Status:
COMPLETED
Therapeutics in Active Prostate Cancer Surveillance
Lead Sponsor:
CCTU- Cancer Theme
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 Survei...
Detailed Description
The numbers of men diagnosed with prostate cancer in the United Kingdom (UK) and worldwide is increasing. In the UK 46,690 men were diagnosed in 2014 alone and it is estimated this figure will be clos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03365297
Start Date
June 5 2018
End Date
July 25 2019
Last Update
November 19 2019
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust/Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ