Predicting Survival after Prostate Surgery

(6/3/14)- The results of a new study that was presented at the annual meeting of the American Society of Clinical Oncology in Chicago concluded that men given chemotherapy early in their treatment for advanced prostate cancer lived a median of nearly 14 months longer than those who did not get early chemotherapy.

The study’s findings apply to a narrow group of patients, namely, men whose cancer had already spread beyond the prostate gland at the time of diagnosis, or whose cancer had come back after surgery or radiation treatment and still remain susceptible to hormone treatment.

The study was sponsored by the National Cancer Institute, and involved 790 men who received either only hormone therapy or hormone therapy in addition to at most 6 infusions of docetaxel spaced 3 weeks apart.

Those who received the chemotherapy lived a median of 57.6 months, compared with 44 months in the control group. Docetaxel is sold under the brand name Taxotere by Sanofi, the French drug company. It was approved for metastic prostate cancer in 2004. Zytiga from Johnson & Johnson and Xtandi from Medivation and Astellas Pharma have also received FDA approval for treatment of advanced prostate cancer.

(5/14/13)- One of the questions facing men diagnosed with prostate cancer involves the type of treatment the patient should undergo in battling the disease. One of the new tests that may help determine which way to go is called the Oncotype DX Prostate Cancer Test. It is one of about a dozen that have come or are about to come to market that use advanced genetic methods to help determine how aggressive the tumor is.

This test, developed by Genomic Health is but another tool that will help the physician and the patient determine what path should be followed in fighting the disease.

There are approximately 240,000 new prostate cancer diagnoses in the United States each year, but many of them are low risk situations where benign neglect might be the best path to follow. This is especially true in the case of older prostate patients where the tumor grows slowly.

The test is expensive since it costs $3,280. The most direct competitor to the Oncotype test is the Prolaris test, introduced last year by Myriad Genetics.

The test examines the activity level of 17 genes in the biopsy sample and computes a score from 1 to 100 showing how aggressive the cancer may be.

The clinical trial for the test involved examining the biopsy samples from 412 patients who had what was considered low or intermediate risk cancer but then underwent surgery.

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

(9/13/11)- The European Medicines Agency (EMA) approved Johnson & Johnson's new late-stage prostate cancer treatment drug Zytiga, also known as abiraterone acetate after a fast-track review. EMA advisers had endorsed the treatment in July, and the U.S. Food and Drug Administration (FDA) had approved it in April.

Patients with advanced prostate cancer who were given the drug lived on average 15.8 months compared with 11.2 months for those men given the placebo.

In addition to Zytiga, other drugs now available for late-stage prostate cancer include Dendreon Corp.'s Provenge and Jevtana from Sanofi SA.

(4/25/09)- Dendreon Corp. said that it would officially announce the results of its prostate cancer drug Provenge on April 28th at a meeting of the American Urological Association. At the same time the company's chief executive, Mitchell H. Gold, told analysts in a conference call that the outcome was "unambiguous" and met the goals the company and the FDA had agreed upon.

Please keep in mind the fact that the FDA has still not voted to approve the drug as safe for sale to the general public.

Dr. Gold went on to say that the drug would have had to reduce the risk of death by 22% compared with a placebo to meet the FDA's requirement for statistical significance.

We discussed this matter in our item dated 4/10/07 below, and also in an item dated 5/26/07 in our items in the article Basic Information on Prostate Cancer .

We also discussed this matter in our items on The Federal Food and Drug Administration (FDA). We have extracted from that article the following item:

(12/20/07)- Representatives Dan Burton, Michael H. Michaud and Tim Ryan called for hearings to investigate the FDA's rejection of the application of Dendreon Corp.'s experimental prostate cancer drug Provenge. The agency rejected approval of the drug in May even though the advisory panel had recommended acceptance of the drug by a 13-to-4 vote in March.

The agency said that it would require the company to produce results from another study in order to win the approval. The Congressmen cited the fact that the inquiry would be centered on the fact that two members of the advisory panel who had argued against approval of the drug had potential conflict -of- interest issues in the matter.

The two members who had the potential conflict-of-interest were Dr. Howard I. Scher of Memorial Sloan-Kettring Center in New York, and Dr. Maha Hussain of the University of Michigan. Dr. Scher is the lead investigator for a trial for a competing experimental drug made by Novacea and advises a venture capital firm that invests in that company.

If the FDA does approve the drug, it would be the first so-called therapeutic cancer "vaccine" to win approval in the U.S. The trial in question involved 512 patients whose cancer had spread beyond the prostate gland, and were no longer benefiting from normal therapy treatment.

In the early results of the trial those men who were on Provenge lived a median of 25.9 months compared with 21.4 months for those who received a placebo. At the end of three years, 34% of the men taking Provenge were alive, compared with only 11% for those who received the placebo.

Please keep in mind that the drug had failed its primary objective of whether it had delayed the worsening of the cancer, even though it did prolong the life of the patients taking the drug.

(4/15/09)- Although there are many ways to treat prostate cancer, statistics show that if the cancer is confined to the prostate, there is a 90% "cure" rate- which means patients re free of cancer for at least five years- no matter which treatment is chosen.

The US has the highest survival rate for prostate cancer, of all 31 countries included in the CONCORD study of 101 cancer registries on 5 continents. A Gleason score, which is based on the pattern of abnormal cells seen in the biopsy, of Gleason 6 means the cancer is at, or below low-grade, whereas a Gleason score of 7 or above is more worrisome.

Traditional biopsy samples can miss cancers in about 20% of the cases, and may miss the most advanced spots.

(4/19/08): At the American Society for Clinical Oncology symposium on genitourinary cancers, Dr. Grace Lu-Yao presented a paper which suggested that, "For elderly men, the survival benefit of treatment (of prostate cancer) is most likely modest. The majority of patients died of other complications or were still alive."

Subjects were 9,018 men diagnosed with stage I or II prostate cancer between 1992 and 2002, the era of prostate-specific antigen (PSA) screening. It is estimated that PSA testing can detect prostate cancer 6-13 years before the slow-growing disease is diagnosed clinically.

Anyone who had local therapy or hormonal therapy in the 6 months after initial diagnosis was excluded from the study. More than 5000 men were older than 75, with the study median age being 77. Although 2,675 men received treatment subsequently, long periods without treatment were common. The median interval between diagnosis and start of cancer treatment was 127 months.

About two-thirds of the population was categorized as either dying from other causes or not experiencing a cancer progression for which they were treated with surgery or radiation.

(Material for this article was taken verbatim from Family Practice News, March 15, 2008 from the article written by Jane Salodof MacNeil)

(7/28/07)- A study conducted by researchers at Memorial Sloan-Kettering Cancer Center in New York concluded that prostate cancer is less likely to relapse if the patient had been treated by a more experienced surgeon. Surgeons who have conducted more than 250 cancerous prostate operations had a better record of having successful procedures than those surgeons who had done a lesser amount of this type of procedure.

The results of the study were published in a recent edition of the Journal of the National Cancer Institute. More than 7,700 men with prostate cancer who were treated, by 72 American surgeons from 1987 to 2003 were included in the study.

Five years after a prostatectomy, about 18% of men under the care of an inexperienced surgeon, those with no more than 10 prior operations, were more likely to see signs that cancer had returned.

The Prostate Cancer Foundation estimates that there are 218,000 American men who are found to be suffering with prostate cancer each year.

(6/16/07)- The results of a recent large study that included 28,243 men, 55 to 74 years of age, concluded that lycopene is not a protective against prostate cancer. Lycopene is a chemical that is found in tomatoes and other red fruits.

The researchers measured blood concentrations of lycopene, beta corotene, lutein and other carotenoid in 692 randomly selected men in the sample who later develop prostate cancer, and 844 men who did not. The scientists found no link between prostate cancer and blood concentrations of lycopene or other carotenoids, except that men with the highest levels of beta-carotene were somewhat more likely to suffer from an aggressive form of the disease.

Richard B. Hayes, a senior investigator for the National Cancer Institute co-authored the paper, with the results appearing in the May issue of Cancer Epidemioloy Biomarkers & Prevention..

(4/10/07)- An advisory panel to the FDA voted 13 to 4 to approve Provenge, a therapy developed by Dendreon, a Seattle biotechnology company for the treatment of advance prostate cancer. The vote increases the likelihood that the agency will approve the therapy by its May 2007 deadline.

The panel also voted 17 to 0 that the therapy was safe. The negative side effects included fever and chills, though there were some signs that it could increase the risk of stroke. Please keep in mind that there were only 127 patients in the study group. A second trial, done on even a smaller group, showed a survival advantage of 3.3 months versus the 4.5-month survival rate in this study.

Provenge is a personalized therapy in which some of a patient's white blood cells are removed, processed by Dendreon, then infused back into thee body three or four days later. The process hopes to harness the immune system to fight the disease after it develops.

The men in the study had prostate cancer that had spread to other parts of the body. About 50,000 men in the U.S. are in this category, and they generally survive only a year or two.

In its main trial, Provenge extended median survival by 4.5 months- 25.9 months for the treated patients versus 21.4 months for those receiving only the placebo. After three years, 34% of patients who got Provenge were alive compared to 11% of those who got the placebo.

The therapy did not stop the advance of the disease.

(6/09/05)- According to researchers at the Brigham and Women's Hospital and Harvard Medical School a protein test called alpha-methylacyl-CoAracemase seems to be able to predict which men will have their prostate cancer come back after surgery of even which men will die of the disease. The test has been used to help diagnose prostate cancer in hard-to-read tumor biopsies. Dr. Mark Rubin was the lead researcher and spokesman for the study.

The results of the study appear in the June issue of Cancer, Epidemiolgy, Biomarkers & Prevention. The test will show therefore which prostate cancer patients require more aggressive treatment.

(5/13/05)- A small research study involving 767 Connecticut men between the ages of 55 to 74, that was led by Dr. Peter C. Albertson of the University of Connecticut concluded that aggressive treatment for low-grade localized prostate cancer was unnecessary. The results of the study were published in The Journal of the American Medical Association.

The patients involved in the study had been diagnosed between 1971 and 1984 with prostate cancer that had not spread beyond the prostate. Each subject was followed for 10 to 20 years. Some received hormone therapy to halt the body's production of testosterone, which fuels prostate cancer, while other underwent a "watchful waiting" treatment.

Prostate cancer ended up killing 228 of the men, mostly within 15 years of the diagnosis. Most of those who died of the disease had high-grade tumors. The vast majority of the men either died of other causes or survived.

(2/5/05)-For the first time, cancer has replaced heart disease as the number one killer of Americans younger than 85 years of age according to a statistical report that was issued from the American Cancer Society. In 2002, the most recent year for which this data is available, 476,009 Americans in that age category died from cancer, compared with 450,637 who died from heart disease.

According to Dr. Eric Feuer, chief of statistical research for the National Cancer Institute, people younger than 85 account for 98.4 percent of the population. Dr. Feuer was the head statistician for the project. The report found that one of the biggest reasons for the drop in deaths from both causes was that fewer people were smokers.

Between 1965 and 2000, the number of Americans who were smokers dropped from 42% to 22%. The report went on to state that one third of all cancers were related to smoking. Another one third of cancers are related to obesity, poor diet and lack of exercise. Incidentally these same factors contribute to heart disease also.

There is some good news in connection with the battle against cancer. Cancer deaths have declined about 1 percent each year since 1996. With that said, there will be estimated 1,372,910 new cancer cases discovered this year. Of that number, it is estimated that there will be 570,260 cancer deaths. The five-year survival rate has risen to 74 percent from the 50 percent mark of the 1970's.

Lung cancer is the number one killer among cancer victims, with it claiming about 163,500 victims this year. Prostate cancer will be diagnosed in about 232,000 men this year, and it will kill about 30,350 of them. Breast cancer will be diagnosed in about 211,200 women, and it will kill about 40,410 in 2005.

(3/19/03)-GlaxoSmithKline PLC announced that the early results of a study of its new drug Avodart for the treatiment of enlarged prostates that it has conducted on about 4,000 men for a 27 month period of time is quite encouraging. Glaxo launched the drug in the U.S., England and Switzerland earlier this year for the treatment of benign prostate hyperplasia (BPH). Merck & Co.'s Proscar, which was approved in the U.S. in 1993, is currently the biggest selling drug for this problem.

Glaxo said that patients who took the drug over a 27-month period of time had a 50% decrease in reporting rates of prostate cancer compared with patients who were given a placebo. Guy Yeoman, Glaxo's European medical director of urology said that initial data on the drug's ability to fight prostate cancer would be available in about 3 years. PBH is a progressive disease in which the prostate gland surrounding the urethra enlarges which in turn causes urinary difficulty.

The National Cancer Institute, in Bethesda, Md. is conducting a seven-year trial involving 18,000 patients to see whether Proscar reduces the incidence of prostate cancer in men over 55 years of age. Both Avodart and Proscar work by reducing the production of dihydrotestosterone, or DHT, a hormone that causes the prostate to grow. Proscar works by inhibiting one enzyme involved in the production of DHT, Avodart inhibits two.

Predicting survival after prostate surgery has been a long sought after discovery amongst cancer researchers. An article in the May 5th, 1999 Journal of the American Medical Association reports that it may now be possible to predict it. A study group headed by Dr. Patrick Walsh, chief of urology at Johns Hopkins University announced their findings in the article.

The researchers found that there are three characteristics that are the keys in predicting who will have the best chance to survive after prostate surgery. Thus the medical community will have a better understanding as to the type of post- prostate surgery treatment needed on an individualized basis.

Once the prostate has been removed through surgery, the PSA level should be at zero. If the PSA re-appears post surgery it means that the cancer has recurred somewhere in the body. The re-appearance of PSA in the blood post-surgery occurs in about 1/3rd of the cases. Last year about 100,000 men had prostate surgery.

The three characteristics that the researchers found were the keys in predicting which men were the most likely to have the cancer re-appear are as follows:

The men with the highest risk were those with a high Gleason score, a rise of PSA within 2 years after surgery and a doubling of the antigen in less than 10 months. Of the study group of 304 men who had prostate surgery from 1982 to 1997 only 34 % developed the metastic disease. In about half of the cases, the metastases took 8 or more years to occur. In those cases where the spreading did occur the patients were still alive 5 years later.


By Allan Rubin
updated June 3, 2014

See our other articles on Prostate Cancer-Part I
Prostate Specific Antigen (PSA) - Part III
Prostate Specific Antigen- Part IIIa
Prostatitis -Part IV
Justice Ruth Bader Ginsburg and Colon Cancer- Part V
New Drugs in the Battle Against Prostate Cancer -Part VII

To e-mail: hrubin12@nyc.rr or

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