Cancer
Cancer Ongoing 2021 NSW, QLD, WA

PRIMORDIUM

The hypothesis of study is addition of apalutamide to RT+ LHRHa provides superior efficacy in terms of PSMA-PET metastatic progression-free survival-ppMPFS.

Trial overview

Disease
Prostate cancer
Topic
PRIMORDIUM
Description
A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapyand LHRH Agonist in High-Risk Patients with PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, with an Observational Follow-up of PSMA-PET-Negative Patients.
Eligibility criteria
  • Histologically confirmed adenocarcinoma of the prostate 
  • Previously treated with radical prostatectomy with lymph node dissection and first post-operative PSA measurement of <0.1ng/mL between Week6 and Week13
  • Biochemically recurrent prostate cancer after Radical Prostatectomy with a high risk of developing metastasis
Study details

Participants will be randomized (1:1 ratio) to receive either RT+LHRHa or RT+LHRHa plus apalutamideasthe study interventions. For this study, radiotherapy is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (with or without optional SBRT for participants with ≤3 metastases). 

Further information

For more information regarding this clinical trial click here.

Location

NSW, QLD, WA