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Prostate Cancer News

Wednesday, May 8, 2013 // Uncategorized

There have been several news items about prostate cancer in the last few days having to do with the diagnosis and treatment of prostate cancer.

Here are the new guidelines on prostate cancer screening from the American Urologic Association.  The USPSTF had recommended against screening for prostate cancer as they felt that the net harm outweighed the benefit.  The American Urologic Associations guidelines represent a response to this.

Guideline Statements

Guideline Statement 1: The Panel recommends against PSA screening in men under age 40 years. (Recommendation; Evidence Strength Grade C)

  • In this age group there is a low prevalence of clinically detectable prostate cancer, no evidence demonstrating benefit of screening and likely the same harms of screening as in other age groups.

Guideline Statement 2: The Panel does not recommend routine screening in men between ages 40 to 54 years at average risk. (Recommendation; Evidence Strength Grade C)

  • For men younger than age 55 years at higher risk (e.g. positive family history or African American race), decisions regarding prostate cancer screening should be individualized.

Guideline Statement 3: For men ages 55 to 69 years the Panel recognizes that the decision to undergo PSA screening involves weighing the benefits of preventing prostate cancer mortality in 1 man for every 1,000 men screened over a decade against the known potential harms associated with screening and treatment. For this reason, the Panel strongly recommends shared decision-making for men age 55 to 69 years that are considering PSA screening, and proceeding based on a man’s values and preferences. (Standard; Evidence Strength Grade B)

  • The greatest benefit of screening appears to be in men ages 55 to 69 years.

Guideline Statement 4: To reduce the harms of screening, a routine screening interval of two years or more may be preferred over annual screening in those men who have participated in shared decision-making and decided on screening. As compared to annual screening, it is expected that screening intervals of two years preserve the majority of the benefits and reduce overdiagnosis and false positives. (Option; Evidence Strength Grade C)

  • Additionally, intervals for rescreening can be individualized by a baseline PSA level.

Guideline Statement 5: The Panel does not recommend routine PSA screening in men over age 70 years or any man with less than a 10 to 15 year life expectancy. (Recommendation; Evidence Strength Grade C)

  • Some men over age 70 years who are in excellent health may benefit from prostate cancer screening.

 

The American Urologic Association and american Society of Radiation Therapy released new guidelines on treating patients who have had their prostates removed with radiation if their are determined to be at high risk for recurrence.  Formerly, they had radiation if their cancer recurred.

 

Guideline Statements:

1. CLINICAL PRINCIPLE

. Patients who are being considered for management of localized prostate cancer with radical prostatectomy should be informed of the potential for adverse pathologic findings that portend a higher risk of cancer recurrence and that these findings may suggest a benefit of additional therapy after surgery.

2. CLINICAL PRINCIPLE

. Patients with adverse pathologic findings including seminal vesicle invasion, positive surgical margins, and extraprostatic extension should be informed that adjuvant radiotherapy, compared to radical prostatectomy only, reduces the risk of biochemical (PSA) recurrence, local recurrence, and clinical progression of cancer. They should also be informed that the impact of adjuvant radiotherapy on subsequent metastases and overall survival is less clear; one of two randomized controlled trials that addressed these outcomes indicated a benefit but the other trial did not demonstrate a benefit. However, the other trial was not powered to test the benefit regarding metastases and overall survival.

3. STANDARD.

Physicians should offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy including seminal vesicle invasion, positive surgical margins, or extraprostatic extension because of demonstrated reductions in biochemical recurrence, local recurrence, and clinical progression. (Body of Evidence Strength Grade A)

4. CLINICAL PRINCIPLE.

 

Patients should be informed that the development of a PSA recurrence after surgery is associated with a higher risk of development of metastatic prostate cancer or death from the disease. Congruent with this clinical principle, physicians should regularly monitor PSA after radical prostatectomy to enable early administration of salvage therapies if appropriate.

5. RECOMMENDATION

 

. Clinicians should define biochemical recurrence as a detectable or rising PSA value after surgery that is ≥ 0.2 ng/ml with a second confirmatory level ≥ 0.2 ng/ml.

6. OPTION.

 

A restaging evaluation in the patient with a PSA recurrence may be considered. (Body of Evidence Strength Grade C)

7. RECOMMENDATION.

 

Physicians should offer salvage radiotherapy to patients with PSA or local recurrence after radical prostatectomy in whom there is no evidence of distant metastatic disease. (Body of Evidence Strength Grade C)

8. CLINICAL PRINCIPLE.

 

Patients should be informed that the effectiveness of radiotherapy for PSA recurrence is greatest when given at lower levels of PSA.

9. CLINICAL PRINCIPLE

 

. Patients should be informed of the possible short-term and long-term urinary, bowel, and sexual side effects of radiotherapy as well as of the potential benefits of controlling disease recurrence.

 

And finally, whose prostate cancers should be treated aggressively?  Not all cancers are the same.  Some are low grade and won’t affect longevity and others are aggressive and will.  Avoiding treatment of low grade cancers would help avoid the cost and side effects.  Presently these decisions are made based on the Gleason’s score (an estimate of aggressiveness based on the appearance under the microscope) and the number of biopsies which have cancer in them.  The following is an article from today’s New York Times which details a new genetic test which may help stratify risk in men with prostate cancer.  It’s effectiveness has yet to be proven and it is expensive costing around $3800!

May 8, 2013
New Test Improves Assessment of Prostate Cancer Risk, Study Says

A new test can help distinguish aggressive prostate cancer from less threatening ones, potentially saving many men from unneeded operations for tumors that would never hurt them, researchers are reporting.

The test, developed by Genomic Health, could triple the number of men who could confidently monitor their tumors rather than undergo surgery or radiation treatments, according to the company and to researchers.

Results of a study assessing the test’s performance will be presented Wednesday at the annual meeting of the American Urological Association in San Diego.

Many of the 240,000 cases of prostate cancer diagnosed each year in the United States are considered to pose a low risk of hurting or killing the man. But sometimes those assessments are wrong. So many men, reluctant to take the chance, undergo treatments that can cause impotence and incontinence.

“It’s very hard to tell a surgeon ‘I’d like to leave a cancer in place,’ ” said Dr. Jonathan Simons, president of the Prostate Cancer Foundation, a research and advocacy organization. “Having objective information is going to help a lot of patients make that decision.”

Dr. Simons, who was not involved in the study, said the development of new genetic tests like the one from Genomic Health represented a “watershed,” akin to going from pulse rate measurements to electrocardiograms in cardiology.

Still, some experts said it was too early to assess how accurate the test really was and whether it would make a difference in men’s decisions. Insurers are going to want to know that before deciding to pay for the test, which will be available starting Wednesday at a list price of $3,820.

Even the senior investigator of the study, Dr. Peter R. Carroll, said he was not sure.

“Certainly for a group of men it will have an impact,” Dr. Carroll, who is chairman of urology at the University of California, San Francisco, said in an interview. “The question is how many men and how many physicians.”

The new test, which is called the Oncotype DX Prostate Cancer Test, is one of more than a dozen coming to market that use advanced genetic methods to help better manage prostate cancer. The most direct competitor to the Oncotype test is likely to be the Prolaris test, introduced last year by Myriad Genetics.

But Genomic Health’s test has attracted attention because of the company’s track record. It already sells a similar test for breast cancer, also Oncotype DX, that is widely used to help women decide whether they can forgo chemotherapy after their tumor is surgically removed.

Some analysts say that with the breast cancer test facing intensified competition, the company’s future growth could hinge on the prostate test, which could take time to gain acceptance. Genomic Health’s stock closed Tuesday at $33.87, up 1 percent.

The test looks at the activity level of 17 genes in the biopsy sample and computes a score from 0 to 100 showing the risk that cancer is aggressive.

To see how well the test worked, testing was performed on archived biopsy samples from 412 patients who had what was considered low or intermediate-risk cancer but then underwent surgery.

In many such cases, the tumor, which can be closely studied after it is surgically removed, turns out to be more aggressive than thought based on the biopsy, which looks at only a tiny sample of the tumor.

The researchers found that the Oncotype test predicted such unfavorable pathology more accurately than existing methods, which depend mainly on the Gleason score based on how the biopsy sample looks under the microscope.

Genomic Health said that 26 percent of the samples were classified as very low risk by its test, compared to only 5 to 10 percent for the existing methods. In some cases, however, the new test showed the cancer to be more aggressive than the existing methods.

Some experts not involved in the study were cautiously optimistic.

“They showed a pretty good correlation with the score and how it predicts things,” said Dr. E. David Crawford, a professor of urology, surgery and radiation oncology at the University of Colorado. He has consulted for Myriad Genetics and said he might become a consultant to Genomic Health.

Dr. Stacy Loeb, assistant professor of urology at New York University, said, “I think it will help — they definitely showed it improves upon what we are using now.” She said it was not clear, however, how the Genomic Health and Myriad tests compared to each other.

 

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