ASPIRE-PCa is an observational study that aims to describe the pattern of care for men with late-stage prostate cancer (PC). 1200 patients (pts) from the Americas, Europe, Asia, and the Middle East/North Africa are targeted for enrolment. We present updated data from December 2015.
Men with prostate adenocarcinoma enrol at the diagnosis of: biochemical failure after curative-intent therapy with a prostate-specific antigen (PSA) doubling time of ≤1 year; castration-resistant PC (CRPC); or metastatic PC (mPC) at initial presentation. Initial treatment decision and planned follow-up data were collected.
507 pts have enrolled from 72 sites in 21 countries: Americas, n = 53; Europe, n = 172; Asia, n = 271; and the Middle East/North Africa, n = 11. Biochemical failure, n = 90 (18%); CRPC, n = 181 (36%); mPC, n = 235 (46%); and missing, n = 1 (100%, as >1 option/pt). Enzalutamide was less frequently chosen (n = 7; 3%). The most favoured follow-up was PSA testing every 3 months. Updated regional differences will be presented.
|New treatment,a n (%)
|Chemotherapy, immunotherapy, targeted therapy
|Androgen-deprivation therapy, n (%)
|GnRH agonist and anti-androgen
|GnRH agonist alone
|2nd-generation androgen-directed therapy
|GnRH antagonist alone
|GnRH antagonist and anti-androgen
The updated results from ASPIRE-PCa indicate that most late-stage PC pts receive ADT as a GnRH agonist/aa combination; disease status drives treatment choice; and the most common follow-up is PSA testing every 3 months. Leuprolide and bicalutamide are the most common initial interventions.
Clinical trial identification
NCT02066961 - First received: February 18, 2014; Last updated: February 4, 2016
Legal entity responsible for the study
Astellas Pharma, Inc.
Astellas Pharma, Inc.
N.W. Clarke: Advisory boards for Astellas, AstraZeneca, Bayer, Ferring, Janssen, Ipsen, Sanofi Aventis and Pfizer.
M. De Santis, S. Bazarbashi: The author discloses that they are a member of the ASPIRE steering comitee and have received a research grant from Astellas Pharma Inc.
T. Pickles: The author discloses that they have a substantive relationship with Sanofi Aventis and Oncurra.
G.P. Haas: The author discloses that they are the senior medical director at Astellas Pharma Inc.
M.R. Cooperberg: Employee of Astellas Pharma, Inc.
All other authors have declared no conflicts of interest.