A study of the use of apalutamide (ARN509) to reduce tumour volumes in men on active surveillance for prostate cancer
- Conditions
- Prostate cancer, managed by active surveillance - low or intermediate risk according to NICE classification and an MRI score of = 3 for lesion probability using PIRAD version 2 reporting criteria.MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001700-29-GB
- Lead Sponsor
- Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
-Given Informed Consent (IC) to participate
-Age 18 or over
-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
-Willing to use two high effective forms of contraception throughout their participation in the trial and for three months after their last dose
-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 of intermediate risk according to NICE classification
-MRI score of = 3 using PIRAD version 2 reporting criteria
- Adequate haematological, renal and liver organ function (measured within 14 days prior to planned first trial drug administration)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
-Contraindication to apalutamide or its excipients
-Concurrent medication that can lower seizure threshold
- Clinically significant change in tumour volume as assessed by mpMRI at the baseline in comparison with the previous standard of care mpMRI prior to enrolment into the trial
-Prior localised or systemic therapy for prostate cancer
-Prior use of androgen deprivation therapy or androgen receptor targeting agents
-Prior systemic therapy for prostate cancer
-Patient unable to have prostate 3T mpMRI scan
-Presence of any pelvic or hip metalwork
- Conditions resulting in the inability to swallow or absorb the trial drug or contrast agents
- Poor medical risk due to uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection, or as judged by the investigator.
- Patient unsuitable to participate as unlikely to comply with trial procedures, as judged by the investigator
- Patient with previous non-related malignancy that have undergone treatment with curative intent or who are ongoing treatment
- Participation in any other clinical trials involving an IMP or interventional delivery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to test if short-term use of apalutamide can reduce image defined tumour volumes in men with prostate cancer and a detectable lesion on multi-parametric MRI (mpMRI) who are being managed by Active Surveillance (AS).;Secondary Objective: The secondary objective of this study is to evaluate the tolerability and side effect profile of men on AS using short-term apalutamide as a therapeutic strategy.;Primary end point(s): Physiological response defined as achieving tumour downsizing as determined by mpMRI or absence of a lesion, 90 days from the start of treatment with the trial drug. mpMRI will include standard T2 weighted imaging, diffusion weighted imaging and dynamic contrast enhancement. The use of mpMRI as a surrogate marker of treatment response in window trials has been reported from our institute. ;Timepoint(s) of evaluation of this end point: Baseline and on day 90 of IMP administration
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Tolerability and side effects assessed using patient-reported outcomes measuring urinary and sexual function as well as overall wellbeing using established and standardised questionnaires: (i) European Organisation for research and Treatment of Cancer (EORTC)-QLQ 30 + prostate specific module (PR 25) and (ii) the EuroQol (EQ-5D-5L) questionnaire.<br><br> Adverse events (according to NCI-CTCAE v4.03)<br><br> Exploratory outcome measure:<br> Patient acceptability measured as percentage of patients recruited from patients consented or approached; reasons for declined participation; reasons for withdrawal.<br><br> ;Timepoint(s) of evaluation of this end point: All secondary & exploratory endpoints will be assessed at all visits during the clinical trial.