Predicting Survival after Prostate Surgery-Part II of a VI Part Article
(9/28/11)- The results of a study which was published in a recent edition of The Journal of the American Medical Association, that evaluated sexual function among more than 1,000 men at nine academic medical centers indicated that all 3 possible treatments used left a high percentage of males unable to have a normal sex life.
The senior author of the study was Dr. Martin G. Sanda, a co-director of the prostate cancer program at the Dana-Farber/ Harvard Cancer Center.
The study evaluated the sexual function of men who had undergone: surgical removal of the prostate; radiation therapy; or brachytherapy, which uses radioactive seed implants.
Just 35% of men in the surgery group, 37% in the radiation group and 43 % in the brachytherapy group were able to have sexual intercourse two years after treatment. The study followed the patients for only two years after their various procedures.
In all three groups, the quality of a man's erections before treatment, determined using a questionnaire about his sex life, helped predict his sexual recovery. Variables including age and the extent of the cancer were also important factors in determining the effect of the procedure on subsequent sex ability.
(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.
(7/4/11)- Each year, about 218,000 men are diagnosed with prostate cancer, and almost 32,000 men die of the disease. If the cancer has spread from the prostate, victims are given drugs that suppress the body's production of the hormone testosterone, which can fuel the tumor's growth. Incidentally, in the case of women with breast cancer, hormonal inhibitor drugs such as fermera are administered to hold back the production of estrogen, which fuels the growth of the cancer cells.
We discussed in our item dated 6/8/11 below the 3 new drugs that have been approved by the FDA to treat advanced prostate cancer, in addition to docetxel which was approved in 2004.
The new drugs add about 2 to 5 months to median survival when tested in clinical trials. Medical experts estimate that men taking more than one of the drugs in succession could be expected to live more than two years.
Provenge costs more than $93,000 for the course of treatments, while Zytgia costs about $5,000 a month, and Jevtana, costs about $8,000 every 3 weeks.
(6/8/11)- There are now 3 drugs available to treat advanced prostate cancer. They are Dendreon Corp.'s Provenge, Sanofi SA's Jevtana and J& J's Zytiga.
Bayer AG announced that it expected its Alphararadin to become the 4th drug available in this battle. According to Morningstar Inc the worldwide market for prostate-cancer therapies is about $1billion.
Alpharadin, or radium-223 chloride specifically targets cancer that has spread to the bone. The Bayer study involves 922-patients in a randomized study, with a goal of improving survival time for patients taking its drug. The study was halted so that patients taking the placebo were put on the drug when it was found that the median survival was 14 months for those on the drug versus 11.2 months for those on the placebo.
Both groups were also given standard chemotherapy. Complete data from the study will be presented at an upcoming scientific meeting. In the pipeline, Medivation Inc. has a drug in late-stage development and Exelixis Inc reported promising results from a midstage,or Phasse !!, study of its drug cabozantinib, in advanced prostate cancer. As a note of caution, six deaths related to the drug were reported in a separate trial.
New data from the ongoing Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) appearing in the May 5 issue of the New England Journal of Medicine suggests that radical prostatectomy appears to be a wise choice for men with early-stage prostate cancer who are younger than 65 years.
The data, from a Swedish randomized clinical trial, compares surgery with "watchful waiting."
The study shows that, at 15 years, the cumulative incidence of death from prostate cancer was 14.6% among 347 men randomized to prostatectomy and 20.7% among 348 men being observed without treatment.
A Food and Drug Administration (FDA) advisory panel turned down a request by GlaxoSmithKline PLC to allow the company to add to the label of its prostate drug dutasteride, which is marketed as Avodart, that is can reduce the risk of getting prostate cancer. Merck had also attended the meeting at the request of the panel because its prostate drug finsteride, a generic that is sold as Proscar, was being tested as a prostate-preventing drug.
Both of the drugs made by the two companies are approved for sale as prostate shrinking medications.
The Glaxo study of its drug involved 8,000 men at risk for prostate cancer because their PSA tests had found high levels of elevation of that blood protein. The men also had prostate biopsies, but at the start of the study none had received a diagnosis of prostate cancer.
The Merck-finasteride study was sponsored by the National Cancer Institute, and included 18.800 healthy men over age 55 who were randomly assigned to take the drug or a placebo.
Both studies found that the drugs reduced the overall prostate cancer risk by about 25%. Both studies however found small increases in the incidences of higher-grade, riskier cancers in men taking the drugs as compared with placebos.
The companies and their researchers explained that in reducing the size of the prostate, it made it easier to find lethal cancers in the biopsies.
The advisory panel also found that there was too much uncertainty about long-term consequences from prolonged usage of the drugs.
(6/22/10)- The FDA approved Sanofi-Aventis SA's chemotherapy drug Jevtana, used in combination with the steroid predmisone to treat men with advanced prostate cancer.
Jevtana's safety and effectiveness was established in a single 755-patient study. The approval from the FDA came from the priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment.This particular study was acted on after only 3 months.
The study was designed to measure overall survival, or the length of time before death, in men who received Jevtana in combination with the steroid, compared with whose who received the chemotherapy drug, mixtoantrone, in combination with the steroid.
The median survival rate was 15.1 months, compared with 12.7 months for those who received the mitoxantrone regimen, according to the FDA
(6/23/09)- Men who use statins may be at lower risk for prostate cancer, according to an industry-supported study presented at the annual meeting of the American Urological Association.
Researchers in Minnesota enrolled some 2400 men between the ages of 40 and 79 and without histories of prostate cancer.
About one fourth were using statins at baseline. During 14 years' follow-ups, prostate cancer was diagnosed in 5% of statin users — corresponding to a 60% risk reduction compared with those not using the drugs.
Statin users were also less likely to have elevated prostate-specific antigen levels or to undergo prostate biopsy.
(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.
(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.
(4/04)-Only 13% of the 250,000 men in the U.S. who are diagnosed with prostate cancer will die from it. It is however the second leading cause of death among men who die from cancer. Only lung cancer causes more deaths for male Americans. Prostate cancer is the cause of death for 3% of the U.S. male population.
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.
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "Selecting a Nursing Home"
See our earlier articles on Prostate
Cancer- Part I-General Information
Prostate Specific Antigen (PSA)- Part III
Prostate Specific Antigen- Part IIIa
Prostatitis -Part IV
Prostate Cancer-Colon Cancer- An Overview
- Part V
Also please see: Justice Ruth Bader Ginsburg
and Colon Cancer
By Allan Rubin
updated September 28, 2011
To e-mail: hrubin12@nyc.rr.com
or rubin@brainlink.com