Clinical Trials

Christopher Lukas Health Guide
  • In an essay I wrote several weeks ago I discussed the drop-off in volunteers for clinical trials.

    This week, I want to talk more about the trials themselves than about the problem finding volunteers.

    But, first, let me clarify what is meant by the word “volunteer.” Simply put, it means patients with cancers who want to enroll in a clinical trial because they believe they can get more advanced treatment for a cancer that is not susceptible to a current treatment.

    In the case of prostate cancer, there are fewer clinical trials than in many other forms of cancer because
    1) there are three treatments now that seem to work.
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    2) Because prostate cancer is a slow-growing cancer.
    3) Because fewer men have the virulent variety that can’t be treated by current means.
    4) Because more attention has been given, traditionally, to breast cancer and other, fast-moving, deadly cancers.

    Still, it’s worth noting that there are clinical trials trying to get new or better treatments for prostate cancer, especially for Stage III or IV varieties, ones that threaten the bones or other organs, or have caused pain.

    First, let’s talk about clinical trials overall. The material I quote is from the web site of the National Cancer Institute, a government body. They say it all very clearly, so I’m going to use their explanations where I think they do better than I can possibly do.

    What is a trial:
    A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective.

    While there are a variety of kinds of trials (Treatment, screening, Prevention, and Quality of Life trials), Treatment is the one I’ll deal with this week.

    Treatment trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).

    While Phase I and Phase II trials are important (determining how a drug should be given, and whether it’s safe,) the most interesting from your point of view is Phase III, where a drug or other treatment is tested against current procedures or medications.

    Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.

    One of the things patients want to know – if they enroll in a trial – is whether they’ll be getting the new treatment or the old one. Precisely because the efficacy of the trial depends on randomization of patients, you would not be told. So why get involved?

    There are two or three reasons:
    1)Because you are helping a process that could lead to new treatment that could benefit you.
    2)Because you are helping the medical profession benefit others.
    3)Because you need to do something to further your own treatment. (Once again, entering a clinical trial is done only when you and your physicians determine that current treatment(s) aren’t going to protect you against a deterioration of your condition.)

  • So, what kinds of trials are going on now? A full list for prostate cancer can be found at the following address on the Internet:
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    http://www.cancer.gov/search/ResultsClinicalTrials.aspx?protocolsearchid=2461002

    Here is one that is very interesting to me, because it looks at a Stage III cancer, with the hope of ameliorating or stopping its growth.

    Androgens can cause the growth of prostate cancer cells. Androgen suppression may stop the adrenal glands from making androgens. Zoledronate may stop the growth of tumor cells in bone and help relieve some of the symptoms caused by bone metastases. It may also delay or prevent bone metastases in patients with nonmetastatic prostate cancer. Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the blood flow to the tumor. It is not yet known whether giving androgen suppression together with zoledronate, docetaxel, prednisolone, and/or celecoxib is more effective than giving androgen suppression alone in treating prostate cancer.

    This randomized phase II/III trial is studying how well giving androgen suppression together with zoledronate, docetaxel, prednisolone, and/or celecoxib works and compares it to androgen suppression alone in treating patients with locally advanced or metastatic prostate cancer.


    And here’s one that deals with the problems of erectile dysfunction (impotence.)

    Radiation sometimes affects the ability for a person to have a normal erection. Complete loss of erections after radiation treatment can happen in 40-50% of treated patients. There are medications, like Sildenafil (also known as Viagra), can help the ability to get back erections in almost 70% of such patients.

    The purpose of this study is to see if taking Viagra every day starting right before, during and for about 6 months after your treatment, could reduce your risk of long-term erectile dysfunction.


    There are others, and I urge you to look them up.

    Talk about clinical trials in the message boards.
Published On: September 27, 2006