CONTACTS 

SUBJECTS
Prostate Cancer Research Pills Preventive Medicine Clinical Study Dr

0403 -
0403 -    ..
0404 - Summary/Objective
0405 -
040501 - Follow up
040502 -
040503 - Millie asked about research for drug trials to treat prostate cancer.
040505 -  ..
040506 - The following three (3) clinical studies sound promising...
040508 -  ..
040509 - Review found...
040510 -
040511 -    1.  Atrasentan...
040512 -
040513 -        Johns Hopkins Medicine
040514 -        Office of Corporate Communications
040515 -        Media Contact: Vanessa Wasta
040516 -        410-955-1287; wastava@jhmi.edu
040517 -        June 5, 2004
040519 -  ..
040520 - June 2004 may be a bit dated???
040522 -         ..
040523 -        PROSTATE CANCER PILL MAY STAVE OFF DISEASE AND EASE PAIN
040524 -
040525 -              http://www.hopkinsmedicine.org/Press_releases/2004/06_05_04.html
040526 -
040527 -        Recent clinical studies led by Johns Hopkins Kimmel Cancer
040528 -        Center researchers have found that a drug called atrasentan
040529 -        reduces the risk by 20 percent that cancer will progress in
040530 -        men with advanced hormone-resistant prostate cancer.  The
040531 -        results are expected to be presented at the 40th Annual
040532 -        American Society of Clinical Oncology (ASCO) meeting on June 5
040533 -        in New Orleans.
040534 -
040535 -        "Treatment options remain limited for patients whose prostate
040536 -        cancer has spread and does not respond to hormone therapy, and
040537 -        some of these men are looking for less toxic alternatives than
040538 -        chemotherapy at this point in their lives," says Michael
040539 -        Carducci, M.D., associate professor at the Johns Hopkins
040540 -        Kimmel Cancer Center. "Atrasentan can help prevent their pain
040541 -        and may potentially postpone when they need more aggressive
040542 -        treatments like chemotherapy or radiation."
040544 -         ..
040545 -        Combined results of phase II and phase III international
040546 -        clinical trials, which spanned three years and enrolled  more
040547 -        than 1,000 men, showed an approximately 20 percent decrease in
040548 -        the chance that cancer will progress in those who took
040549 -        atrasentan daily versus a placebo.
040550 -
040551 -        "This drug's largest effect may be its ability to stabilize
040552 -        the progression of prostate cancer to the bone," says
040553 -        Carducci. "As a result, atrasentan slows the rise in PSA
040554 -        levels and delays the development of pain while maintaining
040555 -        quality of life." Few patients experienced side effects such
040556 -        as a stuffy nose, headache, and swelling.
040558 -         ..
040559 -        Part of a new trend in cancer treatment, known as "targeted
040560 -        therapy," atrasentan blocks a protein called endothelin, which
040561 -        is secreted in excess amounts by prostate cancer cells.
040562 -        Endothelin promotes cancer cell growth and stimulates new bone
040563 -        formation where prostate cancer cells have spread to bone
040564 -        sites.  Recent studies elsewhere confirm that endothelin is a
040565 -        key protein involved in the type of bone metastasis that
040566 -        commonly occurs in prostate cancer.
040568 -         ..
040569 -        The phase II trial enrolling 244 patients with metastatic
040570 -        hormone refractory prostate cancer was completed in 2001, and
040571 -        showed atrasentan delayed disease progression by 52 percent as
040572 -        compared to men receiving a placebo. Analysis of the phase III
040573 -        data alone did not show a difference in disease progression
040574 -        between the 804 patients randomized to receive atrasentan or
040575 -        the placebo. But when combined with the results of the Phase
040576 -        II study, investigators observed a statistically significant
040577 -        difference between the drug and its control in the length of
040578 -        time it took for the disease to progress. Both randomized,
040579 -        double-blind studies were similar in design and enrolled
040580 -        patients with hormone resistant prostate cancer that had
040581 -        metastasized or spread.
040583 -         ..
040584 -        Carducci plans to continue studies of atrasentan in patients
040585 -        whose cancer has not spread and in combination with other
040586 -        drugs that block growth factors.  He adds that atrasentan
040587 -        could potentially be an option after second-line hormonal
040588 -        therapy or when patients are waiting to begin chemotherapy.
040589 -        Johns Hopkins and other centers nationwide will study the drug
040590 -        in patients with brain, renal cell, ovarian and lung cancers.
040592 -  ..
040593 - This sounds promising.
040595 -  ..
040596 - Research continues...
040597 -
040598 -        The identification of endothelin and its role in prostate
040599 -        cancer as a potential target for therapy led to the
040600 -        development of atrasentan and was first described nine years
040601 -        ago in Johns Hopkins laboratories through a specialized
040602 -        program of research excellence (SPORE) grant from the National
040603 -        Cancer Institute.
040605 -         ..
040606 -        Co-authors are Joel B. Nelson from the University of
040607 -        Pittsburgh, F. Saad from University of Montreal, Canada; C.C.
040608 -        Schulman from Erasme Hospital, Brussels, Belgium; D.P.
040609 -        Dearnaley from Royal Marsden Hospital, London; D.J. Sleep,
040610 -        S.M. Hulting, J.D. Isaacson, A.R. Allen, and P. Nisen from
040611 -        Abbott Laboratories.
040613 -         ..
040614 -        This study was funded by Abbott Laboratories.
040616 -         ..
040617 -        Carducci is a consultant to Abbott Laboratories.  The terms of
040618 -        this arrangement are being managed by the Johns Hopkins
040619 -        University in accordance with its conflict of interest
040620 -        policies.
040621 -
040623 -         ..
040624 -    2.  SELECT -- "Selenium and Vitamin E Cancer Prevention Trial."
040626 -         ..
040627 -        Cancer Care Foundation
040629 -         ..
040630 -        Volunteers Sought for Vitamin E, Selenium Study In Largest-Ever
040631 -        Prostate Cancer Trial
040632 -
040633 -              http://www.cancure.org/clinical_trials.htm
040635 -         ..
040636 -        Health locations across the United States, Puerto Rico and
040637 -        Canada are putting out calls for male volunteers to take part
040638 -        in what is termed "the largest prostate cancer prevention trial
040639 -        that's ever been performed," a study of the roles of Vitamin E
040640 -        and selenium as antioxidants that help control cell damage
040641 -        leading to prostate cancer.
040643 -         ..
040644 -        The study is being conducted by the National Cancer Institute,
040645 -        part of the National Institutes of Health (NIH) in Bethesda,
040646 -        Md.  It is called SELECT, for "Selenium and Vitamin E Cancer
040647 -        Prevention Trial." Previous studies have shown that natural
040648 -        Vitamin E can reduce prostate cancer by as much as 32 percent,
040649 -        and selenium, in its natural mineral form, has also been
040650 -        demonstrated to reduce prostate cancer in male participants.
040652 -         ..
040653 -        Some 400 U.S. locations are recruiting 32,400 men for the
040654 -        12-year study.  Go to...
040655 -
040656 -              http://cancertrials.nci.nih.gov/types/prostate/select/
040657 -
040658 -        ....for information on this.  Those who are interested in the
040659 -        possibility of joining the SELECT trial should contact the
040660 -        NCI's Cancer Information Service at 800-422-6237 or
040661 -        800-332-8615.  To be eligible for the SELECT trial,
040662 -        participants must have a DRE that indicates no signs of
040663 -        prostate cancer and a total PSA level less than or equal to 4.0
040664 -        ng/ml
040665 -
040667 -  ..
040668 - This may not apply to someone who has been treated for prostate
040669 - cancer.
040670 -
040671 -
040672 -    3.  Dutasteride
040673 -
040674 -        Two New Clinical Trials:
040675 -        Prevention of Prostate Cancer,
040676 -        Osteoporosis in Men Under Study
040677 -
040678 -              http://psa-rising.com/med/info/prev_osteotrialmcg.htm
040679 -
040681 -         ..
040682 -        By Toni Baker
040683 -        Oct. 20, 2004;
040684 -        edited by J. Strax Oct. 27, 2004
040686 -         ..
040687 -        Preventing prostate cancer and helping men in treatment for
040688 -        prostate cancer to avoid osteoporosis is the focus of two new
040689 -        clinical trials at the Medical College of Georgia (MCG).
040691 -         ..
040692 -        The cancer prevention study examines the potential of
040693 -        dutasteride, the active ingredient in a drug marketed to treat
040694 -        prostate enlargement, a common problem of aging.
040696 -         ..
040697 -        MCG is evaluating patients age 50-75 with elevated PSAs, a
040698 -        marker for prostate cancer, who have had a negative biopsy in
040699 -        the last six months.  The study runs for four years and
040700 -        participants will receive additional biopsies at years two and
040701 -        four.
040703 -         ..
040704 -        The osteoporosis prevention study looks at the bone-thinning
040705 -        disease often associated with menopausal women.  Loss of the
040706 -        female hormone, estrogen, helps disrupt the normal balance
040707 -        between cells called osteoblasts that make bone and osteoclasts
040708 -        that consume it.
040710 -         ..
040711 -        Some details about this trial can be read online under the
040712 -        title Calcium With or Without Estrogen and/or Risedronate in
040713 -        Preventing Osteoporosis in Patients with Prostate Cancer.
040715 -         ..
040716 -        Another Phase III randomized trial for osteoporisis prevention
040717 -        is recruiting at Herbert Irving Comprehensive Cancer Center at
040718 -        Columbia University, New York,  New York,  10032:Zoledronate
040719 -        and Estradiol in Preventing Bone Loss in Patients With
040720 -        Prostate Cancer
040722 -         ..
040723 -        While men also naturally experience a decline in their
040724 -        testosterone level with age, they keep making the hormone
040725 -        throughout life and tend to start out with denser bones than
040726 -        women, unless they get prostate cancer and receive hormonal
040727 -        blockade for the disease.
040729 -         ..
040730 -        But prostate cancer, much like breast cancer, is a
040731 -        hormone-dependent cancer, If surgery, brachytherapy or
040732 -        external beam radiotherapy fail or if the disease is found too
040733 -        late for curative treatment, a mainstay of treatment of
040734 -        advanced disease is hormone blockade.
040735 -
040736 -        "Testicles make male hormone," says Dr. Brown. "The prostate
040737 -        gland is a sex organ that responds to male hormone. This gland
040738 -        develops at puberty, with the influx of hormones, but it will
040739 -        often continue to grow throughout life, which is why sometimes
040740 -        with age, men have problems with an enlarged prostate.
040741 -        Prostate cancer also will grow more rapidly and aggressively
040742 -        with male hormone circulating."
040744 -         ..
040745 -        Faced with a need to halt testosterone production, most men
040746 -        today shun surgical removal of the testicles (orchiectomy) and
040747 -        prefer to take one or more drugs that suppress hormone
040748 -        production.  Intermittent use of hormonal blockade is becoming
040749 -        more widespread.  Even so, these drugs take a toll on general
040750 -        health including bone density.
040751 -
040752 -        "The mainstay of prostate cancer therapy is anti-hormone
040753 -        therapy and men typically are on it for years," says Dr.
040754 -        Brown. Side effects often include markedly reduced libido as
040755 -        well as the increased risk of osteoporosis.
040757 -         ..
040758 -        The study looks as a new bisphosphonate, called risedronate,
040759 -        that may slow bone resorption and may help correct the bone
040760 -        deficit that occurs with anti-hormone therapy, Dr. Brown says.
040761 -        For this study, MCG is looking for men with prostate cancer
040762 -        who are taking anti-hormone therapy for their disease.
040763 -        Participants will be followed for two years; half will receive
040764 -        the study drug and half will receive placebo. MCG expects to
040765 -        enroll about 20 patients in the study that will follow 1,200
040766 -        men nationally.
040768 -         ..
040769 -        A Phase III trial that gives half the patients a placebo (a
040770 -        sugar pill or fake drug) puts you at risk 50/50 of going
040771 -        without a treatment you may need. Can you get an already
040772 -        tested, good-enough version of the drug without entering the
040773 -        trial?
040775 -         ..
040776 -        If you already have early signs of weak bones, you may need to
040777 -        start taking a medication now.  Men taking hormonal blockade
040778 -        for prostate cancer are advised to get a baseline bone density
040779 -        scan and to start taking preventive medication such as Fosamax,
040780 -        Aredia or Zometa.  Test have shown that hormonal treatment
040781 -        starts to weaken bone inmonths.
040783 -         ..
040784 -        The 2 trials in the box above give patients a chance to take
040785 -        estrogen or estradiol along with calcium.  These types of
040786 -        hormonal therapy may protect bones.  Both these drugs are
040787 -        available on prescription.  Some oncologists already prescribe
040788 -        them for prostate cancer patients in place of Lupron/Zoladex or
040789 -        after those drugs fail.
040791 -         ..
040792 -        For more information about the studies contact Mary Anne Park,
040793 -        director of the MCG Surgical Research Service, at 706-721-0193
040794 -        or check the NCI listings.
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