Therapeutics in Active Prostate Cancer Surveillance

Sponsor
CCTU- Cancer Theme
Study ID
NCT03365297
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    240mg (4x60mg) oral tablets daily over a max. of 90 days

Study Details

Testing if short-term use of apalutamide can reduce image defined tumour volumes in men with detectable lesion on multi-parametric Magnetic Resonance Imaging (mpMRI) and being managed by Active Surveillance. The trial will also evaluate the tolerability and side effect profile of men on AS using short term apalutamide and patient acceptability as a therapeutic strategy, as well as determining feasibility of a larger prospective randomised trial of apalutamide.

Key Dates

Start date
Jun 5, 2018
Status verified
Jun 2018
Primary completion
Jul 25, 2019
Completion
Jul 25, 2019

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    apalutamide, 240mg (4x60mg tablets) orally, daily for a max. duration of 90 continuous days.

Primary Outcome Measure

Physiological Response [ Time Frame: over a 90 day treatment period ]

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