the target patient such that either patient's diagnosis would have resulted in the same course of therapy," John D. Pfeifer, MD, PhD, and Jingxia Liu, PhD, of Washington University in St. Louis, wrote of their findings.
"Regardless of the portion of cases in which patients may have, by chance, received the correct treatment despite the specimen identity error, the fact remains that ... a diagnosis was assigned to the wrong patient with no knowledge or even suspicion of the error that had occurred."
The study examined the frequency of occult "specimen provenance complications" (SPCs), errors that occur without any indication of a problem. SPCs arise when specimens are matched to the wrong patients (type 1 error) or when one patient's specimen is contaminated by tissue from one or more other patients (type 2 error).
SPCs have obvious implications for patient safety and medicolegal actions, the authors noted in their introduction. However, the frequency with which these errors occur has remained unclear.
To describe the rates of both types of SPCs, Pfeifer and Liu analyzed data for 13,000 prostate biopsy specimens obtained in routine clinical practice. The specimens were processed by a variety of surgical pathology and urology group practice laboratories.
Data for the study came from Strand Analytical Laboratories, an Indianapolis company that has developed a DNA-based test for occult SPCs. The test employs short tandem repeat (STR) analysis, originally developed by the FBI.
"STR analysis has been shown to be particularly useful in identifying occult specimen identity errors," the authors noted in their introduction.
The investigators grouped the 54 laboratories into five categories based on work flow, location, and management structure: physician-owned labs within a group-practice setting, independent reference labs, hospital labs, nonphysician owned labs located in facilities shared with group practices, and labs that have the technical histopathology and professional pathology in separate facilities, necessitating transport of specimen slides.
The error rate for all labs combined was low: 0.26% for type 1 errors and 0.67% for type 2 errors. However, the authors pointed out, each SPC involved at least two patients, "the target patient and the foreign patient (or patients) whose tissue was misidentified as originating from the target patient."
Reference laboratories had the highest rate of SPCs: 0.37% for type 1 and 3.14% for type 2, resulting in an overall error rate of 3.51%.
Only one clinical trial has attempted to document SPCs, according to the authors. The Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial took steps to measure the rate of SPCs after three cases of occult biopsy specimen misidentification occurred during the first 2 years.
The rate of type 1 errors was 0.4% during the first 2 years of the REDUCE trial and declined to 0.02% in the final 2 years, after investigators implemented changes in specimen-handling procedures. A type 1 error rate of 0.5% persisted throughout the trial for blood samples that served as reference specimens.
Based on their study, the authors suggested that prospective DNA testing to confirm the identity of prostate biopsies that show adenocarcinoma may be useful for preventing treatment errors stemming from misidentification.
Strand Analytical Laboratories, which developed a test for STR analysis, provided the data for the study.
The authors had no relevant disclosures.
Charles Bankhead
Staff Writer
Working from Houston, home to one of the world's largest medical complexes, Charles Bankhead has more than 20 years of experience as a medical writer and editor. His career began as a science and medical writer at an academic medical center. He later spent almost a decade as a writer and editor for Medical World News, one of the leading medical trade magazines of its era. His byline has appeared in medical publications that have included Cardio, Cosmetic Surgery Times, Dermatology Times, Diagnostic Imaging, Family Practice, Journal of the National Cancer Institute, Medscape, Oncology News International, Oncology Times, Ophthalmology Times, Patient Care, Renal and Urology News, The Medical Post, Urology Times, and the International Medical News Group newspapers. He has a BA in journalism and MA in mass communications, both from Texas Tech University.
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