Therapeutics in Active Prostate Cancer Surveillance

• Status: Completed
• Trial end date: 2019-07-25
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CCTU- Cancer Theme
• Collaborator: Janssen-Cilag Ltd.

Criteria

Inclusion Criteria:

• Given Informed Consent (IC) to participate

• Age 18 or over

• Eastern Cooperative Oncology Group (ECOG) status 0-2

• Diagnosed with prostate cancer

• Patient selection of active surveillance as a management option

• mpMRI detectable lesion

• Prostate cancer on biopsy from a mpMRI defined lesion

• No contraindications to apalutamide

• Normal full blood count and normal renal and liver function tests

• At least 6 months since initiation of active surveillance and/or last rebiopsy date.

• Low or intermediate risk prostate cancer according to National Institute for Health and Care Excellence (NICE) classification

• M score of ≥ 3 using Prostate Imaging Reporting and Data System (PIRADS) version 2 reporting criteria

Exclusion Criteria:

• Contraindications to apalutamide or its excipients

• Concurrent medication that can lower seizure threshold

• Prior localised therapy for prostate cancer

• Any prior use of androgen deprivation therapy or androgen receptor targeting agents

• Any prior systemic therapy for prostate cancer

• Patient unable to have prostate 3T mpMRI scan

• Presence of any pelvic or hip metalwork