A six-month, open-label study assessing a new formulation of leuprolide 7.5 mg for suppression of testosterone in patients with prostate cancer

Clinical Therapeutics

Volumn 24, Issue 11, 2002, Pages 1902-1914

  Perez Marreno, Ramon ^a   Chu, Franklin M ^b   Gleason, Donald ^c   Loizides, Edward ^d   Wachs, Barton ^e   Tyler, Robert C ^f  

^a Urology Health Center   (United States)

^b San Bernardino Urological Associates   (United States)

^c Advanced Clinical Therapeutics   (United States)

^d Med/Clinical Research Associates   (United States)

^e Atlantic Urology Medical Group   (United States)

^f QLT Inc   (United States)

Author keywords

Clinical trials; Leuprolide; Prostate specific antigen; Prostatic neoplasm; Testosterone

Indexed keywords

ALUMINUM OXIDE; LEUPRORELIN; PROSTATE SPECIFIC ANTIGEN; TESTOSTERONE;

ADULT; AGED; ARTICLE; BURNING SENSATION; CANCER DIAGNOSIS; CANCER STAGING; CLINICAL TRIAL; COLUMN CHROMATOGRAPHY; DRUG EFFICACY; DRUG FORMULATION; DRUG PURIFICATION; DRUG RESPONSE; DRUG SAFETY; FATIGUE; GYNECOMASTIA; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HOT FLUSH; HUMAN; INJECTION SITE; LIBIDO DISORDER; MAJOR CLINICAL STUDY; MALAISE; MALE; MAXIMUM ALLOWABLE CONCENTRATION; OPEN STUDY; PROSTATE ADENOCARCINOMA; PROTEIN BLOOD LEVEL; RADIOIMMUNOASSAY; SOLID PHASE EXTRACTION; TESTIS ATROPHY; TESTOSTERONE BLOOD LEVEL; TESTOSTERONE RELEASE; TREATMENT WITHDRAWAL; VERTIGO;

EID: 0036862243     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(02)80087-X     Document Type: Article

References (18)

1. Landis SH, Murray T, Bolden S, Wingo PA. Cancer statistics, 1999. CA Cancer J Clin. 1999;49:8-31.
2. Huggins C, Hodges CV. Studies on prostate cancer: Effect of castration, estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res. 1941;1:293-297.
3. Tolis G, Ackman D, Stellos A, et al. Tumor growth inhibition in patients with prostatic carcinoma treated with luteinizing hormone-releasing hormone agonists. Proc Natl Acad Sci U S A. 1982;79:1658-1662.
4. Sharifi R, Bruskewitz RC, Gittleman MC, et al. Leuprolide acetate 22.5 mg 12-week depot formulation in the treatment of patients with advanced prostate cancer. Clin Ther. 1996;18:647-657.
5. Sharifi R, Soloway M. Clinical study of leuprolide depot formulation in the treatment of advanced prostate cancer. The Leuprolide Study Group. J Urol. 1990;143:68-71.
6. Tunn UW, Bargelloni U, Cosciani S, et al. Comparison of LH-RH analogue 1-month depot and 3-month depot by their hormone levels and pharmacokinetic profile in patients with advanced prostate cancer. Urol Int. 1998;60(Suppl 1):9-16.
7. Fowler JE Jr, Gottesman JE, Reid CF, et al. Safety and efficacy of an implantable leuprolide delivery system in patients with advanced prostate cancer. J Urol. 2000; 164:730-734.
8. Zubrod CG, Schneiderman M, Frei E III, et al. Appraisal of methods for the study of chemotherapy of cancer in man: Comparative therapeutic trial of nitrogen mustard and triethylene thiophosphamide. J Chronic Dis. 1960;11:7-33.
9. WHO Handbook for Reporting Results for Cancer Treatment. Geneva, Switzerland: World Health Organization; 1979.
10. Bahnson RR, Hanks GE, Huben RP, et al. NCCN practice guidelines for prostate cancer. Oncology (Huntingt). 2000;14:111-119.
11. Millikan R, Logothetis C. Update of the NCCN guidelines for treatment of prostate cancer. Oncology (Huntingt). 1997;11:180-193.
12. Khan MS, O'Brien A. An evaluation of pharmacokinetics and pharmacodynamics of leuprorelin acetate 3M-depot in patients with advanced and metastatic carcinoma of the prostate. Urol Int. 1998;60:33-40.
13. Ravivarapu HB, Moyer KL, Dunn RL. Sustained suppression of pituitary-gonadal axis with an injectable, in situ forming implant of leuprolide acetate. J Pharm Sci. 2000;89:732-741.
14. Plosker GL, Brogden RN. Leuprorelin. A review of its pharmacology and therapeutic use in prostatic cancer, endometriosis and other sex hormone-related disorders. Drugs. 1994;48:930-967.
15. Cook T, Sheridan WP. Development of GnRH antagonists for prostate cancer: New approaches to treatment. Oncologist. 2000;5:162-168.
16. Thompson IM, Zeidman EJ, Rodriguez FR. Sudden death due to disease flare with luteinizing hormone-releasing hormone agonist therapy for carcinoma of the prostate. J Urot. 1990;144:1479-1480.
17. Kienle E, Lubben G. Efficacy and safety of leuprorelin acetate depot for prostate cancer. The German Leuprorelin Study Group. Urol Int. 1996;56(Suppl 1):23-30.
18. Oefelein MG, Cornum R. Failure to achieve castrate levels of testosterone during luteinizing hormone releasing hormone agonist therapy: The case for monitoring serum testosterone and a treatment decision algorithm. J Urol. 2000;164:726-729.