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
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
Treatments tested in this trial
- Apalutamide Oral Tablet [Erleada]
- Placebo
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Cambridge University Hospitals NHS Foundation Trust
Lead sponsor
University of Cambridge
Collaborator
Janssen-Cilag Ltd.
Collaborator
Source ClinicalTrials.gov