INSIDE THIS ISSUE 1 Break from ADT Lowers Survival Odds Enzalutamide (MDV3100) is a Game Changer 2 in Prostate Cancer 3 Untreated Prostate Cancer Responds to Zytiga Postprostatectomy Test Identifies Risk for 4 Clinical Recurrence Classifying Prostate Cancer by Quantitative 5 Histomorphometry Prostate Cancer Screening Can Be Difference 6 Between Life and Death for Some Pelvic Lymph Node Dissection in Prostate 7 Cancer: Frequency and Nodal Distribution 8 Ginseng Seems to Ease Cancer-Related Fatigue Doc Moyad’s “No Bogus Science” Column – 9 “You Want a Real Cheap Anti-Aging Secret?” 10 Doctor Chodak’s Bottom Line 11 OGX-427 Improves Progression-Free Survival JULY 2012 BREAK FROM PROSTATE THERAPY ENZALUTAMIDE IS A GAME UNTREATED PROSTATE CANCER LOWERS SURVIVAL ODDS CHANGER IN PROSTATE CANCER RESPONDS TO ZYTIGA Interrupting androgen blockade in men A first-in-class drug, the androgen- Men with metastatic castration-resistant with hormone-sensitive metastatic pros- receptor signaling inhibitor enzalutamide prostate cancer (CRPC) had significant tate cancer could shorten their lives. In a (MDV3100), has shown a survival ben- improvement in radiographic progres- long-running clinical trial, survival efit in men with postdocetaxel prostate sion-free survival (rPFS) when treated among men given intermittent androgen cancer. The risk for death decreased by with abiraterone before chemotherapy, a deprivation (IADT) was inferior to sur- 37% vs. placebo, extending survival by randomized clinical trial showed. After vival in men treated continuously, ac- more than 4 months, according to find- a median follow-up of almost 2 years, cording to Maha Hussain, MD, of the ings from the phase 3 AFFIRM study. median radiographically assessed rPFS University of Michigan Comprehensive Neal Shore, MD, from the Carolina Uro- was 8.3 months with placebo, whereas Cancer Center in Ann Arbor, MI. More- logic Research Center, in Myrtle Beach, the median had yet to be reached in the over, the survival inferiority was most SC, and colleagues presented the find- abiraterone (Zytiga) group. The results marked among men with less wide- ings in an oral podium poster session at suggested an overall survival (OS) bene- spread disease – the very patients most the American Urological Association fit with abiraterone, but the data failed likely to be offered IADT, Hussain told (AUA) 2012 Annual Scientific Meeting. to meet the prespecified definition of reporters at the annual meeting of the According to the researchers, enzalu- statistical significance, as reported at the American Society of Clinical Oncology. tamide competitively inhibits the bind- 2012 American Society of Clinical On- “Continuous therapy continues to be the ing of androgens to the androgen recep- cology (ASCO) meeting. standard of care,” she said. tor. It also inhibits androgen receptor “The point estimates for overall survival nuclear translocation and the association Despite that, IADT is widely used in the favored abiraterone in all patient sub- of the receptor with DNA. Enzalutamide US, commented Bruce Roth, MD, of groups,” said Charles J. Ryan, MD, of Washington University School of Medi- displayed activity during phase 1 and 2 trials in pre- and postchemotherapy pa- the University of California San Fran- cine in St. Louis, who was not part of the cisco. “We observed statistically signifi- study but who moderated a media con- tients with progressive castration- resistant prostate cancer (CRPC). cant improvement in all secondary end- ference at which details were presented. points,” he added. That’s because the available evidence In this double-blind placebo-controlled seemed to show the two approaches had multinational study, researchers ran- In contrast to traditional hormonal thera- the same efficacy, he said. “Doctors did- domized patients with CRPC who had pies for advanced prostate cancer, abi- n’t have any specific reason (for men) received at least 1 regimen of docetaxel- raterone disrupts androgen biosynthesis not to come off therapy,” he said. “It based chemotherapy to enzalutamide by inhibiting CYP17 lyase, a key en- looked like survival was equivalent.” 160 mg/day or placebo (2:1 ratio). Pa- zyme in the steroidogenic pathway. Treatment with the drug improved over- “If you can give less treatment while tients were stratified according to base- all survival in patients with metastatic maintaining or improving efficacy and line Eastern Cooperative Oncology CRPC that had progressed after chemo- potentially improving the side-effect Group (ECOG) performance status and Brief Pain Inventory scores. (Continued on page 4) (Continued on page 4) (Continued on page 3) PAGE 2 PROSTATE CANCER HELPLINE - CALL 1-800-808-7866 OR WWW.USTOO .ORG THIS ISSUE OF THE US TOO P ROSTATE CANCER POSTPROSTATECTOMY TEST CLASSIFYING PROSTATE CANCER HOT SHEET IS MADE POSSIBLE BY CHARITABLE CONTRIBUTIONS FROM IDENTIFIES RISK FOR CLINICAL MALIGNANCY BY QUANTITATIVE RECURRENCE HISTOMORPHOMETRY A newly available diagnostic test that Loeffler M, Greulich L, Scheibe P, et al uses immuno-polymerase chain reaction J Urol 187: 1867-75, 2012 (IPCR) technology can detect serum Purpose: Prostate cancer is routinely PSA at concentrations in picograms per graded according to the Gleason grading mL in men after radical prostatectomy scheme. This scheme is predominantly (RP) to help identify men at a low risk based on the textural appearance of aber- of clinical recurrence. Jonathan E. rant glandular structures. Gleason grade AND PEOPLE LIKE YOU! McDermed, PharmD, Director of Scien- is difficult to standardize and often leads ITEMS CONTAINED IN US TOO PUBLICATIONS ARE tific and Clinical Affairs at Iris Molecu- to discussion due to inter-rater and intra- OBTAINED FROM VARIOUS NEWS SOURCES AND lar Diagnostics in Carlsbad, CA, and rater disagreement. Thus, we investigat- EDITED FOR INCLUSION . W HERE AVAILABLE , A colleagues conducted a study using this POINT -OF -CONTACT IS PROVIDED . ed whether digital image based automat- test. The results were published in the REFERENCES TO PERSONS , COMPANIES , PRODUCTS ed quantitative histomorphometry could OR SERVICES ARE PROVIDED FOR INFORMATION April issue of Clinical Chemistry ( Clin be used to achieve a more standardized, ONLY AND ARE NOT ENDORSEMENTS . R EADERS Chem 58: 732-40, 2012). reproducible classification outcome. SHOULD CONDUCT THEIR OWN RESEARCH INTO ANY PERSON , COMPANY , PRODUCT OR SERVICE , Increasing levels of PSA in men with Materials and methods: In a proof of AND CONSULT WITH THEIR LOVED ONES AND prostate cancer treated by RP can signi- principle study we developed a method PERSONAL PHYSICIAN BEFORE DECIDING ON ANY fy a risk for biochemical recurrence. to evaluate digitized histological images COURSE OF ACTION . According to the researchers, this new of single prostate cancer regions in he- THE INFORMATION AND OPINIONS EXPRESSED IN post-RP prognostic test differs from THIS PUBLICATION ARE NOT RECOMMENDATIONS matoxylin and eosin stained sections. FOR ANY MEDICAL TREATMENT , PRODUCT SER- standard PSA tests because it identifies Preprocessed color images were subject- VICE OR COURSE OF ACTION BY US TOO I NTER- risk for clinical recurrence. This can ed to color deconvolution followed by NATIONAL , I NC ., ITS OFFICERS AND DIRECTORS , help clinicians identify men who might the binarization of obtained hematoxylin OR THE EDITORS OF THIS PUBLICATION . F OR MEDI- be able to avoid follow-up treatment. CAL , LEGAL OR OTHER ADVICE , PLEASE CONSULT related image channels. Highlighted PROFESSIONAL (S) OF YOUR CHOICE . The test, developed using the nucleic neoplastic epithelial gland related ob- HOT SHEET EDITORIAL TEAM : acid detection immunoassay (NADiA) jects were morphometrically assessed by JONATHAN E. M CDERMED , P HARM D platform and sold under the name a classifier based on 2 calculated quanti- JACQUELINE KONIECZKA ProsVue, combines sandwich immuno- tative and objective geometric measures, THOMAS N. K IRK assay technology with quantitative PCR that is, inverse solidity and inverse com- US TOO I NTERNATIONAL STAFF : (qPCR) to quantify very low levels of pactness. The procedure was then ap- THOMAS N. K IRK , P RESIDENT AND CEO plied to the prostate cancer probes of TERRI GIBBONS LIKOWSKI , C HAPTER SVCS PROG PSA. The immunoassay uses 2 monoclo- MGR , T OLL FREE PHONE #: 1-877-978-7866 nal antibodies to capture PSA, and the 125 patients. Each probe was inde- JACQUELINE KONIECZKA , O FFICE MANAGER label antibody is conjugated to a short pendently classified for Gleason grade RYAN MAGUIRE , C OMMUNICATIONS COORD . strand of double-stranded DNA. After 3, 4 or 5 by an experienced pathologist US TOO B OARD OF DIRECTORS : several washing steps, the immuno com- blinded to image analysis outcome. EXECUTIVE COMMITTEE /O FFICERS plex is subjected to qPCR, and the Results: Together inverse compactness KAY LOWMASTER , MSW, LCSW, C HAIRMAN and inverse solidity were adequate dis- DAVID P. H OUCHENS , P HD, V ICE -CHAIRMAN amount of PSA can be determined from JACK D. S HAFF , J R., T REASURER the levels of amplified DNA. criminatory features for a powerful clas- RIDGE TAYLOR , S ECRETARY The assay proved to be robust, with a sifier that distinguished Gleason grade 3 DIRECTORS : limit of quantification of 0.000065 ng/ from grade 4/5 histology. The classifier JERRY HARDY mL (0.65 pg/mL). Imprecision was deter- was robust on sensitivity analysis. JEAN JEFFRIES HOWARD KACZMAREK mined using low (3.8), medium (24.1), Conclusions: Results suggest that quan- DAVID M. L UBAROFF , P HD and high (69.1) pg/mL PSA samples and titative and interpretable measures can JAMES L. R IEDER was 5.2, 9.4, and 10.6%, respectively. be obtained from image based analysis, DEXTER C. R UMSEY III permitting algorithmic differentiation of AMES AMMACK “The analytical characteristics of the J C. H , DDS prostate Gleason grades. The method REV . H AROLD “H AL ” T EUSCHER assay support its use for sensitive and must be validated in a large independent THOMAS N. K IRK , P RESIDENT AND CEO precise measurement of serum PSA,” series of specimens. US TOO INTERNATIONAL , I NC . IS INCORPORATED even at concentrations measured in IN THE STATE OF ILLINOIS AND RECOGNIZED picograms per milliliter, Dr.