Toremifene for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia: Results of a Double-Blind, Placebo Controlled, Phase IIB Clinical Trial

Journal of Urology

Volumn 176, Issue 3, 2006, Pages 965-971

  Price, David ^a   Stein, Barry ^b   Sieber, Paul ^c   Tutrone, Ronald ^d   Bailen, James ^e   Goluboff, Erik ^f   Burzon, Daniel ^g   Bostwick, David ^h   Steiner, Mitchell ⁱ  

^a Regional Urology L L C   (United States)

^b University Urological Associates Inc   (United States)

^c Urological Associates of Lancaster   (United States)

^d Chesapeake Urology Associates   (United States)

^e Metropolitan Urology   (United States)

^f Och Spine at New York Presbyterian Hospitals   (United States)

^g Coastal Urology Associates ^*  (United States)

^h BOSTWICK LABORATORIES   (United States)

ⁱ GTx Inc   (United States)

Author keywords

estrogens; prostatic intraepithelial neoplasia; prostatic neoplasms; selective estrogen receptor modulators; toremifene

Indexed keywords

ESTRADIOL; FOLLITROPIN; LUTEINIZING HORMONE; TESTOSTERONE; TOREMIFENE;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ARTICLE; CANCER INCIDENCE; CANCER PREVENTION; CANCER RISK; CANCER SCREENING; CATARACT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRY EYE; ERECTILE DYSFUNCTION; ESTRADIOL BLOOD LEVEL; FATIGUE; FOLLITROPIN BLOOD LEVEL; GLEASON SCORE; HEART ARRHYTHMIA; HOT FLUSH; HUMAN; LIBIDO DISORDER; LUTEINIZING HORMONE BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; NAUSEA; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE CANCER; PROSTATIC INTRAEPITHELIAL NEOPLASIA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TESTOSTERONE BLOOD LEVEL; THROMBOEMBOLISM; TUMOR BIOPSY; URINARY FREQUENCY; VISUAL ACUITY; VISUAL DISORDER;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, HORMONAL; DOUBLE-BLIND METHOD; HUMANS; MALE; MIDDLE AGED; PROSTATIC INTRAEPITHELIAL NEOPLASIA; PROSTATIC NEOPLASMS; TOREMIFENE;

EID: 33746524463     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.juro.2006.04.011     Document Type: Article

References (23)

1. Algaba F. Evolution of isolated high-grade prostate intraepithelial neoplasia in a Mediterranean patient population. Eur Urol 35 (1999) 496
2. Balaji K.C., Rabbani F., Tsai H., Bastar A., and Fair W.R. Effect of neoadjuvant hormonal therapy on prostatic intraepithelial neoplasia and its prognostic significance. J Urol 162 (1999) 753
3. Bostwick D.G. High-grade prostatic intraepithelial neoplasia. the most likely precursor of prostate cancer. Cancer 75 (1995) 1823
4. Bostwick D.G., Pacelli A., and Lopez-Beltran A. Molecular biology of prostatic intraepithelial neoplasia. Prostate 29 (1996) 117
5. Bostwick D.G. Prospective origins of prostate carcinoma. Prostatic intraepithelial neoplasia and atypical adenomatous hyperplasia. Cancer 78 (1996) 330
6. Bostwick D.G. Prostatic intraepithelial neoplasia. Curr Urol Rep 1 (2000) 65
7. Bostwick D.G. Prostatic intraepithelial neoplasia is a risk factor for cancer. Semin Urol Oncol 17 (1999) 187
8. Bostwick D.G. Prostatic intraepithelial neoplasia (PIN). Urology 34 (1989) 16
9. Brawer M.K. Prostatic intraepithelial neoplasia. a premalignant lesion. Hum Pathol 23 (1992) 242
10. Carroll P.R., Lee K.L., Fuks Z., and Kantoff P.W. Cancers of the genitourinary system. In: DeVita Jr. V.T., Hellman S., and Rosenberg S.A. (Eds). Principles and Practice of Oncology. 6th ed. (2001), Lippincott Williams & Wilkins, Philadelphia 1418-1479
11. O'Shaughnessy J.A., Kelloff G.J., Gordon G.B., Dannenberg A.J., Hong W.K., Fabian C.J., et al. Treatment and prevention of intraepithelial neoplasia. an important target for accelerated new agent development. Clin Cancer Res 8 (2002) 314
12. Steiner M.S. High-grade prostatic intraepithelial neoplasia and prostate cancer risk reduction. World J Urol 21 (2003) 15
13. Ehara H., Koji T., Deguchi T., Yoshii A., Nakano M., Nakane P.K., et al. Expression of estrogen receptor in diseased human prostate assessed by non-radioactive in situ hybridization and immunohistochemistry. Prostate 27 (1995) 304
14. Leav I., Ho S.M., Ofner P., Merk F.B., Kwan P.W., and Damassa D. Biochemical alterations in sex hormone-induced hyperplasia and dysplasia of the dorsolateral prostates of Noble rats. J Natl Cancer Inst 80 (1988) 1045
15. Leav I., Merk F.B., Kwan P.W., and Ho S.M. Androgen-supported estrogen-enhanced epithelial proliferation in the prostates of intact Noble rats. Prostate 15 (1989) 23
16. Ofner P., Bosland M.C., and Vena R.L. Differential effects of diethylstilbestrol and estradiol-17 beta in combination with testosterone on rat prostate lobes. Toxicol Appl Pharmacol 112 (1992) 300
17. Wang Y.Z., Hayward S.W., Cao M., Young P., Cunha G.R., and Cardiff R.D. Role of estrogen signaling in prostatic hormonal carcinogenesis. J Urol 165 suppl. (2001) 132 abstract 543
18. Raghow S., Hooshdaran M.Z., Katiyar S., and Steiner M.S. Toremifene prevents prostate cancer in the transgenic adenocarcinoma of mouse prostate model. Cancer Res 62 (2002) 1370
19. Steiner M.S., and Pound C.R. Phase IIA clinical trial to test the efficacy and safety of toremifene in men with high-grade prostatic intraepithelial neoplasia. Clin Prostate Cancer 2 (2003) 24
20. Paganini-Hill A., and Clark L.J. Eye problems in breast cancer patients treated with tamoxifen. Breast Cancer Res Treat 60 (2000) 167
21. Fisher B., Constantino J.P., Wickerham D.L., Redmond C.K., Kavanah M., Cronin W.M., et al. Tamoxifen for prevention of breast cancer. report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 90 (1998) 1371
22. Uzzo R.G., Wei J.T., Waldbaum R.S., Perlmutter A.P., Byrne J.C., and Vaughan Jr. E.D. The influence of prostatic size on cancer detection. Urology 46 (1995) 831
23. Price D., Israeli R.S., Boger R., Steiner M.S., and GTx-006-211 Study Group. Concentration-dependent estrogen receptor binding profile of toremifene may account for its clinical dose-response profile. J Urol 173 suppl. (2005) 274 abstract 1012