Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy

Sponsor
UNICANCER
Study ID
NCT04181203
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    240 mg PO daily should start the same day as the first LHRHa administration for 6 months. months.
  • Salvage radiotherapy (SRT) — RADIATION
    The SRT treatment will be administered to a total dose of 66 Gy (in 33 fractions of 2 Gy) directed at the prostate bed with an additional 56.1 Gy (in 33 fractions of 1.7 Gy) directed at the pelvis region. The pelvis will be irradiated in all patients. An additional simultaneously integrated boost of 69.3 Gy (in 33 fractions of 2.1 Gy) can be delivered to a local relapse based on Positron Emission Tomography - Computed Tomography (PET/CT) and Magnetic Resonance Imaging (MRI) images.
  • Luteinising Hormone Releasing Hormone agonist (LHRHa) — DRUG
    Doses of LHRHa may vary due to availability of different brand names and pharmaceutical forms. It will be left to the discretion of the investigator.

Study Details

This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.

Key Dates

Start date
Jan 9, 2020
Status verified
Jun 2025
Primary completion
Sep 28, 2028
Completion
Dec 28, 2033

Study Design

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

Arms

  • Active Comparator: SRT + 6 months of LHRHa
    * Treatment with LHRHa will start 4 weeks before the first RT fraction (i.e Day 1 of Week 1 of treatment period.) The total duration of the LHRHa treatment is 6 months. * SRT will start 4 weeks after the first administration of LHRHa (i.e Day 1 of Week 5 of treatment period.). The total duration of SRT is 6.5 weeks.
  • Experimental: SRT + 6 months of LHRHa + 6 months of Apalutamide
    * Treatment with LHRHa will start 4 weeks before the first RT fraction (i.e Day 1 of Week 1 of treatment period.) The total duration of the LHRHa treatment is 6 months. * Treatment with apalutamide (240 mg PO daily) should start the same day as the first LHRHa administration, for 6 months. * SRT will start 4 weeks after the first administration of LHRHa (i.e Day 1 of Week 5 of treatment period.). The total duration of SRT is 6.5 weeks.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 5 years ]

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