Open, multi-center, phase IV study to assess the efficacy and tolerability of triptorelin in Taiwanese patients with advanced prostate cancer.

Abstract

BACKGROUND:

To evaluate the efficacy and safety of administering a 3-month formulation of triptorelin as part of disease management of Taiwanese men with advanced adenocarcinoma of the prostate.

METHODS:

Patients with newly diagnosed, locally advanced, or metastatic adenocarcinoma of the prostate were enrolled in our study, after informed consent was obtained. All patients received bicalutamide 50 mg daily for 28 days, starting 7 days before the first injection of triptorelin. A dosage of 11.25 mg triptorelin was injected on Day 0 (baseline) and repeated on Day 90. Prostate-specific antigen (PSA) and testosterone concentrations were measured on Days 90 and 180.

RESULTS:

A total of 41 patients were enrolled, with a median age of 78 (57-92) years, and a baseline median PSA of 122.69 ng/mL. One patient dropped out of the study, one was excluded in the fourth month due to a protocol violation, and one died 4 months after initiation of treatment as a result of disease progression. In total, 40 men were eligible for Day 90 and 38 men for Day 180 analysis. On Day 90, 97.5% of men had reached castration testosterone concentration ≤0.5 ng/mL, and all men had reached this concentration on Day 180. Serum PSA concentration declined to 10.40 ± 23.42 ng/mL on Day 90 (p = 0.0126) and 11.61 ± 23.93 ng/mL on Day 180 (p = 0.0172). The most frequently seen adverse event was gastrointestinal disturbance, including abdominal pain, diarrhea and constipation. Generally, adverse events were mild and patient manageable.

CONCLUSION:

Triptorelin 11.25 mg is effective in achieving medical castration and lowering PSA concentrations and can maintain its medicinal effect for at least 90 days in Taiwanese men with advanced prostate cancer. This suggests that it can be an effective treatment for advanced prostatic cancer.

• Authors: Chien-Chang Kao, Yen-Hwa Chang, Tony Wu, Guang-Huan Sun, Dah-Shyong Yu, Sun-Yran Chang, Tai-Lung Cha
• Journal: Journal of the Chinese Medical Association : JCMA (J Chin Med Assoc) Vol. 75 Issue 6 Pg. 255-61 (Jun 2012) ISSN: 1728-7731 [Electronic] Netherlands
• PMID: 22721619 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study)
• Copyright: Copyright © 2012. Published by Elsevier B.V.

Chemical References

• Antineoplastic Agents, Hormonal
• Triptorelin Pamoate
• Testosterone
• Prostate-Specific Antigen

Topics

• Adenocarcinoma (blood, drug therapy)
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Hormonal (adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Prostate-Specific Antigen (blood)
• Prostatic Neoplasms (blood, drug therapy)
• Testosterone (blood)
• Triptorelin Pamoate (adverse effects, therapeutic use)