Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP

Sponsor
Cancer Research Antwerp
Study ID
NCT03899077
Phase
PHASE2
Status
Unknown

Conditions

  • Cancer of Prostate

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    Apalutamide 240mg daily for 6 months (i.e. 6 28-day cycles); oral use
  • Leuprorelin Acetate 45Mg Powder for Injection Suspension Vial — DRUG
    Leuprorelin acetate 45mg for 6 months; subcutaneous use
  • Goserelin Acetate 10.8 MG Subcutaneous Implant — DRUG
    Goserelin acetate 10.8mg for 6 months; subcutaneous use
  • Triptorelin Pamoate — DRUG
    Triptorelin pamoate 22.5mg for 6 months; intramuscular use
  • Degarelix acetate — DRUG
    Degarelix acetate 80mg for 6 months; subcutaneous use

Study Details

This is a phase II randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist (arm A) versus anti-androgen therapy (AAT) with apalutamide 240mg daily (arm B) in hormone-naïve patients with biochemical progression after radical prostatectomy. All subjects will receive salvage radiotherapy as standard of care and will be randomly assigned in a 1:1 ratio to receive either 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist through 6 monthly, two 3-monthly or one 6-monthly injections (control arm) or 6 28-day cycles of apalutamide 240mg daily (interventional arm). The study will include a screening phase, treatment phase, and a post-treatment phase. The primary objective of the trial is to compare sexual function between the 2 groups based on the Expanded Prostate cancer Index Composite (EPIC)-26 sexual domain scores at 9 months after start of hormonal treatment.

Key Dates

Start date
Apr 5, 2019
Status verified
Feb 2024
Primary completion
Aug 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Active Comparator: Arm A
    The standard hormonal treatment in combination with salvage radiotherapy is ADT by a LHRH agonist or antagonist for 24 weeks. LHRH agonists and antagonists include leuprolide, goserelin, triptorelin, and degarelix.
  • Experimental: Arm B
    Patients will receive 6 cycles (each cycle is 30 days) of the study drug (4x 60mg tablets daily in a single intake).

Primary Outcome Measure

EPIC-26 sexual domain score [ Time Frame: 9 months after start of hormonal treatment ]

Central Contacts

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