PRIMORDIUM

Prostate cancer

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.

To be considered for the study you must meet the following criteria:

• Aged 18+ Male
• Histologically confirmed adenocarcinoma of the prostate
• Previously treated with radical prostatectomy with or without lymph node dissection and any post-operative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/millilitre (ng/mL) between Week 6 and Week 20
• PSMA-PET-positive for at least one loco-regional (pelvic) lesion with or without distant (extra-pelvic) will be eligible to be randomized to either arm of the Interventional Cohort. PSMA-PET-negative for any prostate cancer lesions (that is no loco-regional lesion and no distant lesion) will be eligible for inclusion in the Observational Cohort
• Biochemically recurrent prostate cancer after RP with a high risk of developing metastasis defined as pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, OR PSADT less than or equal to (<=) 12 months at the time of screening
• No evidence of prostate cancer metastases
• Eastern Cooperative Oncology Group Performance Status Grade 0 or 1

Apalutamide is a non-steroidal androgen receptor (AR) antagonist being developed for the treatment of prostate cancer. This study aims to determine if addition of apalutamide to RT+ LHRHa improves PSMA-PET metastatic progression-free survival. Patients with PSMA-PET positive hormone sensitive prostate cancer will be randomised to receive apalutamide+RT+LHRHa or  RT+LHRHa alone.

Patient who are screened but are negative on PSMA-PET will be offered participation in an observational cohort.

For more information regarding this clinical trial click here.