Clinical trials in relapsed prostate cancer: Defining the target

Journal of the National Cancer Institute

Volumn 88, Issue 22, 1996, Pages 1623-1634

  Scher, Howard I ^a,b   Mazumdar, Madhu ^a   Kelly, William Kevin ^a,b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; ESTRAMUSTINE; ETOPOSIDE; PACLITAXEL; PROSTATE SPECIFIC ANTIGEN; VINBLASTINE;

CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; DISEASE COURSE; DRUG RESEARCH; DRUG SCREENING; HUMAN; PROSTATE CANCER; REVIEW; TREATMENT OUTCOME;

CLINICAL TRIALS; HUMANS; MALE; NEOPLASM RECURRENCE, LOCAL; NEOPLASMS, HORMONE-DEPENDENT; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; QUALITY OF LIFE; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 0029808474     PISSN: 00278874     EISSN: None     Source Type: Journal    
DOI: 10.1093/jnci/88.22.1623     Document Type: Review

References (90)

1. Norton L, Simon R. Tumor size, sensitivity to therapy, and the design of treatment schedules. Cancer Treat Rep 1977;61:1307-17.
2. Norton L, Simon R. The Norton-Simon hypothesis revisited. Cancer Treat Rep 1986;70:163-9.
3. Isaacs WB, Bova GS, Morton RA, Bussemakers MJ, Brooks JD, Ewing CM. Molecular biology of prostate cancer. Semin Oncol 1994;21:514-21.
4. Effert PJ, Neubauer A, Walther PJ, Liu ET. Alterations of the P53 gene are associated with the progression of a human prostate carcinoma. J Urol 1992;147(3 Pt 2):789-93.
5. Van Veldhuizen PJ, Sadasivan R, Garcia F, Austenfeld MS, Stephens RL. Mutant p53 expression in prostate carcinoma. Prostate 1993;22:23-30.
6. Bookstein R, MacGrogan D, Hilsenbeck SG, Sharkey F, Allred DC. p53 is mutated in a subset of advanced-stage prostate cancers. Cancer Res 1993;53:3369-73.
7. Sella A, Kilbourn R, Amato R, Bui C, Zukiwski A, Ellerhorst J, et al. Phase II study of ketoconazole combined with weekly doxorubicin in patients with androgen-independent prostate cancer. J Clin Oncol 1994; 12:683-8.
8. Seidman AD, Scher HI, Petrylak D, Dershaw DD, Curley T. Estramustine and vinblastine: use of prostate specific antigen as a clinical trial end point in hormone refractory prostatic cancer. J Urol 1992;147:931-4.
9. Hudes GR, Greenberg R, Krigel RL, Fox S, Scher R, Litwin S, et al. Phase II study of estramustine and vinblastine, two microtubule inhibitors, in hormone-refractory prostate cancer. J Clin Oncol 1992;10:1754-61.
10. Amato RJ, Ellerhorst J, Bui C, Logothetis CJ. Estramustine and vinblastine for patients with androgen-independent adenocarcinoma of the prostate. Urol Oncol 1995;1:168-72.
11. Pienta KJ, Redman B, Hussain M, Cummings G, Esper PS, Appel C, et al. Phase II evaluation of oral estramustine and oral etoposide in hormone-refractory adenocarcinoma of the prostate [see comment citation in Medline]. J Clin Oncol 1994;12:2005-12.
12. Hudes GR, Nathan FE, Khater C, Greenberg R, Gomella L, Stein C, et al. Paclitaxel plus estramustine in metastatic hormone-refractory prostate cancer. Semin Oncol 1995;22(5 Suppl 12):41-5.
13. Porter AT, McEwan AJ, Powe JE, Reid R, McGowan DG, Lukka H, et al. Results of a randomized phase-III trial to evaluate the efficacy of strontium-89 adjuvant to local field external beam irradiation in the management of endocrine resistant prostate cancer. Int J Radiat Oncol Biol Phys 1993;25:805-13.
14. Ekman P, Brolin J. Steroid receptor profile in human prostate cancer metastases as compared with primary prostatic carcinoma. Prostate 1991; 18:147-53.
15. Clarke NW, Holbrook IB, McClure J, George NJ. Osteoclast inhibition by pamidronate in metastatic prostate cancer: a preliminary study. Br J Cancer 1991;63:420-3.
16. Sun YC, Geldof AA, Newling DW, Roa BR. Progression delay of prostate tumor skeletal metastasis effects by bisphosphonates. J Urol 1992;148: 1270-3.
17. Moore MJ, Osoba D, Murphy K, Tannock IF, Armitage A, Findlay B, et al. Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer. J Clin Oncol 1994;12:689-94.
18. Chodak GW, Vogelzang NJ, Caplan RJ, Soloway M, Smith JA. Independent prognostic factors in patients with metastatic (stage D2) prostate cancer. The Zoladex Study Group [see comment citation in Medline]. JAMA 1991;265:618-21.
19. de Voogt HJ, Suciu S, Sylvester R, Pavone-Macaluso M, Smith PH, de Pauw M. Multivariate analysis of prognostic factors in patients with advanced prostatic cancer: results from 2 European Organization for Research on Treatment of Cancer Trials. J Urol 1989;141:883-8.
20. Soloway MS, Ishikawa S, van der Zwaag R, Todd B. Prognostic factors in patients with advanced prostate cancer. Urology 1989;33(5 Suppl):53-60.
21. Berry WR, Laszlo J, Cox E, Walker A, Paulson D. Prognostic factors in metastatic and hormonally unresponsive carcinoma of the prostate. Cancer 1979;44:763-75.
22. Fossa SD, Dearnaley DP, Law M, Gad I, Newling DW, Tveter K. Prognostic factors in hormone-resistant progressing cancer of the prostate [see comment citation in Medline]. Ann Oncol 1992;3:361-6.
23. Kelly WK, Scher HI, Mazumdar M, Vlamis V, Schwartz M, Fossa SD. Prostate-specific antigen as a measure of disease outcome in metastatic hormone-refractory prostatic cancer [see comment citation in Medline]. J Clin Oncol 1993;11:607-15.
24. Fossa SD, Paus E, Lindegaard M, Newling DW. Prostate-specific antigen and other prognostic factors in patients with hormone-resistant prostatic cancer undergoing experimental treatment. Br J Urol 1992;69:175-9.
25. Eisenberger MA, Crawford ED, Wolf M, Blumenstein B, McLeod DG, Benson R, et al. Prognostic factors in stage D2 prostate cancer; important implications for future trials: results of a cooperative intergroup study (INT. 0036). The National Cancer Institute Intergroup Study #0036. Semin Oncol 1994;21:613-9.
26. Sridhara R, Eisenberger MA, Sinibaldi VJ, Reyno LM, Egorin MJ. Evaluation of prostate-specific antigen as a surrogate marker for response of hormone-refractory prostate cancer to suramin therapy. J Clin Oncol 1995;13:2944-53.
27. Scher HI, Yagoda A. Clinical trials in prostatic cancer: methodology and controversies. In: Bruce AW, Trachtenberg J, editors. Adenocarcinoma of the prostate. New York: Springer-Verlag, 1987:197-220.
28. Fair WR, Aprikian A, Sogani P, Reuter V, Whitmore WF Jr. The role of neoadjuvant hormonal manipulation in localized prostatic cancer. Cancer 1993;71(3 Suppl):1031-8.
29. Moul JW. Neoadjuvant hormonal therapy for clinically localized prostate cancer. Urol Ann 1996;1046:47-56.
30. Akakura K, Bruchovsky N, Goldenberg SL, Rennie PS, Buckley AR, Sullivan LD. Effects of intermittent androgen suppression on androgen-dependent tumors. Apoptosis and serum prostate-specific antigen. Cancer 1993;71:2782-90.
31. Taylor CD, Elson P, Trump DL. Importance of continued testicular suppression in hormone-refractory prostate cancer. J Clin Oncol 1993;11: 2167-72.
32. Manni A, Santen RJ, Boucher A, Lipton A, Harvey H, Simmonds M, et al. Hormone stimulation and chemotherapy in advanced prostate cancer: preliminary results of a prospective controlled clinical trial. Anticancer Res 1985;5:161-5.
33. Stein CA, Saville W, Yarchoan R, Broder S, Gelmann EP. Suramin and function of the adrenal cortex [letter]. Ann Intern Med 1986;104:286-7.
34. Kelly WK, Curley T, Liebertz C, Dnistrian A, Schwartz M, Scher HI. Prospective evaluation of hydrocortisone and suramin in patients with androgen-independent prostate cancer. J Clin Oncol 1995;13:2208-13.
35. Yagoda A, Smith JA, Soloway MS, Tomera K, Seidmon EJ, Olsson C, et al. Phase II study of estramustine phosphate in advanced hormone refractory prostatic cancer with increasing prostate specific antigen levels [abstract]. J Urol 1991;145:384A.
36. Scher HI, Kelly WK. Flutamide withdrawal syndrome: its impact on clinical trials in hormone-refractory prostate cancer. J Clin Oncol 1993;11: 1566-72.
37. Dupont A, Gomez JL, Cusan L, Koutsilieris M, Labrie F. Response to flutamide withdrawal in advanced prostate cancer in progression under combination therapy. J Urol 1993;150:908-13.
38. Sartor O, Cooper M, Weinberger M, Headlee D, Thibault A, Tompkins A, et al. Surprising activity of flutamide withdrawal, when combined with aminoglutethimide, in treatment of hormone-refractory prostate cancer [published erratum appears in J Natl Cancer Inst 1994;86:436]. J Natl Cancer Inst 1994;86:222-7.
39. Scher HI, Zhang ZF, Nanus D, Kelly WK. Hormone and antihormone withdrawal: implications for the management of androgen-independent prostate cancer. Urology 1996;47:61-9.
40. Small EJ, Carroll PR. Prostate-specific antigen decline after casodex withdrawal: evidence for an antiandrogen withdrawal syndrome [see comment citation in Medline]. Urology 1994;43:408-10.
41. Nieh PT. Withdrawal phenomenon with the antiandrogen casodex. J Urol 1995;153(3 Pt 2):1070-2; discussion 1072-3.
42. Dawson NA, McLeod DG. Dramatic prostate specific antigen decrease in response to discontinuation of megestrol acetate in advanced prostate cancer: expansion of the antiandrogen withdrawal syndrome. J Urol 1995; 153:1946-7.
43. Bissada NK, Kaczmarek AT, Complete remission of hormone refractory adenocarcinoma of the prostate in response to withdrawal of diethylstilbestrol. J Urol 1995;153:1944-5.
44. Kelly WK, Curley T, Liebertz C, Kim B, Scher H. Phase II trial of 13-cis retinoic acid and interferon-alpha 2a in patients with adenocarcinoma of the prostate [abstract]. Proc ASCO 1996;15:254.
45. Kennealey GT, Furr BJ. Use of the nonsteroidal anti-androgen Casodex in advanced prostatic carcinoma. Urol Clin North Am 1991;18:99-110.
46. Ferlazzo G, Magno C, Lupo G, Rizzo M, Iemmo R, Semino C, et al. A phase I study of intravesical continuous perfusion of recombinant interleukin-2 in patients with superficial bladder cancer. Am J Clin Oncol 1995;18:100-4.
47. Scher HI, Steineck G, Kelly WK. Hormone-refractory (D3) prostate cancer: refining the concept. Urology 1995;46:142-8.
48. Eisenberger MA, Simon R, O'Dwyer PJ, Wittes RE, Friedman MA. A reevaluation of nonhormonal cytotoxic chemotherapy in the treatment of prostatic carcinoma. J Clin Oncol 1985;3:827-41.
49. Tannock IF. Is there evidence that chemotherapy is of benefit to patients with carcinoma of the prostate? J Clin Oncol 1985;3:1013-21.
50. Kreis W. Current chemotherapy and future directions in research for the treatment of advanced hormone-refractory prostate cancer. Cancer Invest 1995;13:296-312.
51. Scher H, Yagoda A, Watson RC, Serber M, Whitmore W. Phase II trial of doxorubicin in bidimensionally measurable prostatic adenocarcinoma. J Urol 1984;131:1099-102.
52. Torti FM, Aston D, Lum BL, Kohler M, Williams R, Spaulding JT, et al. Weekly doxorubicin in endocrine-refractory carcinoma of the prostate. J Clin Oncol 1983;1:477-82.
53. O'Bryan RM, Baker LH, Gottleib JE, Rivkin SE, Balcerzak SP, Grumet GN, et al. Dose response evaluation of adriamycin in human neoplasia. Cancer 1977;39:1940-8.
54. Slack NH, Mittelman A, Brady MF, Murphy GP. The importance of the stable category for chemotherapy treated patients with advanced and relapsing prostate cancer. Cancer 1980;46:2393-402.
55. Raghavan D, Pearson BS, Coorey GJ, Rosen IM, Farebrother TD, Bilenkij P, et al. Management of hormone-resistant prostate cancer: experience at Royal Prince Alfred Hospital. In: Johnson DE, Logothetis CJ, von Eschenbach AC, editors. Systemic therapy for genitourinary cancers. Chicago: Year Book Medical Publishers, 1989:245-50.
56. Kantoff PW, Bryant P, Block C, Rieker P, George MJ. Fourteen day constant infusion of mitoxantrone HCL for hormone refractory carcinoma of the prostate (HRCaP): a pilot dose finding study [abstract]. Proc ASCO 1991;10:175.
57. di Sant'Agnese PA, de Mesy Jensen KL. Neuroendocrine differentiation in prostatic carcinoma. Hum Pathol 1987;18:849-56.
58. Ro JY, Tetu B, Ayala AG, Ordonez NG. Small cell carcinoma of the prostate. II. Immunohistochemical and electron microscopic studies of 18 cases. Cancer 1987;59:977-82.
59. Scher HI, Yagoda A, Ahmed T, Watson RC. Methylglyoxal-bis(guanyl-hydrazone) in hormone-resistant adenocarcinoma of the prostate. J Clin Oncol 1985;3:224-8.
60. Goldenberg SL, Bruchovsky N, Rennie PS, Coppin CM. The combination of cyproterone acetate and low dose diethylstilbestrol in the treatment of advanced prostatic carcinoma. J Urol 1988;138:1460-5.
61. Scher HI, Chung LW. Bone metastases: improving the therapeutic index. Semin Oncol 1994;21:630-56.
62. Logothetis CJ, Samuels ML, von Eschenbach AC, Trindade A, Ogden S, Grant C, et al. Doxorubicin, mitomycin-C, and 5-fluorouracil (DMF) in the treatment of metastatic hormonal refractory adenocarcinoma of the prostate, with a note on the staging of metastatic prostate cancer. J Clin Oncol 1983;6:368-79.
63. Soloway MS, Hardeman SW, Hickey D, Raymond J, Todd B, Soloway S, et al. Stratification of patients with metastatic prostate cancer based on extent of disease on initial bone scan. Cancer 1988;61:195-202.
64. Kelly WK, Scher HI, Mazumdar M, Pfister D, Curley T, Liebertz C, et al. Suramin and hydrocortisone: determining drug efficacy in androgen-independent prostate cancer. J Clin Oncol 1995;13:2214-22.
65. Sabbatini P, Yeung H, Imbriaco M, Mazundar M, Kelly WK, Larson S, et al. The utility of serial bone scintigraphy and PSA determinations in the management of patients (Pts) with androgen independent (AI) prostate cancer (PC) [abstract]. Proc ASCO 1996;15:254.
66. McCormack RT, Rittenhouse HG, Finlay JA, Sokoloff RL, Wang TJ, Wolfert RL, et al. Molecular forms of prostate-specific antigen and the human kallikrein gene family: a new era. Urology 1995;45:729-44.
67. Brawer MK, Daum P, Petteway JC, Wener MH. Assay variability in serum prostate-specific antigen determination. Prostate 1995;27:1-6.
68. Stamey TA, Prestigiacomo AF, Chen Z. Standardization of immunoassays for prostate specific antigen. A different view based on experimental observations [see comment citation in Medline]. Cancer 1994;74:1662-73.
69. Scher HI. Prostate cancer: are we closer to rational treatment selection? Curr Opin Oncol 1992;4:442-54.
70. Chackal-Roy M, Niemeyer C, Moore M, Zetter BR. Stimulation of human prostalic carcinoma cell growth by factors present in human bone marrow. J Clin Invest 1989;84:43-50.
71. Montgomery BT, Young CY, Bilhartz DL, Andrews PE, Prescott JL, Thompson NF, et al. Hormonal regulation of prostate-specific antigen (PSA) glycoprotein in the human prostatic adenocarcinoma cell line, LNCaP. Prostate 1992;21:63-73.
72. Scher HI, Curley T, Geller N, Engstrom C, Dershaw DD, Lin SY, et al. Trimetrexate in prostatic cancer: preliminary observations on the use of prostate-specific antigen and acid phosphatase as a marker in measurable hormone-refractory disease. J Clin Oncol 1990;8:1830-8.
73. Fennelly D, Scher HI. Clinical use of suramin. Contemp Oncol 1992;2:38-43.
74. La Rocca RV, Danesi R, Cooper MR, Jamis-Dow CA, Ewing MW, Linehan WM, et al. Effect of suramin on human prostate cancer cells in vitro. J Urol 1991;145:393-8.
75. Stein BS, Vangore S, Petersen RO. Immunoperoxidase localization of prostatic antigens. Comparison of primary and metastatic sites. Urology 1984;24:146-52.
76. Mannini D, Maver P, Aiello E, Corrado G, Vecchi F, Bellanova B, et al. Spontaneous circadian fluctuations of prostate specific antigen and prostatic acid phosphatase serum activities in patients with prostatic cancer. Urol Res 1988;16:9-12.
77. Huggins C, Hodges CV. Studies on prostatic cancer, effect of castration, of estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res 1941;1:293-7.
78. Steineck G, Kelly WK, Mazumdar M, Vlamis V, Schwartz M, Scher HI. Acid phosphatase: defining a role in androgen-independent prostate cancer. Urology 1996;47:719-26.
79. Fossa SD, Aaronson NK, Newling D, van Cangh PJ, Denis L, Kurth KH, et al. Quality of life and treatment of hormone resistant metastatic prostatic cancer. The EORTC Genito-Urinary Group. Eur J Cancer 1990;26:1133-6.
80. Rothenberg ML, Moore MJ, Cripps MC, Andersen JS, Portenoy RK, Burris HA III, et al. A rapid phase II trial of gemcitabine in patients with 5-FU refractory pancreas cancer. Ann Oncol 1996;7:347-53.
81. Fields S, Burris H, Wilding G, Eckardt J, O'Rourke T, Rinaldi D, et al. Evaluating the role of navelbine in hormone refractory prostate cancer: a clinical benefit model [abstract]. Proc ASCO 1994;13:727.
82. Scher HI. Prostate cancer. Are we closer to rational treatment selection? Curr Opin Oncol 1992;4:442-54.
83. Newling DW, Fossa S, Tunn U, Kurth KH, De Pauw M, Sylvester R. Comparison of the effects of high dose estramustine phosphate and mitomycin C on the time to progression and length of survival of patients with progressive, advanced endocrine-independent prostatic cancer: an interim analysis of EORTC-GU Group study no. 30865. J Steroid Biochem Mol Biol 1990;37:971-5.
84. Nordgren H, Nilsson S, Eklov S, Stattin P, Naining W, Heiden T, et al. Modal DNA values and estramustine-binding protein (EMBP) as prognostic markers in prostatic cancer. Acta Oncol 1991;30:211-4.
85. Tannock I, Gospodarowicz M, Meakin W, Panzarella T, Stewart L, Rider W. Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response. J Clin Oncol 1989;7:590-7.
86. Murphy GP, Gibbons RP, Johnson DE, Loehing SA, Prout GR, Schmidt JD, et al. A comparison of estramustine phosphate and streptozotocin in patients with prostatic carcinoma who had extensive irradiation. J Urol 1977;118:288-91.
87. Moore M, O'Sullivan B, Tannock I. How expert physicians would wish to be treated if they developed genitourinary malignancies. J Clin Oncol 1991;6:1736-45.
88. Myers CE, La Rocca R, Stein C, Cooper M, Dawson N, Choyke P, et al. Treatment of hormonally refractory prostate cancer with suramin [abstract]. Proc ASCO 1990;9:133.
89. Soloway MS, Beckley S, Brady MF, Dhabuwala C, Gaeta JF, Gibbons RP, et al. A comparison of estramustine phosphate versus cis-platinum alone versus estramustine phosphate plus cis-platinum in patients with advanced hormone refractory prostate cancer who had had extensive irradiation to the pelvis or lumbosacral area. J Urol 1983;129:56-61.
90. Loening SA, Beckley S, Brady MF, Dhabuwala C, Gaeta JF, Gibbons RP, et al. Comparison of estramustine phosphate, methotrexate and cisplatinum in patients with advanced, hormone refractory prostate cancer. J Urol 1983;129:1001-6.