Welcome, this website is intended for international healthcare professionals with an interest in the treatment of Advanced Prostate Cancer. By clicking the link below you are declaring and confirming that you are a healthcare professional

You are here

An open-label, phase 2 trial of bicalutamide dose escalation from 50 mg to 150 mg in men with CAB and castration resistance. A Canadian Urology Research Consortium Study.

Klotz L, Drachenberg D, Singal R, Aprikian A, Fradet Y, Kebabdjian M, Zarenda M, Chin J.

Prostate Cancer Prostatic Dis. 2014 Dec;17(4):320-4. Epub 2014 Sep 2.

Abstract
BACKGROUND:

Bicalutamide is a widely used, relatively non-toxic anti-androgen, particularly when used in combination with androgen deprivation. In men on combined androgen blockade (CAB), the typical dose is 50 mg per day. For men receiving monotherapy with bicalutamide anti-androgen, the dose is 150 mg per day. The objective was to determine the PSA response rate to increasing bicalutamide to 150 mg per day in men who develop castrate-resistant prostate cancer (CRPC) on CAB with goserelin acetate and bicalutamide 50 mg per day.

METHODS:
A national, multicentre, phase 2, open-label study in men on CAB with a rising PSA>2.0. The primary end point of the trial was PSA response at 12 months, defined as a decline by 50% or more compared with baseline value. Partial response was defined as a PSA decline of 10-49%. Secondary end points were duration of PSA response, change in slope of serum PSA, change in ratio of free PSA: total PSA at 3 months, 6 months and 12 months as compared with baseline; duration of the bicalutamide withdrawal response after discontinuation; the rate of cardiovascular events; and toxicity. The study was initially planned to accrue 100 patients, but was closed early due to diminishing accrual.

RESULTS:
Sixty-four patients were accrued; 61 patients received trial treatment and constituted the intention-to-treat (ITT) cohort. 70% were M0. Among 59 evaluable ITT patients, 13 (22%) patients had a >50% PSA decline, 5 (8%) had a decline between 10 and 50%, 4 (7%) had stabilization and 37 (63%) had PSA progression. The median duration was 3.7 months (95% confidence interval of 0.92-6.21 months).

CONCLUSION:
In patients with early biochemical failure on CAB with bicalutamide 50 mg, an increase in dose to 150 mg of bicalutamide resulted in a PSA response of ⩾ 50% in 22% of patients. Toxicity was mild. Bicalutamide dose intensification may benefit a subset of patients with CRPC. We believe this relatively inexpensive approach warrants further evaluation.

Share

E-Alert

Register to be notified when new content is published. Only your name, country and email address needed.

Subscribe »

Latest webcast

ESMO 2016 Symposium webcast

Individualizing treatment in
metastatic prostate cancer: there
is no “one-size-fits-all” approach

EAU 2016 Scientific Programme and Sessions

View the Scientific Programme and Sessions of the 2016 EAU Annual Congress, Munich, Germany.

The editorial independence of the resource centre is mandatory and recognized by the EAU and Elsevier.
The journal articles, videos and statements published on the resource centre have been selected independently and without influence from Elsevier, European Urology Editors or the sponsor and do not necessarily reflect their opinions or views

Search this site

Search form