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

NCT03899077 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2024-02-07

No results posted yet for this study

Summary

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.

Conditions

  • Cancer of Prostate

Interventions

DRUG

Apalutamide

Apalutamide 240mg daily for 6 months (i.e. 6 28-day cycles); oral use

DRUG

Leuprorelin Acetate 45Mg Powder for Injection Suspension Vial

Leuprorelin acetate 45mg for 6 months; subcutaneous use

DRUG

Goserelin Acetate 10.8 MG Subcutaneous Implant

Goserelin acetate 10.8mg for 6 months; subcutaneous use

DRUG

Triptorelin Pamoate

Triptorelin pamoate 22.5mg for 6 months; intramuscular use

DRUG

Degarelix acetate

Degarelix acetate 80mg for 6 months; subcutaneous use

Sponsors & Collaborators

  • Janssen Pharmaceutica

    collaborator INDUSTRY

  • Cancer Research Antwerp

    lead OTHER

Principal Investigators

  • Piet Dirix · Gasthuis Zusters Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2025-08-31
Completion
2025-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03899077 on ClinicalTrials.gov