TherApeutics in Early ProState Cancer (TAPS02)

Sponsor
Cambridge University Hospitals NHS Foundation Trust
Study ID
NCT05191680
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 24, 2023
Status verified
Oct 2024
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apalutamide 6 months
    Participants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 months.
  • Experimental: Apalutamide 3 months + Placebo 3 months
    Participants will receive apalutamide 240mg (4 x 60 mg tablets) orally once a day for up to 3 months followed by placebo to match apalutamide (4 tablets) orally once a day for up to 3 months.
  • Placebo Comparator: Placebo 6 months
    Participants will receive placebo to match apalutamide (4 tablets) orally once a day for up to 6 months.

Primary Outcome Measure

MRI defined tumour volume [ Time Frame: 12 months after end of treatment ]

Central Contacts

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