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 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 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. McDermed AS A 501( C)(3) N OT -FOR -PROFIT Get connected to CHARITABLE CORPORATION and colleagues note. According to the other men and DONATIONS / G IFTS TO US TOO A RE researchers, studies investigating the family members TAX DEDUCTIBLE prognostic clinical utility of ProsVue dealing with a 5003 F AIRVIEW AVE . D OWNER ’S GROVE , IL 60515 PSA slope in men after RP are complet- prostate cancer PHONE : (630) 795-1002 / FAX: (630) 795-1602 ed and will be reported separately. diagnosis at: WEBSITE : WWW.USTOO .ORG http:// ustoo. COPYRIGHT 2011, U S TOO I NTERNATIONAL , I NC . (Continued on page 6) inspire.com

US TOO I NTERNATIONAL PROSTATE CANCER EDUCATION & S UPPORT HOT SHEET – JULY 2012 PAGE 3

ENZALUTAMIDE IS A G AME -CHANGER (Continued from page 1) PROSTATE CANCER SCREENING CAN BE DIFFERENCE BETWEEN The study involved 1199 men from 15 more than 800 men had seizures (0.6%). LIFE AND DEATH FOR SOME countries, recruited from September “This is the first once-a-day agent that 2009 to November 2010. About three doesn’t require concomitant steroids, Men of lower socioeconomic status and quarters of the men had received docet- and you can take it with or without those from third world countries are a axel and 37.8% had more than 20 bone meals,” said Dr. Shore. Trials in earlier- subset of patients who do need prostate- lesions. The primary end point was stage disease with this agent are ongo- specific antigen screening, researchers overall survival (OS); secondary end ing. One large multicenter trial will eval- said last week at the 107th Annual Sci- points included radiographic progres- uate this agent in men who have not re- entific Meeting of the American Urolog- sion-free survival, time to first skeletal- ceived docetaxel. There are also plans to ical Association (AUA) in Atlanta, GA. related event (SRE), and time to prostate evaluate it in M0 castrate-resistant pros- That’s because these men often present -specific antigen (PSA) progression. tate cancer and in the androgen-sensitive with advanced, metastatic prostate can- The study was unblinded on the recom- disease state, Dr. Shore said. cer, Dr. Brian K. McNeil, from SUNY mendation of the Independent Data “This is a game-changing agent because Downstate Medical Center, Brooklyn, Monitoring Committee after a planned of its tolerability and, more important, NY, told Reuters Health in an interview. interim analysis at 520 death events its efficacy and ease of administration,” “Considering the recent controversies showed a significant 4.8-month OS ben- he said. “I think this is an exceptionally regarding PSA screening, including the efit for enzalutamide, vs. placebo (18.4 optimistic and exciting time for both recent US Preventive Task Force recom- vs. 13.6 months; hazard ratio, 0.631; P clinicians and patients.” mendation against screening, we decid- < .0001), indicating a 37% reduction in ed to study those patients in our popula- the risk for death. A survival benefit was According to Medivation and Astellas, tion who presented to Downstate with observed across all subgroups. Men in the US FDA has received a New Drug metastatic prostate cancer to identify the enzalutamide group received therapy Application for enzalutamide. “I antici- those who would suffer if PSA screen- for longer than those in the placebo pate that FDA will review the data fa- ing was eliminated,” Dr. McNeil said. group, and more men in the enzalutam- vorably, given the combination of effi- ide group remained on study (28.9% vs. cacy and safety from the AFFIRM clini- He and his team searched a prospective- 4.8%) Dr. Shore pointed out. cal trial,” stated Oliver A. Sartor, MD, ly maintained androgen deprivation from the Departments of Medicine and therapy database from their inner city Overall, enzalutamide was well tolerat- Urology at Tulane University School of ed. There were no differences between hospital and identified 148 men who Medicine in New Orleans, Louisiana, presented with metastatic prostate can- the enzalutamide and placebo groups who was not involved in the trial. with respect to lab abnormalities or car- cer. At presentation, the median age diovascular events. In terms of serious 2012 AUA Annual Scientific Meeting, was 69, and the median Gleason sum adverse events, the only difference was Abstract LBA1, presented 22 May 2012 was 8 on prostate biopsy. Medscape Medical News, 25 May 2012 that in the enzalutamide group, 5 of (Continued on page 8)

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PAGE 4 PROSTATE CANCER HELPLINE - CALL 1-800-808-7866 OR WWW.USTOO .ORG

IADT VS . ADT UNTREATED PROSTATE CANCER RESPONDS TO ZYTIGA (Continued from page 1) (Continued from page 1) profile, that would be a clinically im- therapy (N Engl J Med 2011; 364: 1995- ical progression (20% to 25%), and both portant endpoint,” Hussain said. But the 2005). Abiraterone subsequently re- radiographic and clinical progression results of this controlled study is likely ceived FDA approval for treatment of (10% to 11%). to persuade both doctors and patients metastatic CRPC after progression on When the trial stopped, the placebo arm that sporadic therapy has a dangerous docetaxel (Taxotere®). downside, Roth said. “There is a price to had a median rPFS of 8.3 months and a pay and that price is nearly 2 years of Investigators in 12 countries sought to median OS of 27.2 months, whereas the survival,” he said. address some of the limitations in a mul- median for both endpoints had yet to be ticenter phase III clinical trial of abi- reached in the abiraterone group. The The international randomized trial was raterone in men with metastatic CRPC difference in favor of abiraterone in designed to show that IADT was not not yet treated with docetaxel. They pPFS and OS translated into a 57% and inferior in efficacy to continuous ADT, randomized men to daily abiraterone 25% reduction in the hazard ratios, with an upper bound hazard ratio (HR) of plus prednisone or to placebo plus pred- (P<0.0001 and P=0.0097, respectively). 1.20. To test the issue, they enrolled nisone. Recognizing that death and de- The study revealed no new safety con- 3,040 men with newly diagnosed meta- lay in disease progression can be signifi- static disease and PSA levels of at least 5 cerns, as adverse events were consistent cantly separated in time, investigators ng/mL of blood. They were given ADT with those observed in the phase III trial specified co-primary endpoints of OS for 7 months, using goserelin (Zoladex ®) of post-chemotherapy patients, Ryan and rPFS, Ryan said. and bicalutamide (Casodex ®). Those said. The most common adverse events who showed a response, defined as a Secondary endpoints reflected the time (all grades) were fatigue (39%), fluid PSA ≤4.0 ng/mL in months six and sev- frame of deterioration from asympto- retention (28%), hypertension (22%), en were assigned randomly to continuous matic status to clinical hallmarks of the cardiac disorders (19%), hypokalemia ADT or to have it interrupted. disease process: (17%), and elevated liver enzymes (11% With a median follow-up of 9.2 years, Need for opiate pain relievers to 12%). Grade 3-4 adverse events were Hussain reported, median overall sur- Initiation of chemotherapy uncommon. vival of those in the continuous arm was Deterioration of performance status Invited discussant Susan Halabi, PhD, 5.8 years, compared with 5.1 for those Time to PSA progression of Duke University in Durham, N.C., getting IADT. The difference yielded an Investigators defined rPFS by appear- said that stopping the trial after an inter- HR for death of 1.09 in favor of contin- ance of new lesions on bone scans, de- im analysis introduced confounding uous ADT, but the upper bound of the velopment of soft-tissue lesions on CT factors that will bias follow-up data 95% confidence interval was 1.24, so or MRI, and death from any cause. The analysis. She acknowledged the overall that the investigators could not conclude protocol specified three interim anal- trend favoring abiraterone but empha- that the two were equivalent. yses: one after occurrence of about 15% sized that the OS outcome remains only When the researchers analyzed sub- of OS events, a second after occurrence a trend. The secondary outcomes were groups of patients, they found that of 40% of events, and a third after oc- more solid. IADT offered equivalent survival for currence of 55% of events. Source reference: extensive metastases. But surprisingly, continuous ADT was significantly better The data and safety monitoring commit- 2012 ASCO Annual Meeting, Abstract for minimal metastases, offering a medi- tee recommended stopping the trial after LBA4518 presented 3 June 2012. an survival of 7.1 years versus 5.2 for the second interim analysis, which came MedPage Today, 3 June 2012 IADT (HR 1.23, 95% CI 1.02 to 1.49). after 43% of OS events had occurred This was statistically significant at (P=0.008). Had the trial stopped after P=0.034, Hussain said. 40% of events, statistical significance would have been defined as P=0.0005. “We found this rather striking and sur- The primary analysis included 1,088 Want to learn more about lo- prising, as it goes against conventional men, who had a median age of about 70 belief,” Hussain said. This may indicate cal prostate cancer support that there are other important biological and PSA of about 40 ng/mL. More than group activities? Read the differences between widespread and 80% had bone metastases (>10 lesions more limited metastatic prostate cancer, in half of the men), half of the men had she added. soft-tissue or nodal lesions. Reference: After a median follow up of 22.3 months, 69% of abiraterone group had Hussain M, Tangen CM, Higano CS, et discontinued the drug, as had 84% of the at www.ustoo.org! al. Presented at the 2012 Annual ASCO placebo group. The most common rea- meeting; Abstract 4. sons for discontinuation were radio- MedPage Today, 3 June 2012 graphic progression (20% to 30%), clin-

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PELVIC LYMPH NODE DISSEC- GINSENG CAPSULES SEEM TO EASE CANCER -RELATED FATIGUE TION FOR PROSTATE CANCER : Study found herb worked better than seng treatments would cost. REQUENCY AND ISTRIBUTION F D sham treatment, but only after about OF NODAL METASTASES IN A A previous Mayo Clinic study found 2 months that about one-quarter of patients who’d CONTEMPORARY RADICAL The herb ginseng appeared to signifi- had cancer and suffered from fatigue PROSTATECTOMY SERIES cantly reduce cancer-related fatigue said they felt “moderately better” or Godoy G, von Bodman C, Chade DC, et al compared to an inactive placebo, alt- “much better” after taking 1,000- J Urol 187: 2082-6, 2012 hough it took several weeks for the milligram or 2,000-milligram ginseng herb’s effects to take effect in the pa- tablets. By comparison, only 10 percent Purpose: We determined the frequency tients, a new study reports. of those who took the placebo reported and distribution of metastases to pelvic those results. lymph nodes in a contemporary Ameri- In the study, the researchers gave either can radical prostatectomy series. a placebo or 2,000-milligram capsules Laura Murphy, a professor of physiolo- of ground ginseng root to 340 patients gy at Southern Illinois University Car- Materials and methods: In 642 consec- who were being treated for cancer or bondale who’s familiar with the re- utive patients with clinically localized had completed cancer treatment. Fatigue search, said it’s a helpful addition to prostate cancer treated by a single sur- is extremely common among cancer existing knowledge. The cost of ginseng geon between 2002 and 2009 pelvic patients; most of those in the study suf- will be inexpensive compared to pre- lymph nodes were removed and submit- fered from breast cancer. scription drugs that could be used to ted to the pathologist in separate packets treat fatigue, she said. (external iliac, obturator and hypogas- The patients took capsules of pure tric). We assessed the total number of American ginseng instead of some over- Why might ginseng help fatigue? It’s nodes and the number with metastases the-counter ginseng products that can not clear, said Murphy, who has studied in each packet. include ethanol. Ethanol may be poten- the herb. “Essentially, when healthy tially dangerous to breast cancer pa- people ingest ginseng, there are no nota- Results: Complete pathological infor- tients, study researcher Debra Barton of ble effects,” she said. “However, when mation was available for 427 patients, the Mayo Clinic Cancer Center said in a an ill person takes ginseng, they tend to who had a median of 16 lymph nodes news release from the clinic. feel more normal.” removed. Of the patients 35 (8.2%) had lymph node metastases, including 1.7% “After eight weeks, we saw a 20-point The study, funded by the U.S. National with low, 8.6% with intermediate and improvement in fatigue in cancer pa- Cancer Institute and the Breast Cancer 23.9% with high risk cancer. Of those tients, measured on a 100-point, stand- Research Foundation, was scheduled to with nodal metastases 24 (69%) had ardized fatigue scale,” Barton said. be released June 4 at the annual meeting positive lymph nodes in only 1 of the 3 Those who took the ginseng capsules of the American Society of Clinical On- areas, including the external iliac in 4 didn’t report much improvement at four cology in Chicago. (11%), the obturator in 9 (26%) and the weeks, but at eight weeks they reported The data and conclusions of research hypogastric in 11 (31%). Only 37% of they felt less “worn out,” “fatigued,” presented at medical meetings should be the patients had positive nodes only in “sluggish” or “tired,” compared to those viewed as preliminary until published in the external iliac area above the obtura- who took the placebo, the investigators a peer-reviewed journal. tor nerve while 60% and 49% had at found. HealthDay News, 4 June 2012 least 1 positive node in the obturator and The study authors noted that ginseng the hypogastric area, respectively. Of didn’t seem to have any side effects. the patients 80% had only 1 (49%) or 2 They didn’t specify how much the gin- (31%) positive nodes. Conclusions: In contemporary American US TOO WANTS TO ANSWER patients with clinically localized prostate YOUR QUESTIONS ! cancer, lymph node metastases were Dr. Myers would love to provide direct found more often and frequently exclu- answers to questions posed by Us TOO sively in the obturator and hypogastric members. Instead of printing questions areas than in the external iliac area. Pel- answered in the Prostate Forum , we’d vic lymph node dissection limited to the rather provide readers who subscribe to external iliac area above the obturator both publications with fresh content. nerve would identify and remove lymph Questions about imaging, active surveil- node metastases in only a third of the lance, and biochemical relapse would be patients with positive nodes found at full particularly appreciated right now. pelvic lymph node dissection. If you have questions, please send them to or call the Help- line at 800-808-7866.

PAGE 6 PROSTATE CANCER HELPLINE - CALL 1-800-808-7866 OR WWW.USTOO .ORG

DOC MOYAD ’S WHAT WORKS & WHAT IS WORTHLESS COLUMN , A LSO NAD IA P ROS VUE TEST KNOWN AS “N O BOGUS SCIENCE ” C OLUMN (Continued from page 2) “You want a real cheap ANTI-AGING secret...well I have one for you!” In an interview with Medscape Medical Mark A. Moyad, MD, MPH News, Dr. McDermed said that “by be- Medical Center, Department of Urology ing able to measure more than 10 times Editors’ note : Us TOO has invited certain physicians and others to provide information and below the detection limits of other as- commentary for the HotSheet to enrich its content to empower the reader. This column contains says, if there is a change in the PSA from the opinions and thoughts of its author and is not necessarily those of Us TOO International. month to month, we can measure it and it Bottom Line: One of the cheapest anti- Isn’t it interesting that these benefits were is a real change,” not variability inherent aging secrets is ______(did you really found from very cheap sources of fiber?! in the assay itself. Geoff Metcalf, Vice think I was going to give away the secret I mean we are not talking about fiber pills President of Sales and Business Develop- right at the beginning like I always do?) or powders here, but more “natural” ment at Iris Personalized Medicine, ex- plained that this test is similar in its ap- Some things never change such as toilet sources of fiber. Researchers are also learning that fiber has multiple mecha- proach to a prognostic test for breast paper, coat hangers, elevator call but- nisms of action from changing intestinal cancer. “It gives clinicians an idea about tons, crying babies in the airplane seats contents to help lower cholesterol, reduce how well the patient will do.” in front and in back of you, and the fact markers of inflammation, promotes the that fiber may be the healthiest internal “This is a major advance in the manage- feeling of fullness to reduce weight, al- anti-aging ingredient that you can get ment of prostate cancer,” Metcalf said. lows more healthy bacteria to occupy the your hands on folks. Another large pro- After RP, “most men are placed into risk colon to lower the risk of infections, and spective study on fiber has been pub- categories using nomograms; with that, brings water into the stool so that a lished, this time from 10 European there are still many questions about healthy bowel movement can occur and countries that included 452,717 men and whether a man will develop clinical you are not plugged up more than your recurrence,” he said. “With this test, we women that were followed for an aver- local barber/salon shop drain after a full 1 are able, with 92.7% accuracy, to identi- age of almost 13 years! This is a long day of cutting hair. Some folks want clear fy men who will not clinically recur time to be followed, I mean heck my cut data that fiber reduces the risk of within 8 years of RP,” he said. “This is wife and I have a private investigator prostate cancer or the progression of this not PSA recurrence, but clinical recur- follow my teenage kids when we are out disease, but that research is lacking. rence detected by biopsies or imaging.” of town just for a few days, so 13 years However, what is known is that cheap is a long time. Anyway I digress, but the sources of fiber and getting just 20-30 Independent commentator David I. Lee, researchers found a relationship between grams a day from these sources may help MD, assistant professor of surgery/ increased fiber intake from cereals and you live longer and better because it has urology at the Perelman School of Med- vegetables and a lower risk of dying so many internal anti-aging properties icine, University of Pennsylvania, in from any cause, and the benefits were (even reduces the risk of acid reflux, di- , said he thinks the test is similar for men as well as women. verticulitis and hemorrhoids). Oh, and if “very clinical relevant.” According to you want to spend pennies then just buy Dr. Lee, the gold-standard method of US TOO S EEKS BOARD MEMBER Fiber One (look for the new 80 calorie following men after RP for prostate can- option) cereal, All-Bran Buds cereal, or cer is monitoring PSA, which should be APPLICATIONS even a high fiber oatmeal brand such as undetectable; if it becomes detectable, it Us TOO International, is seeking quali- Quaker Oats. You will not be disappoint- is a sign of cancer recurrence. fied individuals to serve on its Board of ed…in other words…”Gentleman start “The ProsVue test, because of its very Directors. Members have been diag- your engines, and where the heck is that nosed with prostate cancer, are a mem- sensitive profile, may be able to detect Sunday newspaper I need to read from recurrences earlier, enabling men to ber of such a man’s family or significant cover to cover”… decide on other treatment options soon- other, or any person involved in or inter- Reference er,” he stated. “There is no other assay ested in support or treatment of such patients. Other qualifications include 1. Chuang SC, Norat T, Murphy N et al. that is of any use; therefore, the ProsVue familiarity with an Us TOO chapter, Am J Clin Nutr, 2012 30 May [Epub test may become very useful because of ability to think globally, skills or experi- ahead of print] its sensitivity,” he added. According to Dr. Lee, this test might be especially ence deemed beneficial to the work of useful for men with higher-risk patholo- Us TOO and commitment to Us TOO’s purpose and mission. See details at gy, in whom a slow ProsVue result www.ustoo.org/SeekBoardMembers.asp . might lead a man not to undergo adju- Send letters of nomination with a vita or vant radiation. “Likewise, a concerning resume to Thomas Kirk, President and score may lead some men to start radia- tion or hormonal therapy earlier than CEO, Us TOO International, 5003 Fair- view Avenue, Downers Grove, IL otherwise contemplated,” he said. 60515 or e-mail [email protected]. Medscape Medical News, 25 May 2012

US TOO I NTERNATIONAL PROSTATE CANCER EDUCATION & S UPPORT HOT SHEET – JULY 2012 PAGE 7

DOCTOR CHODAK ’S BOTTOM LINE (Ref Key: article #, page #, column #) Author: Winning The Battle Against Prostate Cancer, 2011 Editors’ note : Us TOO has invited certain physicians and others to provide information and commentary for the HotSheet to enrich its content to empower the reader. This column contains the opinions and thoughts of its author and is not necessarily those of Us TOO International. In this month’s HotSheet , there are three gether. Enzalutamide is also being tested THE BOTTOM LINE: More data are very important reports with clinical im- prior to chemotherapy and is highly like- needed to know if using standardized plications for men with advanced pros- ly to show a benefit too. If that occurs, image analysis could substitute for the tate cancer. The first ( a1p1c1 ) involves the same questions will need to be an- interpretation given by pathologists. new information about the effect of inter- swered in men naïve to chemotherapy. a6p3c3 The article by McNeil argues in mittent hormone therapy (IHT) for men THE BOTTOM LINE: Men with ad- support of screening claiming that with- with metastatic prostate cancer. For vanced castration resistant prostate can- out screening many men will not be many years, men have been using IHT cer are likely to have two additional diagnosed until their cancer has spread. rather than continuous HT, believing that options, enzalutamide for those failing Clearly, this is one of the discussion survival is just as good but quality of life chemotherapy and abiraterone for those points that men should hear when pre- is improved during the drug holidays. who have not yet been treated with it. sented the pros and cons of screening. Recently, a randomized study from Eu- However, much more discussion is rope showed that the overall survival was a4p2c2 Some men who have undergone needed for men to make an informed not different, but men on IHT had a high- a radical prostatectomy (RP) are still decision than just telling them about the er death rate from prostate cancer and a destined to develop a recurrence. The risk of developing metastatic disease. lower death rate from other causes. Now most useful predictors are the pathology a larger, and longer randomized study report and the Gleason score. Now a new THE BOTTOM LINE: Telling men has shown that IHT in men with meta- test is being used to help identify men about the potential to develop metastatic static disease actually has a lower surviv- who are unlikely to recur. The ProsVue disease if they don’t get screened is an al rate compared continuous HT by about slope separates men into a low chance important but very incomplete part of eight months. Going forward this means and high chance for recurrence with the what men need to know about screening. men will have to decide if a better quality idea that it may help some men avoid a7p5c3 Another continuing controversy of life is worth a reduced survival rate. unnecessary treatment. This test could involves what to do about the pelvic Whether this is also true for non- benefit many men except for one major lymph nodes at the time of RP. Should metastatic disease requires another study. problem. At this time there is little evi- they be removed, should the surgeon THE BOTTOM LINE: IHT is inferior dence that men benefit from getting de- wait for the frozen section results before to continuous therapy in men with meta- layed radiation so even if they are in the removing the prostate, and which lymph static prostate cancer. high risk group, it is unclear what to do nodes should be obtained? So far, no The other two important articles contain about it. One could easily make a case randomized study has shown a therapeu- information from the 2012 ASCO meet- that both risk groups should not receive tic benefit from removing the lymph ing. One study ( a2p1c2 ) tested enzalu- additional local therapy, and at this time nodes regardless of whether they do or tamide (MDV3100), a new antiandrogen there is no proof that hormone or chemo- do not contain cancer. Often, doctors in men with metastatic prostate cancer therapy will improve survival in either remove some lymph nodes but do not who progressed after receiving docet- group. So for now, the test may not be so wait for results. This is good for the axel. The other study ( a3p1c3 ) tested useful until we have proof that treating doctor but clearly not good for the pa- abiraterone in men with progressive met- men based on the ProsVue test will im- tient. When a more extensive dissection astatic disease who were naïve to chem- prove survival. is done, more abnormal lymph nodes are detected, but complications can occur otherapy. In both drug studies, the safety THE BOTTOM LINE: The ProsVue and surgery is longer. This report pro- committees recommended stopping the test may one day be useful for all high- vides additional evidence that removing studies early because the drugs showed risk men but at this time, it is unlikely to the external lymph nodes alone will significant benefit. For the enzalutamide, be very useful for selecting treatment. it improved survival while the abi- often miss cancer and so this article sup- raterone delayed the time to radiographic a5p2c3 Almost everyone is aware that ports doing a more extensive dissection. Gleason score interpretation is highly progression but had not yet reached a THE BOTTOM LINE: If performed, a subjective. Methods that could lower the survival benefit. There were no major limited lymph node dissection is not variability would be very advantageous safety issues with abiraterone but en- going to be adequate. zalutamide caused seizures in 6 out of and could reduce the number of second 1,000 men. FDA will review these re- opinions obtained. The idea of using im- Join us! age analysis is not new. This preliminary sults and then decide whether they Sunday, study is encouraging but at this time more should be approved. If they do, new Sept 16, 2012 questions will emerge. For men who data are needed to know its overall accu- Lincoln Park, have progressed on chemotherapy, the racy. It will be interesting to see how the Chicago, IL question becomes which drug should be method compares with pathologists with a given first or should both be given to- expertise in interpreting prostate biopsies. www.SEABlueProstateWalk.org

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SCREENING CAN BE DIFFERENCE OGX-427 I MPROVES PROGRESSION -FREE SURVIVAL IN PROSTATE CANCER BETWEEN LIFE AND DEATH OncoGenex Pharmaceuticals Inc. an- -427 plus prednisone experienced a (Continued from page 3) nounced data from a Phase 2 study of its >50% decline in PSA, versus 20% of Of the men who underwent radiographic investigational compound OGX-427 in men who received prednisone alone. imaging, 50 (45%) had lymphadenopa- chemotherapy-naive metastatic castra- Among the 21 patients with baseline thy suspicious for metastasis, 14 (19%) tion resistant prostate cancer (mCRPC). measurable disease, 4/9 (44% ) vs. 0/12 had masses suspicious for visceral me- Preliminary results show a higher pro- (0%) responded in the OGX-427 plus tastases and three (4%) had evidence of gression-free survival (PFS) in patients prednisone arm and prednisone alone local progression. All patients had bone taking OGX-427 plus prednisone at 12 arms. There was 1 complete response in scans. Virtually all (97%) had positive weeks and with PSA declines, compared the OGX-427 plus prednisone arm. findings, with 11 (7%) showing signs of with those taking prednisone alone. The authors concluded that OGX-427 cord compression. Sixty-four of 72 planned subjects have appears well-tolerated. Adverse events The median time for rise of PSA levels been randomized to the study and data (AEs) have been predominately grade 1- on 42 men [22 who received OGX-427 2 and related to infusion reactions. after they reached a nadir was 228.5 plus prednisone and 20 who received Three grade 4 AEs have been reported days. The median survival duration was prednisone alone] are now available at and include dizziness, pulmonary embo- slightly more than four years. Two- and or beyond the 12 week assessment time lus and hemolytic uremic syndrome. five-year cancer specific survival rates point. Highlights are as follows: were 68% and 39%, respectively. OGX-427 is believed to work by inhibit- In the OGX-427 plus prednisone arm, ing the production of Hsp27, a cell- “The scary thing for me is that the US 71% of patients were progression-free at survival protein expressed in many Preventive Services Task Force recom- 12 weeks, vs. to 40% in the prednisone types of cancers including prostate, mendations could discourage some men arm. The primary efficacy endpoint of bladder, pancreas, breast and non-small from getting screened who would bene- this study is defined as PFS at 12 weeks cell lung cancer. Overexpression of fit from screening. With the patients in where disease progression is based on Hsp27 is thought to be an important our study, who knows what would have any of the following parameters: rising factor leading to the development of happened if they were screened and the PSA levels, measurable disease, bone treatment resistance and is associated cancer was detected much earlier,” Dr. lesions, global deterioration or require- with negative clinical outcomes in pa- McNeil said. ment of palliative radiation therapy. tients with various tumor types. Reuters Health, 29 May 2012 Fifty percent of men who received OGX www.dddmag.com ,7 June 2012

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