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About
This is a phase 3, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for prostate cancer.
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Inclusion and exclusion criteria
INCLUSION CRITERIA
To be included in the trial the patient must:
Have given written informed consent to participate.
Be aged 18 or over.
Have an Eastern Cooperative Oncology Group (ECOG) status 0-2.
Have selected active surveillance as a management option.
Have an MRI detectable lesion with an M score of ≥ 3 using Likert scale OR PI-RADS (version 2.1) reporting criteria. If M score is 3 then lesion size (single or combined) of ≥10mm.
Have prostate cancer from a combination of image guided targeted + systematic biopsies and MRI lesion and biopsy are concordant for a prostate cancer diagnosis.
Not anticipated to require bladder outlet surgery during IMP treatment or for up to 12 months of follow-up.
Meet all of the following clinical laboratory assessment criteria:
Have prostate cancer with any one or more of the following:
EXCLUSION CRITERIA
The presence of any of the following will preclude patient inclusion:
Primary purpose
Allocation
Interventional model
Masking
402 participants in 3 patient groups, including a placebo group
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Central trial contact
Aneta Drozd
Data sourced from clinicaltrials.gov
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