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


CONCLUSIONS
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.
Division of Urology, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, ROC.
Chien-Chang
CC
Kao
Yen-Hwa
YH
Chang
Tony
T
Wu
Guang-Huan
GH
Sun
Dah-Shyong
DS
Yu
Sun-Yran
SY
Chang
Tai-Lung
TL
Cha
D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D013739:Testosterone / Q000097:blood; D017329:Triptorelin Pamoate / Q000009:adverse effects / Q000627:therapeutic use*
D018931:Antineoplastic Agents, Hormonal; D017329:Triptorelin Pamoate; D013739:Testosterone; D017430:Prostate-Specific Antigen