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, andT4 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, anda 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.
Written by:
Hoshi S, Hayashi N, Yagi M, Ookubo T, Muto A, Sugano O, Numahata K, Bilim V, Hoshi K, Sasagawa I. Are you the author?
Dept. of Urology, Yamagata Prefectural Central Hospital.
Reference: Gan To Kagaku Ryoho. 2014 Jan;41(1):65-9.
PubMed Abstract
PMID: 24423954
Article in Japanese.
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