BXL628, a novel vitamin d3 analog arrests prostate growth in patients with benign prostatic hyperplasia: A randomized clinical trial

Enrico Colli, Patrizio Rigatti, Francesco Montorsi, Walter Artibani, Stefano Petta, Nicola Mondaini, Roberto Scarpa, Paolo Usai, Lorenza Olivieri, Mario Maggi, P. Rigatti, W. Artibani, E. Belgrano, M. Carini, F. Catanzaro, V. Mirone, S. Petta, M. Rizzo, R. Scarpa, E. UsaiR. Zucconelli

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To evaluate the effect of BXL628, a vitamin D3 analog, on prostate volume in patients with benign prostatic hyperplasia (BPH). Methods: We conducted a phase II, double blind, randomized, placebo controlled, clinical study. Patients eligible were aged ≥50 years, had a diagnosis of BPH and a prostate volume ≥40 ml. Eligible patients were randomized and given either BXL628 150 mcg daily or placebo for 12 weeks. All randomized patients underwent at baseline and at the end of study pelvic MRI to measure prostatic volume, uroflowmetry (Q max), American Urological Association Symptom Index (AUASI), serum PSA, testosterone, dihydrotestosterone and luteizing hormone. Results: A total of 119 patients were randomized: 57 patients to BXL628 and 62 to placebo. The percentage change of prostate volume at 12 week was -2.90 in the BXL628 group vs. +4.32 in the placebo group (p-value max, mean change vs. baseline was -0.30 in BXL628 vs. +1.50 in the placebo group: this finding was not statistically significant. The mean change of the AUASI total score at final visit vs. baseline was -1.77 in the BXL628 group vs. -3.45 in the placebo group (p= not significant). Conclusion: BXL628 was able to arrest prostate growth within 12 weeks in men aged ≥50 years with prostatic volume ≥40 ml. Its unprecedented mechanism of action may offer a new opportunity for the treatment of BPH.

Original languageEnglish
Pages (from-to)82-86
Number of pages5
JournalEuropean Urology
Volume49
Issue number1
DOIs
Publication statusPublished - Jan 2006

Keywords

  • BXL628
  • Prostate
  • Vitamin D3

ASJC Scopus subject areas

  • Urology

Fingerprint Dive into the research topics of 'BXL628, a novel vitamin d3 analog arrests prostate growth in patients with benign prostatic hyperplasia: A randomized clinical trial'. Together they form a unique fingerprint.

Cite this