ASCENT: The androgen-independent prostate cancer study of calcitriol enhancing taxotere

    Research output: Contribution to journalArticle

    42 Citations (Scopus)

    Abstract

    ASCENT, the Androgen-Independent Prostate Cancer (AIPC) Study of Calcitriol Enhancing Taxotere, is a double-blind, placebo-controlled randomized clinical trial designed to determine if DN-101, a high-dose oral formulation of calcitriol designed for cancer therapy, significantly increases the proportion of patients who have >50% reduction in serum prostate-specific antigen (PSA) levels in response to docetaxel. The secondary goals of ASCENT are to evaluate the effect of DN-101 combined with docetaxel on PSA progression-free survival, tumour response rate in measurable disease, tumour progression-free survival, skeletal morbidity-free survival, clinical progression-free survival, and overall survival, and to examine the safety and tolerability of DN-101 combined with docetaxel. ASCENT builds on phase I work showing that weekly dosing allows substantial dose-escalation of calcitriol, the natural ligand for the vitamin D receptor, and on phase II work that suggested that adding weekly high-dose 'pulse' calcitriol may enhance the activity of weekly docetaxel in patients with AIPC. The preclinical rationale for calcitriol and its combination with docetaxel for prostate cancer therapy is reviewed, as are the key clinical trials that led to the development of ASCENT. The ASCENT design and its strengths and limitations are presented.

    Original languageEnglish (US)
    Pages (from-to)508-513
    Number of pages6
    JournalBJU International
    Volume96
    Issue number4
    DOIs
    StatePublished - Sep 2005

    Fingerprint

    docetaxel
    Calcitriol
    Androgens
    Prostatic Neoplasms
    Disease-Free Survival
    Prostate-Specific Antigen
    Neoplasms
    Calcitriol Receptors
    Disease Progression
    Randomized Controlled Trials
    Placebos
    Clinical Trials
    Ligands
    Morbidity
    Safety

    Keywords

    • Calcitriol
    • Prostate cancer
    • Vitamin D

    ASJC Scopus subject areas

    • Urology

    Cite this

    ASCENT : The androgen-independent prostate cancer study of calcitriol enhancing taxotere. / Beer, Tomasz (Tom).

    In: BJU International, Vol. 96, No. 4, 09.2005, p. 508-513.

    Research output: Contribution to journalArticle

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