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Therapeutics in Active Prostate Cancer Surveillance (TAPS01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03365297
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Apalutamide Phase 2

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 closer to 70,000 by 2030. A significant proportion of these men will present with organ confined and low or intermediate risk disease. There is increasing recognition that many men with low and intermediate risk prostate cancer do not need immediate radical therapy.

There is sufficient evidence that pharmacological intervention used as short-term therapy in men with low to intermediate-risk disease can inhibit the growth of prostate tumours and delay or remove the need for radical therapy in men managed by active surveillance. Given the irrefutable role of the androgen receptor in prostate cancer pathogenesis it is logical to target this pathway as a method of inhibiting or delaying disease progression.

This window study will be built on the known anti-androgen effects of apalutamide and investigate the efficacy of using it as a short intervention strategy to cause a physiological change in the tumour by reducing its volume. Tumour volume can be measured using the well-established place of mpMRI defined tumour volumes as a surrogate of disease presence and change. The rationale for a short duration treatment is that it will not have the long term debilitating effects of androgen deprivation on general health and prevent the onset of androgen resistance.

It is anticipated that if successful, this approach could be a new therapeutic strategy for these men who otherwise are living and waiting for their disease to progress or not.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single centre, single arm open labelled Phase II window study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Drug Intervention to Inhibit Cancer Progression in Men on Active Surveillance for Prostate Cancer. Therapeutics in Active Prostate Cancer Surveillance (TAPS01)
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : July 25, 2019
Actual Study Completion Date : July 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Apalutamide

Arm Intervention/treatment
Experimental: Treatment
apalutamide, 240mg (4x60mg tablets) orally, daily for a max. duration of 90 continuous days.
Drug: Apalutamide
240mg (4x60mg) oral tablets daily over a max. of 90 days
Other Names:
  • ARN509
  • JNJ-56021927




Primary Outcome Measures :
  1. Physiological Response [ Time Frame: over a 90 day treatment period ]
    Tumour volume downsizing/absence of lesion, as determined by mpMRI


Secondary Outcome Measures :
  1. Patient Reported Outcomes [ Time Frame: over 120 days ]
    Function and wellbeing using established standardised EQ-5D-5L and EORTC-QLQ30+PR25 module questionnaires

  2. Adverse Events [ Time Frame: over 120 days ]
    tolerability and side effect profile


Other Outcome Measures:
  1. Patient acceptability [ Time Frame: over an estimated 1 year recruitment period ]
    number of men approached versus recruited



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365297


Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust/Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
CCTU- Cancer Theme
Janssen-Cilag Ltd.
Investigators
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Principal Investigator: Vincent J Gnanapragasam Cambridge University Hospitals NHS Foundation Trust/University of Cambridge
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Responsible Party: CCTU- Cancer Theme, CCTU Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03365297    
Other Study ID Numbers: TAPS01
2017-001700-29 ( EudraCT Number )
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases