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TherApeutics in Early ProState Cancer (TAPS02)

NCT05191680 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Apalutamide Oral Tablet [Erleada]

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

DRUG

Placebo

Placebo to match apalutamide

Sponsors & Collaborators

  • University of Cambridge

    collaborator OTHER

  • Janssen-Cilag Ltd.

    collaborator INDUSTRY

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Vincent J Gnanapragasam, Prof. · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-24
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05191680 on ClinicalTrials.gov