Therapeutics in Active Prostate Cancer Surveillance

NCT03365297 | Completed Phase 2

• 2 other identifiers: TAPS012017-001700-29
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Physiological Response

  Tumour volume downsizing/absence of lesion, as determined by mpMRI

  over a 90 day treatment period

Secondary Outcomes (2)

• Patient Reported Outcomes

  over 120 days

• Adverse Events

  over 120 days

Other Outcomes (1)

• Patient acceptability

  over an estimated 1 year recruitment period

Study Arms (1)

Treatment

EXPERIMENTAL

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

Drug: Apalutamide

Interventions

Apalutamide DRUG

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

Also known as: ARN509, JNJ-56021927

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust/Addenbrookes Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Vincent J Gnanapragasam

  Cambridge University Hospitals NHS Foundation Trust/University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CCTU Cancer Theme

Model Details: Single centre, single arm open labelled Phase II window study

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 7, 2017
• Study Start: June 5, 2018
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: November 19, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)