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TherApeutics in Early ProState Cancer (TAPS02)

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorCambridge University Hospitals NHS Foundation Trust

About this trial

This is a phase 2, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have given written informed consent to participate.

Be aged 18 or over.

Have an Eastern Cooperative Oncology Group (ECOG) status 0-2.

Have selected active surveillance as a management option.

Disqualifiers

Contraindications to apalutamide or its excipients.

Pelvic metalwork interfering with MRI prostate interpretation.

Any prior or concurrent use of androgen deprivation therapy (ADT) or androgen receptor targeting agents (not including established and continued use of 5-ARIs for urinary symptoms).

Systemic therapy for prostate cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apalutamide Oral Tablet [Erleada]

    Drug

    Apalutamide is a selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.

  • Placebo

    Drug

    Placebo to match apalutamide

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Apalutamide 6 monthsExperimental treatment 1 intervention
Group B: Apalutamide 3 months + Placebo 3 monthsExperimental treatment 2 interventions
Group C: Placebo 6 monthsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

MRI defined tumour volume

To determine whether there is a reduction in MRI defined tumour volume at 12 months post treatment in at least 50% of the treated cohort in either treatment arm compared to the baseline measurement.

Time frame
12 months after end of treatment

Secondary outcomes

1

Reported adverse events

As per NCI-CTCAE v5.0

Time frame
Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)
2

Patient-reported outcomes EORTC QLQ-C30

Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQ-C30).

Time frame
Cumulative until 12 months after end of treatment
3

Patient-reported outcomes EQ-5D-5L

Assessed using the EQ-5D-5L questionnaire developed by the EuroQol Group.

Time frame
Cumulative until 12 months after end of treatment
4

Cumulative rate of progression (any progression)

the overall rate of disease progression

Time frame
3 years after completion of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cambridge University Hospitals NHS Foundation Trust

Lead sponsor

University of Cambridge

Collaborator

Janssen-Cilag Ltd.

Collaborator

Source ClinicalTrials.gov
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