APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer

  • Unknown
  • Treatment
  • Interventional
  • Randomized
  • Combination Product
  • PHASE2
  • Azienda Ospedaliero-Universitaria Careggi
  • 18 Years -


Study Purpose

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.

Intervention

Combination Product : SBRT on all sites of metastatic disease+Apalutamide


Eligibility Requirements

info icon Patients who have signed written informed consent

info icon Adult patients ≥ 18 years

info icon Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions \*, \*\*

info icon All lesions must be amenable to SBRT in judgment of treating radiation oncologist \*\*\*

info icon Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered

info icon Androgen deprivation therapy (ADT) started ≤ 6 months before enrollment

info icon Patients should be eligible to Apalutamide treatment

info icon Minimum age: 18

info icon Presence of visceral disease

info icon De novo metastatic disease

info icon Any contraindication to the use of Apalutamide

info icon Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated

Recruiting status

Unknown

Estimated enrollment

180

 
Study start date

Mar 11, 2023

Study end date

Mar 11, 2025

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Combination Product

Study phase

PHASE2

Allocation

Randomized

 

Sponsor:

Azienda Ospedaliero-Universitaria Careggi

Collaborator:

N/A

Investigator:

N/A

NCT05717660

Clinic Location Investigator Distance RECRUITING STATUS Contact