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Therapeutics in Active Prostate Cancer Surveillance

NCT03365297 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-11-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Apalutamide

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

Sponsors & Collaborators

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • CCTU- Cancer Theme

    lead OTHER

Principal Investigators

  • Vincent J Gnanapragasam · Cambridge University Hospitals NHS Foundation Trust/University of Cambridge

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2019-07-25
Completion
2019-07-25

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03365297 on ClinicalTrials.gov