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NEJM PSA Testing Study

Response to New England Journal of Medicine Study on PSA Testing

Radiotherapy Clinics of Georgia (RCOG) and ProstRcision.com


Prostate Cancer PSA Testing Alert:

Prostate-specific antigen (PSA) testing remains the most significant step for the testing for prostate cancer, according to ProstRcision.com and Radiotherapy Clinics of Georgia in Atlanta. It is suggested each man and his loved ones educate themselves about various screening methods and prostate cancer treatments before deciding on a course of action.

Two studies published by the New England Journal of Medicine include conflicting research about the efficacy of prostate-specific antigen (PSA) testing that contradict research gathered by Radiotherapy Clinics of Georgia (RCOG). RCOG is the only source for ProstRcision, the prostate cancer treatment with the highest documented cure rate in the world.

 

Statement

Recently, the New England Journal of Medicine published two studies that questioned the efficacy of prostate-specific antigen (PSA) testing in the screening for prostate cancer. Although RCOG respects the studies’ findings, we understand that conflicting research outcomes occur. Until additional research proves otherwise, we stand behind the use of PSA testing and believe that it should and will continue to be the most significant step in identifying prostate cancer. We encourage all men and their loved ones to educate themselves about the various prostate cancer screenings and treatments available and to discuss their options with a physician before deciding on the course of action that best meets their individual needs.

Q&A about PSA Testing Study by the New England Journal of Medicine.

Does this PSA testing study affect how RCOG thinks doctors should approach prostate cancer screenings?

No. Although it is important to evaluate the results of new research studies, annual PSA testing is still the standard of care in the detection and diagnosis of prostate cancer. PSA testing has been in widespread use for more than 20 years and has proven both instrumental and effective. The use of PSA testing has allowed early diagnosis so that a treatment like ProstRcision can be applied promptly. This has contributed partially to the achievement of an 83 percent cure.

How would you respond to the claim that PSA testing does more harm than good?

Prostate cancer is second only to lung cancer in cancer-related deaths in men. As with any cancer, early detection is an important key to survival along with efficient treatment. Following the adoption of the PSA test in 1986, improvements in detection and diagnosis led to a sharp increase in prostate cancer incidence in the late 1980s because doctors could more easily and accurately identify the existence of prostate cancer. Since the early 1990s, prostate cancer incidence and mortality rates have declined, a fact that has been attributed to the introduction of PSA testing coupled with the development of more effective treatment methods. The use of PSA testing has been and continues to be an important component of prostate cancer diagnosis and treatment, and we believe that the screening has helped save the lives of countless men through early detection. 

What is wrong with prostate cancer watchful waiting?

Although PSA testing can detect the presence of prostate cancer, there is no way to determine the cancer’s extent or aggressiveness. As such, prostate cancer that is left untreated can grow uncontrollably where it is and can spread quickly to other parts of the body, namely the skeletal system. This can lead to horrible bone pain and massive bleeding from the prostate area. The death that could occur from untreated prostate cancer is slow, painful, and agonizing. Prostate cancer is the second leading cause of cancer-related death in the United States, with 28,000 men dying from it last year alone. Early detection and treatment offers the best chance for cure, and watchful waiting only puts an individual at a greater risk. Though some men may be appropriate candidates for watchful waiting, this should only be the case after thorough evaluation of all factors by a medical team.

The length of each PSA testing study was 10 years. Is that long enough to reach an accurate conclusion about the value of PSA screening?

No. The length of each study does not constitute enough time to formulate an accurate conclusion because this was a study of PSA screening, not prostate cancer treatment. At this point, 177 men out of the 77,000 followed in the American study have died of prostate cancer. Because prostate cancer can be a slow-growing disease, it is possible that significant differences in the mortality rates of the two groups will emerge in the next several years. The studies, as a result, would need to follow the subjects for at least 20 years, allowing doctors and researchers to have 10 years worth of treatment data. In fact, the authors of the U.S. study discussed the possibility that over time the data could diverge, greatly changing their conclusion by indicating that PSA tests are valuable. This possibility is strengthened by the observation that their graphs appear to be separating at 10 years.

These studies shed light on the potential severe side effects associated with prostate cancer treatment. What is the risk of side effects associated with ProstRcision?

Although there are always risks associated with any treatment procedure, RCOG has worked diligently to reduce the side effects associated with prostate cancer treatment. With ProstRcision, there is almost no urinary leakage, with the exception of men who have had a prior TURP (roto-rooter operation). Chronic long-term rectal complications are also rare. Overall, 72 percent of men with good sexual function will maintain sexual function, although this is largely determined by a man’s age and quality of penile erection before treatment. Just as RCOG has built a database to assess the individual cure rate, we are currently developing the tools to provide an individualized report on the possibility of side effects, offering patients a greater understanding of their own risk.

What about men who are in prostate cancer high-risk groups, such as African Americans? 

Although all men are at risk, African Americans are diagnosed with prostate cancer at a rate 60 percent higher and die at a rate 150 percent higher than all other men in the United States. In fact, an African American man has approximately a one in five chance of being diagnosed with the prostate cancer. However, only 4.5 percent of men included in the U.S. study were African American, which is a gross underrepresentation of this high-risk group. In addition, only 7.1 percent of all the men in the study had a family history of prostate cancer, meaning that more than 90 percent of the men in the trial were not in a high-risk group.

What are the flaws in the New England Journal of Medicine PSA testing studies?

There are numerous flaws and biases in the two PSA testing studies, which could have skewed the data and conclusion significantly:

  • As aforementioned, both studies need to be extended for at least 10 more years to take into account the slow-growing nature of prostate cancer and to yield 10 years of treatment data. This is based on using the strictest definition of the cure of prostate cancer, which is a PSA of 0.2 ng/ml for 10 years.

  • Also cited above, the studies inadequately represent African Americans, who are at high risk for developing and dying from prostate cancer.

  • Another problem is “contamination” in the unscreened control group. As it would have been unethical to tell men in the control group that they could not be screened for prostate cancer, an estimated 38 to 52 percent either sought a PSA test or were offered it by their doctors. Also, 85 percent in the screened group were actually screened according to the protocol. This means that the study compares the difference between aggressive screening and less aggressive screening, as opposed to screening and no screening.

  • In the European study, men were offered PSA testing, which could be refused. However, if a man accepted and received a PSA test once in nine years, he was considered a member of the “screened” group, despite the fact that PSA tests are often part of a routine annual exam for men 50 years of age and older. To be deemed “screened,” men should have received annual as opposed to sporadic PSA tests.

  • Additionally, approximately half of the men in the American study had received a PSA screening in the past, meaning that those with prostate cancer were “weeded out” before the study ever started. This type of selection bias could greatly skew the data and increase the time to see a significant difference between the two groups.

  • The studies were not specific on the criteria used for referral to a urologist when an abnormality was found; there could have been undetected differences in the two groups. Their discussion indicated that a PSA of more than 4.0 ng/ml was the main factor. We know this is not adequate because the normal range is age dependent. For example, a man in the studies’ group at age 55 with a PSA of 3.0 ng/ml or a velocity change in older men, should be referred. This could have led to a higher number of cancers being detected earlier and at a more curable stage. They state in their discussion that blind referral at a PSA of more than 4.0 ng/ml for all men “may not be effective.”

  • Prostate cancer treatment improvements over time were not accounted for the course of the study period. It is difficult to determine, for example, what the death rate would have been if the men in the study had the benefit of the most curative treatments, such as ProstRcision.