A prospective, multicenter, open-label trial of zoledronic acid in patients with hormone refractory prostate cancer.
OBJECTIVE
The short-term safety and efficacy of zoledronic acid for the treatment of skeletal metastasis was evaluated in patients with hormone-refractory prostate cancer.


METHODS
A total of 19 hormone-refractory prostate cancer patients with bone metastases were enrolled. All patients received up to six infusions of zoledronic acid (4 mg, given intravenously over 15 minutes, every 3-4 weeks). Safety was assessed by monitoring adverse events and serum creatinine levels. Efficacy was assessed by monitoring skeletal-related events, brief pain inventory score, quality of life score, type of pain medication, and analgesic score. Mean age of patients was 67.3 years (46-86 years), mean time from diagnosis of bone metastases was 27.6 months (0-117 months), and mean time from diagnosis of hormone-refractory disease was 7.5 months (0-26 months).


RESULTS
There was no clinically significant change in serum creatinine levels. Eleven adverse events (musculoskeletal disorders and systemic disorders) in 8 patients were classed as having a possible relationship to study drug. Fifteen patients completed six courses of zoledronic acid infusion. There were no significant changes in the brief pain inventory composite scores, quality of life questionnaire scores or analgesic score. No new skeletal-related events developed during the treatment period.


CONCLUSIONS
Zoledronic acid administered in this study as a 15-minute infusion demonstrated an acceptable and well-known safety profile in patients with refractory prostate cancer with bone metastases. However, prospective placebo- controlled clinical trials are required to elucidate the efficacy of zoledronic acid.
Hong
Sung Joon
SJ
Department of Urology, Urological Science Institute, Yonsei University College of Medicine, 3Ulsan University, Seoul, Korea. sjhong346@yuhs.ac
Cho
Kang Su
KS
Cho
Han Yong
HY
Ahn
Hanjong
H
Kim
Choung-Soo
CS
Chung
Byung Ha
BH
D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D003404:Creatinine / Q000097:blood; D004164:Diphosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D016896:Treatment Outcome; D000077211:Zoledronic Acid
D018931:Antineoplastic Agents, Hormonal; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D003404:Creatinine