Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT03488810
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy — OTHER
    Dose escalated Intensity-Modulated Radiation therapy (IMRT) with conventional fractionation, hypofractionation and prostate brachytherapy are allowed.
  • Apalutamide — DRUG
    240 mg PO daily, started the same day as the first LHRHa injection, for 6 months
  • Luteinising Hormone Releasing Hormone analog agonist (LHRHa) — DRUG
    2 injections of a three-monthly LHRH agonist depot
  • Non-steroidal anti-androgen — DRUG
    Non-steroidal anti-androgen (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection

Study Details

The main objective of the trial to determine if the combination of apalutamide with 6 months of androgen deprivation therapy by LHRH agonists in patients with intermediate and limited high-risk, localized prostate cancer receiving primary radiation therapy (RT) results in an improvement of disease-free survival (DFS) evaluated by the treating physician, in comparison to the combination of radiation and androgen deprivation therapy without the addition of apalutamide.

Key Dates

Start date
Mar 10, 2020
Status verified
Aug 2020
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: ADT + radiation therapy
    Patient will receive 2 injections of a three-monthly LHRH agonist depot plus non-steroidal anti-androgen (rescue treatment) (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection. All patients will receive standard fractionation radiation therapy (RT) between 0 and 12 weeks after first injection of LHRH agonist.
  • Experimental: Arm B: ADT + radiation therapy + Apalutamide
    Patients will receive 2 injections of a three-monthly LHRH agonist depot. Apalutamide treatment: 240 mg PO daily, started the same day as the first LHRHa injection, for 6 months. All patients will receive standard fractionation radiation therapy (RT) between 0 and 12 weeks after first injection of LHRH agonist.

Primary Outcome Measure

Disease-free survival [ Time Frame: 7.8 years from First Patient In (FPI) ]

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