Clinical Trials in Prostatic Cancer: Methodology and Controversies

  • H. I. Scher
  • A. Yagoda
Part of the Clinical Practice in Urology book series (PRACTICE UROLOG)


Prostatic cancer is a heterogeneous disorder with varying biologic potential. The prevalence of asymptomatic disease in up to 28% of autopsy series has led some to consider this an innocuous disease of the elderly (Breslow et al. 1977; Mettlin 1983). However, despite new biologic markers (Guinan 1981; Pontes 1983; Zweig and Ihde 1985), the proportion of patients with stages C and D at diagnosis has not changed (Slack et al. 1986) and the annual death rate has remained constant (Silverberg 1985). Although new hormonal therapies have recently been introduced (Trachtenberg 1984; Drago et al. 1985; Labrie et al. 1985; Eisenberg et al. 1986), no consistent improvement in response rate, response duration, or survival has been observed. More disturbing is a recent analysis showing an increase in the proportion of deaths attributable to prostatic cancer for patients diagnosed from 1980 to 1983 (Slack et al. 1986). Clearly, new therapeutic modalities are needed.


Prostatic Cancer Clin Oncol Metastatic Prostatic Cancer Prostatic Acid Phosphatase Estramustine Phosphate 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Anderson JR, Cain KC, Gelber RD (1983) Analysis of survival by tumor response. J Clin Oncol 1: 710–719PubMedGoogle Scholar
  2. Bayard S, Greenberg R, Showmutter D et al. (1974) Comparison of treatments for prostatic cancer using an exponential life table model relating survival to concomitant information. Cancer Chemother Rep 58: 845–859PubMedGoogle Scholar
  3. Benson M, McDougal D, Coffey DS (1984) The use of multiparametric flow cytometry to assess tumor cell heterogeneity and grade metastatic prostate cancer. Prostate 5: 27–45PubMedGoogle Scholar
  4. Birch A, Irwin L, Troner M et al. (1985) Diethylstilbesterol (DES) vs. cyclophosphamide (C) + DES as initial therapy for metastatic prostatic carcinoma. A Southeastern Cancer Study Group Trial. Proc Am Soc Clin Oncol 4: 98Google Scholar
  5. Bishop M, Fellows G (1977) Urinary hydroxyproline excretion—a marker of bone metastases in prostate carcinoma. Br J Urol 49: 711–718PubMedGoogle Scholar
  6. Bragg D (1984) Advances in tumor imaging. Hosp Pract 19: 83Google Scholar
  7. Brenckman W, Lastinger L, Sedor F (1981) Unpredictable fluctuations in serum acid phosphatase activity in prostatic cancer. JAMA 245: 2501–2504PubMedGoogle Scholar
  8. Breslow N, Chan CW, Thorm G et al. (1977) Latent carcinoma of the prostate at autopsy in seven areas. Int J Cancer 20: 680–688PubMedGoogle Scholar
  9. Bruce AW, Mahan DE (1982) The role of prostatic acid phosphatase in the investigation and treatment of adenocarcinoma of the prostate. Ann NY Acad Sci 390: 110–113PubMedGoogle Scholar
  10. Bulbul M, Heston WDW, Mirenda C, Fair W (1986) A prostate-derived growth factor partially purified by heparin affinity and anion exchange chromatography (abstr). Proc Am Assoc Cancer Res 27: 852Google Scholar
  11. Buonocore E, Hasemann C, Pavlicek W, Montie J (1984) Clinical and in vitro magnetic resonance imaging of prostatic carcinoma. AJR 143: 1267–1272PubMedGoogle Scholar
  12. Capizzi R, Keiser W, Sartorelli A (1977) Combination chemotherapy—theory and practice. Semin Oncol 4: 227–253PubMedGoogle Scholar
  13. Chisholm GD, O’Donoghue EPN, Kennedy CL (1977) The treatment of estrogen-resistant stage D carcinoma of the prostate with estramustine phosphate. Br J Urol 49: 717–720PubMedGoogle Scholar
  14. Citrin D, Cohen A, Harberg J et al. (1981) Systemic treatment of advanced prostatic cancer: development of a new system for defining response. J Urol 125: 224–228PubMedGoogle Scholar
  15. Citrin DL, Elson P, DeWys W (1984) Treatment of metastatic prostate cancer: an analysis of response criteria in patients with measurable soft tissue disease. Cancer 54: 13–17PubMedGoogle Scholar
  16. Coleman RE, Whitaker KB, Mashiter G et al. (1986) Assessment of osteoblast activity predicts radiological response in bone metastases from breast cancer (abstr). Proc Am Assoc Cancer Res 27: 180Google Scholar
  17. Condon BR, Buchanan R, Garvle NW et al. (1981) Assessment of progression of secondary bone lesions following cancer of the breast or prostate using serial radionuclide imaging. Br J Radiol 54: 18–23PubMedGoogle Scholar
  18. Constable AR, Cranage RW (1981) Recognition of the superscan in prostatic bone scintigraphy. Br J Radiol 54: 122–125PubMedGoogle Scholar
  19. Dahnert WF, Hamper UM, Eggleston J et al. (1986) Prostatic evaluation by transrectal sonography with histopathologic correlation: the echopenia appearance of early carcinoma. Radiology 158: 97–102PubMedGoogle Scholar
  20. Deftos LJ, Parthemore JG, Price PA (1982) Changes in plasma bone GLA protein during treatment of bone disease. Calcif Tissue Int 34: 121–124PubMedGoogle Scholar
  21. Dequecker J, Mbuyi-Muamba JM, Holvoet G (1983) Hydroxyproline and bone metastasis. In: Stoll BA, Parbhoo S (eds) Bone metastasis: monitoring and treatment. Raven Press, New York, pp 181–199Google Scholar
  22. DeWys WD, Begg CB, Brodowsky H et al. (1983) A comparative clinical trial of adriamycin and 5- fluorouracil in advanced prostatic cancer: prognostic factors and response. Prostate 4: 1–11.PubMedGoogle Scholar
  23. Dexeus F, Logothetis C, Hossan R et al. (1984) Phase II study of vinblastine (Vlb) in advanced hormone resistant metastatic prostate cancer ( HPC ). Proc Am Soc Clin Oncol 3: 161Google Scholar
  24. Drago JR, Santen RJ, Lipton A et al. (1985) Clinical effect of aminoglutethimide, medical adrenalectomy, in treatment of 43 patients with advanced prostatic carcinoma. Cancer 53: 1447–1450Google Scholar
  25. Eagen RT, Hahn RG, Myers RR (1976) Adriamycin (NSC-123127) vérsus 5-fluorouracil (NSC- 19893) and cyclophosphamide (NSC-26271) in the treatment of metastatic prostate cancer. Cancer Treat Rep 60: 115–117Google Scholar
  26. Eisenberger M, Simon R, O’Dwyer P, Wittes R, Friedman M (1985) A reevaluation of nonhormonal cytotoxic chemotherapy in the treatment of prostatic carcinoma. J Clin Oncol 3: 827–841PubMedGoogle Scholar
  27. Eisenberger MA, O’Dwyer PJ, Friedman MA (1986) Gonadotropin hormone-releasing hormone analogues: a new therapeutic approach for prostatic carcinoma. J Clin Oncol 4: 414–424PubMedGoogle Scholar
  28. Ekman P, Svennerus K, Zetterberg A et al. (1981) Cytophotometric analysis and steroid receptor content in human prostatic carcinoma. Scand J Urol Nephrol [Suppl] 60: 85–88Google Scholar
  29. Elder JS, Gibbons RP (1985) Results of trials of the USA National Prostatic Cancer Project. Schroeder F, Richards B (eds) Therapeutic principles in metastatic prostatic cancer. Alan R. Liss, Inc., New York pp 221–242 (EORTC Genitourinary Group Monograph 2, part A)Google Scholar
  30. Emrich L, Priore R, Murphy GP et al. (1985) Prognostic factors in patients with advanced stage prostate cancer. Cancer Res 45: 5173–5179PubMedGoogle Scholar
  31. English HF, Drago JR, Santen RJ (1986a) Cellular response to androgen depletion and repletion in the rat ventral prostate: autoradiography and morphometric analysis. Prostate 7: 41–51.Google Scholar
  32. English HF, Kloszewski E, Valentine E, Santen RJ (1986b) Proliferative response of the Dunning R3327H experimental model of prostatic adenocarcinoma to conditions of androgen depletion and repletion. Cancer Res 46: 839–844PubMedGoogle Scholar
  33. Epstein S, Poser J, McClintock R, Johnston C, Bryce G, Hui S (1984) Differences in serum bone GLA protein with age and sex. Lancet 1: 307–310PubMedGoogle Scholar
  34. Erol D, Adalar N, Guvencli S, Simsek F (1983) Urinary hydroxyproline levels in patients with prostatic carcinoma. Int Urol Nephrol 15: 267–274PubMedGoogle Scholar
  35. Fleming I (1982) One sample multiple testing procedures for phase II clinical trials. Biometrics 38: 143–151PubMedGoogle Scholar
  36. Fogelman I (1980) Skeletal uptake of diphosphate: a review. Eur J Nucl Med 5: 473–476PubMedGoogle Scholar
  37. Fowler JE, Whitmore EF (1982) Considerations for the use of testosterone with systemic chemotherapy in prostatic cancer. Cancer 49: 1373–1377PubMedGoogle Scholar
  38. Freiha FS, Lum BL, Spaulding J et al. (1985) Does response to chemotherapy in patients with bidimensional prostate metastases reflect tumor response in skeletal metastases? Proc Am Soc Clin Oncol 4: 102Google Scholar
  39. Galasko CSB (1975) The pathological basis for skeletal scintigraphy. J Bone Joint Surg 578: 353–359Google Scholar
  40. Gehan E (1961) The determination of the number of patients required in a follow up trial of a new chemotherapeutic agent. J Chron Dis 13: 346–353PubMedGoogle Scholar
  41. Geller J, Albert J (1985) DHT in prostate cancer tissue—a guide to management and therapy. Prostate 6: 19–25PubMedGoogle Scholar
  42. Gibbons RP, Beckley S, Brady MF et al. (1983) The addition of chemotherapy to hormonal therapy for treatment of patients with metastatic carcinoma of the prostate. J Surg Oncol 23: 133–142PubMedGoogle Scholar
  43. Glatstein E, Makuch R (1984) Illusion and reality: practical pitfalls in interpreting clinical trials. J Clin Oncol 2: 488–497PubMedGoogle Scholar
  44. Glode L, Max D et al. Leoprolide (1983) (D-Leu6-DesGly10-Pro9-NH Et-LHRH) in the therapy of advanced prostatic carcinoma. 13th Int Cong Chemotherapy 12.1.8.A Section 242: 49–52Google Scholar
  45. Groot C, Blak J (1984) Electron microscopical demonstration of osteocalcin antigenicity in fetal rat bone. Am Soc Bone Mineral Res 6: 12Google Scholar
  46. Guinan P (1981) What is the best test to detect prostate cancer? CA 141–146Google Scholar
  47. Gundberg CM, Lian JB, Gallop PM, Steinberg JJ (1983) Urinary gamma-carboxyglutamic acid and serum osteocalcin as bone markers: studies in osteoporosis and Paget’s disease. J Clin Endocrinol Metab 57: 1221–1225PubMedGoogle Scholar
  48. Harper ME, Pierrepoint CG, Griffiths K (1984) Carcinoma of the prostate: relationship of pretreatment hormone levels to survival. Eur J Cancer Clin Oncol 20: 477–482PubMedGoogle Scholar
  49. Heller W, Harzmann R, Bickler R, Schmidt K (1979) Urinary hydroxyproline in healthy patients and in patients with and without bone metastases. Curr Probl Clin Biochem 9: 249–258PubMedGoogle Scholar
  50. Herr H, Kleinert E, Relyea N, Whitmore W (1984) Potentiation of methylglyoxal bisguanylhydrazone by alpha-difluromethylornithine in rat prostate cancer. Cancer 53: 1294–1298PubMedGoogle Scholar
  51. Hopkins S, Nissenkorn I, Palmieri G et al. (1983) Serial spot hydroxyproline/creatinine ratios in metastatic prostatic cancer. J Urol 129: 319–323PubMedGoogle Scholar
  52. Hopkins S, Palmieri G, Niell H et al. (1984) Total and nondialyzable hydroxyproline excretion in stage D2 prostate cancer. Cancer 53: 117–121PubMedGoogle Scholar
  53. Hsu DS, Babaian RJ (1983) 5-Fluorouracil, Adriamycin, mitomycin-C ( FAM) in the treatment of hormonal-resistant stage D adenocarcinoma of the prostate (abstr ). Proc Am Soc Clin Oncol 2: 133Google Scholar
  54. Ihde D, Bunn PA, Cohen MH et al. (1980) Effective treatment of hormonally-unresponsive metastatic carcinoma of the prostate with adriamycin and cyclophosphamide: methods of documenting tumor response and progression. Cancer 45: 1300–1310PubMedGoogle Scholar
  55. Ihde DC, Bunn PA, Cohen MH et al. (1981) Combination chemotherapy as initial treatment for stage D-2 prostatic cancer: response rate and results of subsequent hormonal therapy. Proc Am Assoc Cancer Res 22: 163Google Scholar
  56. Ihde DC, Belville WD, Mahan DE et al. (1982) Serum acid phosphatase in the assessment of response to systemic therapy in metastatic prostate cancer: comparison of radioimmune and enzymatic assays. Milit Med 147: 949–952Google Scholar
  57. Isaacs JT (1985) New principles in the management of metastatic prostatic cancer. Schroeder F, Richards B (eds) Therapeutic principles in metastatic prostatic cancer. Alan R. Liss, New York, pp 383–405 (EORTC Genitourinary Group Monograph 2, part A)Google Scholar
  58. Isaacs JT, Coffey DS (1982) Adaptation vs. selection as the mechanism responsible for the relapse of prostatic cancer to androgen therapy as studied in the Dunning R-3327-H adenocarcinoma. Cancer Res 42: 2353–2361PubMedGoogle Scholar
  59. Jacobs S (1983) Spread of prostatic cancer to bone. Urology 21: 337–342PubMedGoogle Scholar
  60. Jones WG, Members of the EORTC GU Group (1985) EORTC Phase II chemotherapy studies in prostate cancer. Schroeder F, Richards B (eds) Therapeutic principles in metastatic prostatic cancer. Alan R. Liss, New York, pp 435–447 (EORTC Genitourinary Group Monograph 2, part A)Google Scholar
  61. Kaplan LA, Chen IW, Sperling M, Bracken B, Stein E (1985) Clinical utility of serum prostatic acid phosphatase measurements for detection (screening), diagnosis, and therapeutic monitoring of prostatic carcinoma; assessment of monoclonal and polyclonal enzymes and radioimmunoassays. Am J Clin Pathol 84: 334–339PubMedGoogle Scholar
  62. Kasimis B, Miller B, Kaneshiro C et al. (1985) Cyclophosphamide versus 5-fluorouracil, doxorubicin, and mitomycin C (FAM’) in the treatment of hormone resistant metastatic carcinoma of the prostate: a preliminary report of a randomized trial. J Clin Oncol 3: 385–392PubMedGoogle Scholar
  63. Khansur T, Yam L, Tavassoli M (1983) Serum monitors of bone metastasis. In: Stoll BA, Parbhoo S (eds) Bone metastasis: monitoring and treatment. Raven Press, New York, pp 165–181Google Scholar
  64. Killian C, Yuang N, Emrich L et al. (1985) Prognostic importance of prostate-specific antigen for monitoring patients with stages B2 to D1 prostate cancer. Cancer Res 45: 886–891PubMedGoogle Scholar
  65. Killian C, Emrich L, Vargas, F et al. (1986) Relative reliability of five serially measured markers for prognosis of progression in prostate cancer. J Natl Cancer Inst 76: 179–185PubMedGoogle Scholar
  66. Kuriyama M, Wang MC, Lee CI et al. (1982) Multiple marker evaluation in prostate cancer using tissue specific antigens. J Natl Cancer Inst 68: 99–105PubMedGoogle Scholar
  67. Labrie F, Dupont A, Belanger A (1985) Complete androgen blockade for treatment of prostate cancer. In: DeVita VT, Hellman S, Rosenberg SA (eds) Important advances in oncology. J.P. Lippincott, Philadelphia, pp 193–217Google Scholar
  68. Langhammer K, Sintermann R, Hor G, Pabst HW (1978) Serial bone scintigraphy for assessing the effectiveness of treatment of osseous metastases from prostatic cancer. Nucl Med 17: 87–91Google Scholar
  69. Levenson RM, Sauerbrunn BJL, Bates HR et al. (1983) Comparative value of bone scintigraphy and radiography in monitoring tumor response in systemically treated prostatic carcinoma. Radiology 146: 513–518PubMedGoogle Scholar
  70. Lewenhaupt A, Ekman P, Eneroth P (1985) Tissue polypeptide antigen ( TPA) as a prognostic aid in human prostatic carcinoma. Prostate 6: 285–291PubMedGoogle Scholar
  71. Loening SA, Scott WW, Dekernion J et al. (1981) A comparison of hydroxyurea, methyl- chloroethyl-chlorohexyl-nitrosourea and cyclophosphamide in patients with advanced prostate cancer. J Urol 125: 812–816PubMedGoogle Scholar
  72. Logothetis CJ, von Eschenbach AC, Samuels ML et al. (1982) Doxorubicin, mitomycin and 5- fluorouracil (DMF) in the treatment of hormone-resistant stage D prostate cancer. A preliminary report. Cancer Treat Rep 66: 57–63Google Scholar
  73. Logothetis CJ, Samuels ML, von Eschenbach AC et al. (1983) Doxorubicin, mitomycin-C, and 5- fluorouracil ( DMF) in the treatment of metastatic hormonal refractory adenocarcinoma of the prostate, with a note on staging of metastatic prostate cancer. J Clin Oncol 1: 368–37PubMedGoogle Scholar
  74. Lowenthal D, Scher H, Geller N et al. (1986) Osteocalcin (OC) as a marker of bone turnover in prostatic cancer ( PC) (abstr ). Proc Am Assoc Cancer Res 27: 160Google Scholar
  75. Manni A, Santen R, Boucher A et al. (1986) Androgen priming and response to chemotherapy in advanced prostate cancer (abstr). Proc Am Soc Clin Oncol 5: 96Google Scholar
  76. Mantel N, Byar DP (1974) Evaluation of response-time data involving transient states: an illustration using heart-transplant data. JASA 69: 81–91Google Scholar
  77. Markowitz M, Gundberg C, Rosen J (1984) 24 hour fluctuations in serum osteocalcin concentration in women. Am Soc Bone Mineral Res 6: 17Google Scholar
  78. Mee AD, Khan O, Mashiter K (1984) High serum prolactin associated with poor prognosis in carcinoma of the prostate. Br J Urol 56: 698–701PubMedGoogle Scholar
  79. Mettlin C (1983) Epidemiology of prostate cancer in different population groups. Clin Oncol 2: 187–192Google Scholar
  80. Meyhoff HH, Ingemann L, Nordling J, Hald T (1981) Accuracy in preoperative estimation of prostatic size. Scand J Urol Nephrol 15: 45–51PubMedGoogle Scholar
  81. Mittal R, Korval C, Starzl T et al. (1983) Accuracy of computerized tomography (CT) in determining hepatic tumor size in patients ( PTS) receiving liver transplants or resection. Proc Am Soc Clin Oncol 2: 121Google Scholar
  82. Moertel C, Hanley J (1976) The effect of measuring error on the results of therapeutic trials in advanced cancer. Cancer 38: 388–394PubMedGoogle Scholar
  83. Moopan M, Wax S, Kim H et al. (1980) Urinary hydroxyproline excretion as a marker of osseous metastasis in carcinoma of the prostate. J Urol 123: 694–696Google Scholar
  84. Mooppan U, Kim H, Wang J, Tobin M, Wax S (1983) Use of urinary hydroxyproline excretion as a tumor marker in diagnosis and follow-up of prostate cancer. Prostate 4: 397–402Google Scholar
  85. Moore MR, Graham SO, Birch R, Irwin L (1987) Phase II evaluation of mitoguazone in metastatic hormone resistant prostate cancer: a Southeastern Cancer Group study trial. Cancer Treat Rep 71: 89–90PubMedGoogle Scholar
  86. Mundy A (1979) Urinary hydroxyproline excretion in carcinoma of the prostate. A comparison of 4 different modes of assessment and its role as a marker. Br J Urol 51: 570–579PubMedGoogle Scholar
  87. Nagel R, Borgmann V, Al-Ahabi H et al. (1983) Premiers resultats cliniques concernant le traitement du cancer de la prostate a un stade local avance au moyen d’un puissant analogue de la LHRH: l’acetate de busereline. J Urol 89: 669–676Google Scholar
  88. Nesbit RM, Baum WC (1950) Endocrine control of prostatic carcinoma: clinical and statistical survey of 1818 cases. JAMA 143: 1317–1320Google Scholar
  89. Nissenkorn I, Mickey D, Miller D et al. (1982) Circadian and day to day variation of prostatic acid phosphatase. J Urol 128: 1122–1124Google Scholar
  90. O’Bryan RM, Baker LH, Gorttleib JF et al. (1977) Dose response evaluation of Adriamycin in human neoplasia. Cancer 39: 1940–1948PubMedGoogle Scholar
  91. Pabst HW, Langhammer H, Bauer R (1983) Technical problems in assessing bone scans. In: Stoll BA, Parbhoo S (eds) Bone metastasis: monitoring and treatment. Raven Press, New York, pp 85–106Google Scholar
  92. Page JP, Levi JA, Woods RL et al. (1985) Randomized trial of combination chemotherapy in hormone resistant metastatic prostatic carcinoma. Cancer Treat Rep 69: 105–107PubMedGoogle Scholar
  93. Pappas A, Gadsden RH (1984) Prostatic acid phosphatase: clinical utility in detection, assessment, and monitoring carcinoma of the prostate. Ann Clin Lab Sci 14: 285–291PubMedGoogle Scholar
  94. Parbhoo S (1983) Serial scintiscans in monitoring patients with bone metastasis. In: Stoll BA, Parbhoo S (eds) Bone metastasis: monitoring and treatment. Raven Press, New York, pp 201–237Google Scholar
  95. Paulsen D, Berry W, Cox E et al. (1979) Treatment of metastatic endocrine unresponsive carcinoma of the prostate gland with multi-agent chemotherapy: indicators of response to treatment. J Natl Cancer Inst 63: 615–622Google Scholar
  96. Peto R, Pike MC, Armitage NE et al. (1977) Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Part II. Analysis and examples. Br J Cancer 35: 1–39Google Scholar
  97. Pollard M, Luckert PH (1985) Prostate cancer in a Sprague-Dawley rat. Prostate 6: 389–393PubMedGoogle Scholar
  98. Pollen J, Gerber K, Ashbum W et al. (1981) The value of nuclear bone imaging in advanced prostatic cancer. J Urol 125: 222–223PubMedGoogle Scholar
  99. Pollen JJ, Reznek R, Tolner LB (1984a) Lysis of osteoblastic lesions in prostatic cancer: a sign of progression. AJR 142:1175–1177 Pollen JJ, Witztum K, Ashburn WL (1984b) The flare phenomenon on radionuclide bone scan in metastatic prostatic cancer. AJR 142: 773–776PubMedGoogle Scholar
  100. Pontes JE (1983) Biological markers in prostate cancer. J Urol 130: 1037–1047PubMedGoogle Scholar
  101. Pontes JE, Chu TM, Slack N et al. (1978) Serum prostatic antigen measurement in localized prostatic cancer: correlation with clinical course. J Urol 128: 1216–1218Google Scholar
  102. Pretlow TG, Harris BE, Bradley EC et al. (1985) Enzyme activities in prostatic carcinoma related to Gleason grades. Cancer Res 45: 442–446PubMedGoogle Scholar
  103. Price P, Otsuka A, Poser J, Kristaponis J, Raman N (1975) Characterization of a gamma- carboxyglutamic acid-containing protein from bone. Proc Natl Acad Sci 5: 1447–1451Google Scholar
  104. Queich K, Cole W, Melick R (1984) Noncollagenous proteins in normal and pathological human bone. Calcif Tissue Int 36: 454–462Google Scholar
  105. Richards B (1984) Clinical significance and statistical significance. In: Denis L, Murphy GP, Prout GR, Schroeder F (eds) Controlled clinical trials in urology. Raven Press, New York, pp 17–18Google Scholar
  106. Rifkin MD, Friedland GW, Shortliffe L (1986) Prostatic evaluation by transrectal endosonography: detection of carcinoma. Radiology 158: 85–90PubMedGoogle Scholar
  107. Rinsho K, Aoyagi K (1982) Urinary hydroxyproline excretion as a marker of bone metastases in prostatic cancer. Tohoku J Exp Med 137: 461–467PubMedGoogle Scholar
  108. Saiers JH, Trannum BL, Stephens R, Crawford ED (1985) Treatment of stage Dil adenocarcinoma of the prostate with doxorubicin, mitomycin C and 5-fluorouracil (DMF): a Southwest Oncology Group study. Proc Am Soc Clin Oncol 4: 108Google Scholar
  109. Saitoh H, Hida M, Shimbo T et al. (1984) Metastatic patterns of prostatic cancer: correlation between sites and number of organs involved. Cancer 54: 3078–3084PubMedGoogle Scholar
  110. Sandhu RS, Conover RE (1980) Usually high creatine kinase BB isoenzyme and study of lactate dehydrogenase pattern in metastatic adenocarcinoma of the prostate. Clin Biochem 13: 30–33PubMedGoogle Scholar
  111. Schacht MJ, Garnett JE, Grayhack JT (1984) Biochemical markers in prostatic cancer. Urol Clin North Am 11: 253–257PubMedGoogle Scholar
  112. Scher H (1983) Memorial Hospital CIC Protocol 82–54. Ethane hydroxy 1, 1-diphosphonate in the treatment of bone metastases from prostatic cancer.Google Scholar
  113. Scher H (1985) Memorial Hospital Protocol 85-25. Phase I-II trial of difluoromethylornithine (DFMO) and mitoguazone (MGBG) in hormone resistant bidimensionally measurable prostatic cancer.Google Scholar
  114. Scher H, Sternberg CN (1985) Chemotherapy of urologic malignancies. Semin Urol 3: 329–381Google Scholar
  115. Scher H, Yagoda A, Watson R et al. (1984) Phase II evaluation of adriamycin in bidimensionally measurable prostatic adenocarcinoma. J Urol 131: 1099–1102PubMedGoogle Scholar
  116. Scher H, Tauer K, Alcock N et al. (1985a) Preliminary evaluation of gallium nitrate (GaN) on bone turnover and antitumor activity in patients ( Pts) with hormone resistant prostatic cancer metastatic to bone. Proc Am Soc Clin Oncol 4: 104Google Scholar
  117. Scher H, Yagoda A, Ahmed T et al. (1985b) Phase II trial of mitoguazone in bidimensionally measurable hormone resistant adenocarcinoma of the prostate. J Clin Oncol 3: 224–227PubMedGoogle Scholar
  118. Scher H, Geller N, Muggia F, Rozencweig M (1986) Clinical evaluation of anticancer treatment: Phase II clinical trials. In: Muggia F, Rozencweig M (eds) Clinical evaluation of anticancer therapy. Martinus Nijhoff, Boston, pp 175–197Google Scholar
  119. Schipper H, Clinch J, McMurray A et al. (1984) Measuring the quality of life of cancer patients: the functional living index—cancer: development: and validation. J Clin Oncol 2: 472–483PubMedGoogle Scholar
  120. Schmidt JD, Johnson DE, Scott WW et al. (1976) Chemotherapy of advanced prostatic cancer. Evaluation of response parameters. Urology 7: 602–610PubMedGoogle Scholar
  121. Schmidt JD, Scott WW, Gibbons RP et al. (1979) Comparison of procarbazine, imidazole- carbamide and cyclophosphamide in relapsing patients with advanced carcinoma of the prostate. J Urol 121: 185–189PubMedGoogle Scholar
  122. Schroeder FH and the European Organization on Research on Treatment of Cancer Urological Group (1984) Treatment response critieria for prostatic cancer. Prostate 5: 181–191Google Scholar
  123. Scott WW, Gibbons RP, Johnson DE et al. (1976) The continued evaluation of the effects of chemotherapy in patients with advanced carcinoma of the prostate. J Urol 116: 211–213PubMedGoogle Scholar
  124. Seifter E, Bunn P, Cohen M et al. (1986) Combination chemotherapy followed by hormonal therapy for previously untreated metastatic carcinoma of the prostate. Proc Am Assoc Cancer Res 27: 183Google Scholar
  125. Selby P, Chapman JA, Etazadi-Amoli J et al. (1984) The development of a method for assessing quality of life in cancer. Br J Cancer 50: 13–22PubMedGoogle Scholar
  126. Seppanen P, Alhonen-Hongisto L, Janne J (1981) Polyamine deprivation-induced enhanced uptake of methylglyoxal bis (guanylhydrazone) by tumor cells. Biochim Biophys Acta 674:169 Silverberg E (1985) Cancer statistics, CA 35: 19–35Google Scholar
  127. Simon R (1985) Design and conduct of clinical trials. In: DeVita VT, Hellman S, Rosenberg SA (eds) Principles and practice of oncology. J.P. Lippincott, Philadelphia, pp 329–350Google Scholar
  128. Simon R, Wittes R, Ellenberg S (1985) Randomized phase II clinical trials. Cancer Treat Rep 69: 1375–1381PubMedGoogle Scholar
  129. Slack MH, Mittleman A, Brady MF, Murphy GP (1980) The importance of the stable category for chemotherapy treated patients with advanced and relapsing prostate cancer. Cancer 46: 2393–2402PubMedGoogle Scholar
  130. Slack N, Brady M, Murphy G et al. (1985) Stable versus partial response in advanced prostate cancer. Prostate 5: 401–415Google Scholar
  131. Slack N, Lane W, Prior R, Murphy GP (1986) Prostatic cancer: treated at a categorical center, 1980–1983. Urology 27: 205–213PubMedGoogle Scholar
  132. Tannock IF (1985) Is there evidence that chemotherapy is of benefit to patients with carcinoma of the prostate? J Clin Oncol 3: 1013–1020PubMedGoogle Scholar
  133. Tannock I, Murphy K (1983) Reflections in medical oncology: an appeal for better clinical trials and improved reporting of their results. J Clin Oncol 1: 66PubMedGoogle Scholar
  134. Termine JD, Kleinman HK, Whitson SW et al. (1981) Osteonectin, a bone-specific protein linking mineral to collagen. Cell 26: 99–104PubMedGoogle Scholar
  135. Tonkin K, Tritchler D, Tannock I (1985) Criteria of tumor response used in clinical trials of chemotherapy. J Clin Oncol 3: 870–875PubMedGoogle Scholar
  136. Torti F, Lum B (1985) Chemotherapy in prostate cancer. In: Garnick MB (ed) Genitourinary cancer. Churchill Livingstone, New York, pp 125–161Google Scholar
  137. Torti F, Aston D, Lum BL et al. (1983) Weekly doxorubicin in endocrine refractory carcinoma of the prostate. J Clin Oncol 1: 377–384Google Scholar
  138. Torti FM, Martin BC, Higgins MC et al. (1984) Skeletal metastases of prostatic carcinoma can subserve the function of measurable sites in prostatic cancer trials. Proc Am Soc Clin Oncol 4: 103Google Scholar
  139. Torti F, Shortliffe L, Carter S (1985) A randomized study of doxorubicin versus doxorubicin plus cisplatin in endocrine-unresponsive metastatic prostatic carcinoma. Cancer 56: 2580–2586PubMedGoogle Scholar
  140. Torti FM, Flam M, Lum BL (1985) Weekly adriamycin and methotrexate in endocrine unresponsive carcinoma of the prostate. Proc Am Soc Clin Oncol 4: 103Google Scholar
  141. Trachtenberg J (1984) Ketoconazole therapy in advanced prostatic cancer. J Urol 132: 61–63PubMedGoogle Scholar
  142. Trachtenberg J, Walsh PC (1982) Correlation of prostatic nuclear androgen receptor content with duration of response and survival following hormonal therapy in advanced prostatic cancer. J Urol 127: 466–471PubMedGoogle Scholar
  143. University of Maryland Cancer Center Protocol #85-25 (1985) A phase II study of trimetrexate in endocrine resistant prostatic prostatic carcinoma.Google Scholar
  144. Warr D, McKinney S, Tannock I (1984) Influence of measurement error on assessment of response to anticancer chemotherapy: proposal for new criteria for tumor response. J Clin Oncol 2: 1040–1046PubMedGoogle Scholar
  145. Whitmore WF (1973) The natural history of prostatic cancer. Cancer 32: 1104–1112PubMedGoogle Scholar
  146. Wittes RE, Marsoni S, Simon R, Leyland-Jones BR (1985) The phase II trial. Cancer Treat Rep 69: 1235–1239PubMedGoogle Scholar
  147. Yagoda A (1983) Response in prostatic cancer: an enigma. Semin Urol 1: 311–323PubMedGoogle Scholar
  148. Yagoda A, Watson RC, Natale RB et al. (1979) A critical analysis of response criteria in patients with prostatic cancer treated with cis-diamminedichloride platinum II. Cancer 44: 1553–1562PubMedGoogle Scholar
  149. Zelen M (1975) Importance of prognostic factors in planning therapeutic trials. In: Staquet M (ed) Cancer therapy: prognostic factors and criteria of response. Raven Press, New York, pp 1–15Google Scholar
  150. Zweig M, Ihde D (1985) Assessment of serum and enzymatic prostatic acid phosphatase and radioimmune creatine kinase BB for monitoring response to therapy in metastatic prostatic carcinoma. Cancer Research 45: 3945–3952PubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1987

Authors and Affiliations

  • H. I. Scher
  • A. Yagoda

There are no affiliations available

Personalised recommendations