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TherApeutics in Early ProState Cancer (TAPS02)

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Phase: Phase 3 to Phase 2v6 Show 5 more changesShow less
    • Enrollment target: 402 to 90
    • Primary and study completion dates: Apr 2031 to Oct 2029
    • Primary endpoints: 2 to 1
    • Study sites: 4 to 6
    • Secondary endpoints: 8 to 5
  2. Study sites: 1 to 4v5
  3. Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (8)
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Oct 2022 to Apr 24, 2023
    • Study sites: 0 to 1
    • Primary and study completion dates: Oct 2030 to Apr 2031
    • Study title shortened, about 1 word
  5. Start date: Jul 2022 to Oct 2022v2 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 335 to 402
    • Primary and study completion dates: Jul 2030 to Oct 2030
    • Eligibility criteria expanded, about 145 words
    • Secondary endpoints: 7 to 8
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05191680
Lead Sponsor Cambridge University Hospitals NHS Foundation Trust
Collaborators: University of Cambridge, Janssen-Cilag Ltd.
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov