APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer

Conditions

• Oligometastatic Hormone Sensitive Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SBRT on all sites of metastatic disease+Apalutamide — COMBINATION_PRODUCT
  oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of 10.

Study Details

Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.

Key Dates

Start date

Mar 11, 2023

Status verified

Jan 2023

Primary completion

Sep 11, 2024

Completion

Mar 11, 2025

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Control
  Androgen Deprivation therapy and Apalutamide
• Experimental: Treatment
  Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease

Primary Outcome Measure

Complete biochemical response [ Time Frame: 6 months after treatment start. ]