APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer

Azienda Ospedaliero-Universitaria Careggi180 enrolled

Overview

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.

Prospective Phase II randomized superiority study, open label, multicentric. Patients with Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions and treated with androgen deprivation treatment associated with Apalutamide will be randomized to receive standard systemic treatment alone or concomitant SBRT on all sites of metastatic disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Oligometastatic Hormone Sensitive Prostate Cancer

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who have signed written informed consent * Adult patients ≥ 18 years * Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions \*, \*\* * All lesions must be amenable to SBRT in judgment of treating radiation oncologist \*\*\* * 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 * Androgen deprivation therapy (ADT) started ≤ 6 months before enrollment * Patients should be eligible to Apalutamide treatment Exclusion Criteria: * Presence of visceral disease * De novo metastatic disease * Any contraindication to the use of Apalutamide * Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated

Outcomes

Primary Outcomes

Complete biochemical response

Rate of patients with complete biochemical response (PSA \< 0.2 ng/ml)

Time frame: 6 months after treatment start.