New Drugs in the Battle Against Prostate Cancer-Part VII of a VI I Part Article on Prostate Cancer

(6/29/21)- A promising new treatment for men with aggressive prostate cancer is giving some hope to those afflicted with the disease. The investigational treatment called lutetium 177-PSMA. 617 showed a nearly a 40% reduction in deaths over the course of the trial, compared with similar men who received only the standard treatment.

The study followed 831 patients with the advanced disease in 10 countries for a median period of 20 months.

Dr .Oliver Sartyor, the medical director at Tulane Cancer Center in New Orleans, along with Dr. Bernard Krause of Rostock Medical Center in Germany were the lead authors of the study. which was sponsored by Endocyte Inc. and Advanced Accelerator Applications, which are Novartis Company subsidiaries. Dr. Sartor is a paid consultant to the company. The data was analyzed by the company and provided confidentiality to the authors.

(3/22/17)- A new, more intensive radiation treatment for prostate cancer is gaining increased usage, even though there have not been any long term studies as to its results. Under this new procedure, five radiation sessions are administered over two weeks instead of 10 sessions over about 2 months, or 28 sessions over 5 to 6 weeks.

This new type of treatment is called stereotactic body radiation therapy or S.B.R.T. The most recent data only covers the year 2013, when 1,886 men received this type of treatment for prostate cancer, with 47,512 getting the standard radiation therapy that year, according to Medicare data.

The National Cancer Institute will fund an 8 year study of this new procedure, not only as to its effectiveness, but also to determine if there any negatives to it.

(2/4/14)- In a study of 1,717 men in various countries with cancer that had spread beyond the prostate and was no longer responding to therapy aimed at suppressing testosterone, which speeds about the growth of the cancer, it was determined that the median survival period for men who received the drug Xtandi was 32.4 months versus the 30.2 month median survival time for those who took a placebo.

Xtandi, also known as enzalultamide, was developed by Medivation and Astellas Pharmaceutical, which were the companies that sponsored the study. The clinical trial for the drug started in September 2010 and had been expected to last until September 2014, but the drug was so effective that the trial was stopped in October.

Xtandi was approved by the FDA in 2012 as a treatment for men with metastatic prostate cancer who already had tried the chemotherapy drug docetaxel. The new study showed the drug was effective when tried before chemotherapy. Johnson & Johnsonís blockbuster drug Zytiga would be the main competitor for this area of cancer treatment

(9/1/13)- At least 3 major medical insurers have recently decided to stop covering proton beam therapy for early stage prostate cancer treatment, asserting that while the treatment is effective, it is much less cost effective than some of the other comparable treatments.

Medicare pays more than $32,000 for the procedure, while more conventional radiation options cost about $19,000.

Proponents of the proton beam process assert that its precision spares healthy tissue, and that this methodology reduces significant side effects associated with other radiation treatments.

Blue Shield of California recently sent letters to about 300 radiation oncology and urology specialists in the state advising them that beginning at the end of October it will no longer cover this type of prostate cancer treatment for patients with early stage prostate cancer. Aetna Inc., the 3 largest U.S. insurer previously stopped coverage of this type of treatment on August 1.

Wellpoint Inc., is continuing to cover the treatment while it negotiates the cost of the procedure. More than 200,000 American men are diagnosed with the disease each year. Approximately 28,000 men die from the disease, while the cost of treating those afflicted with the disease runs into the billions of dollars mark.

(12/20/12)- About 242,000 men are diagnosed with prostate cancer each year in the U.S., and about 28,000 men die in this country from the disease. Recently advocates of proton-beam therapy have asserted that it is a better way to treat the disease than is the traditional radiation therapy method.

Proton radiotherapy uses atomic particles to treat the cancer, with the claim being made that it is a more exact method of treating the disease than is regular radiation therapy. It does require however a particle accelerator that is extremely large in size and costs about $180 million.

There are presently 10 such accelerators in the U.S., and nine more are in development.

Medicare pays about $32,000 per patient for proton therapy versus the $19,000 that it pays for the traditional radiation procedure.

Researchers at the Yale School of Medicine examined Medicare records of over 30,000 men aged 66 and over who had either proton therapy or intensity-modulated radiotherapy (IMRT) in 2i008 and 2009. They concluded from their research that the proton-beam therapy provided no longer-term benefit over traditional radiation despite the greater cost.

There was no difference between the two methods of treatment in the rate of other common side effects.

(3/11/12)- Johnson & Johnson's prostate cancer drug Zytiga was approved in April for use in men with advanced levels of the disease who had already undergone chemotherapy using the drug docetaxel. The company announced last week that the drug was also clinically effective when used before chemotherapy.

In a trial of 1,088 men whose cancer had spread beyond the prostate, and was no longer being controlled by hormone-deprivation therapy, Zytiga was clinically effective in prolonging the lives of men who had not yet undergone chemotherapy.

An independent committee monitoring the trial concluded that it would be unethical to continue the trial because the positive results for the trial group receiving the drug should be extended to the placebo group that was not receiving the drug.

Men who received Zytgia went significantly longer before their disease progressed than those who received the placebo. They also lived longer on average by what the company called a "clinically meaningful" amount of time without stating how much longer this was statisically.

Zytgia costs about $5,000 a month even though it is only a pill.

Dendron's Provenge, which is now used before chemotherapy has been shown to extend survival by about 4 months. A course of treatment using Provenge costs about $93,000.

As we discuss in our item dated 2/14/12 below, MDV3100 from Medivation Inc., and Astellas Pharmaceutical has been shown to extend survival by about 5 months for post-chemotherapy patients

(2/14/12)- Within the last two years, there have been 3 drugs that have gotten Federal Drug Administration approval to be sold in the battle against prostate cancer.

The three drugs are Dendron Inc.'s Provenge, Sanofi SA's Jevtana and Zytiga from Johnson & Johnson. The results of two promising new drugs in the battle against the disease were revealed at the recent meeting of the American Society of Clinical Oncology's Genitourinary Cancer Symposium held in San Francisco.

An experimental drug from the San Francisco based Medivation Inc., called MDV3100 extended survival by nearly 5 months in a 1,199 patient study. This drug was developed in the research laboratory of Charles Sawyers, a scientist at Memorial Sloan-Kettering Cancer Center in New York city.

The company expects to file its application with the FDA this year. It will take at least 5 years of trials with humans however before the drug can be approved by the agency.

A second drug, a radiation-emitter being developed by Bayer AG, and Algeta SA of Norway, which targets prostate cancer that has spread to the bone, improved survival by nearly 3 months in a 922-patient study.

These new drugs are not cures, they only increase the length of survival from the disease, and they are quite expensive. Provenge costs $93,000 for a course of 3 treatments, while Zytiga's price is about $5,00 for a monthly supply of pills.

Prostate Cancer-Part I
Predicting Survival After Prostate Cancer -Part II
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


Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated June 29, 2021

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