title: [Three-year follow-up of 12 patients with prostate cancer treated with monthly degarelix in a phase II clinical trial].
abstract: The efficacy and safety of degarelix, a luteinizing hormone-releasing hormone(LH-RH)antagonist, in patients with prostate cancer(PCa)were evaluated in a phase II, open-label, multicenter clinical trial. In this trial, a total of 13 patients were accrued at the Yamagata Prefectural Central Hospital from 2007 to 2008. The median age was 80 years(range, 65-85 years), and clinical stages were T1c, T2, T3, and T4 in 1, 4, 6, and 2 patients, respectively. Nodal(N)status was N0 in 9 patients and N1 in 4 patients. Distant metastases were absent(M0)in 12 patients and present(M1b)in 1 patient. The median prostate- specific antigen(PSA)level was 29.1 ng/mL(range, 6.3-427 ng/mL). All but one patient, who died of an unrelated cause, received a monthly dose(80 or 160mg)of degarelix for 12 months and were followed-up for 3 years. The PSA level declined in all patients. One patient died of an unrelated cause during the phase II trial. After completion of the phase II trial, 5 patients were treated with combined and rogen blockade(CAB)(leuprolide plus anti-androgen therapy), 2 patients were treated with single-agent leuprolide, 2 patients received single-agent bicalutamide, and 1 patient was followed-up without additional treatment. Radical prostatectomy was performed in 2 patients. Among the 5 patients treated with CAB, 2 died of metastatic cancer. CAB was effective in suppressing PSA levels in 3 patients. In 1 patient with T3aN1M1b PCa, colon cancer with lung metastases was detected during the follow-up period. Treatment with chemotherapy for colon cancer was effective in suppressing PSA levels for 12 months. In 1 patient with cT3aN1M0 PCa, the PSA level declined to <0.02 ng/mL, and a reduction in size of the prostate gland and metastatic lymph nodes was observed. This effect persisted for 3.5 years after the completion of the 12-month degarelix regimen, and no additional treatment was required.
authors.affiliation: Dept. of Urology, Yamagata Prefectural Central Hospital.
authors.forename: Senji
authors.initials: S
authors.lastname: Hoshi
authors.forename: Natsuho
authors.initials: N
authors.lastname: Hayashi
authors.forename: Mayu
authors.initials: M
authors.lastname: Yagi
authors.forename: Teppei
authors.initials: T
authors.lastname: Ookubo
authors.forename: Akinori
authors.initials: A
authors.lastname: Muto
authors.forename: Osamu
authors.initials: O
authors.lastname: Sugano
authors.forename: Kenji
authors.initials: K
authors.lastname: Numahata
authors.forename: Vladimir
authors.initials: V
authors.lastname: Bilim
authors.forename: Kiyotugu
authors.initials: K
authors.lastname: Hoshi
authors.forename: Isoji
authors.initials: I
authors.lastname: Sasagawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000037:antagonists & inhibitors; D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D009842:Oligopeptides / Q000008:administration & dosage / Q000627:therapeutic use*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D009842:Oligopeptides; C431566:acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; D007987:Gonadotropin-Releasing Hormone; D017430:Prostate-Specific Antigen