APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer (PERSIAN)

Azienda Ospedaliero-Universitaria Careggi

Status and phase

Not yet enrolling

Phase 2

Conditions

Oligometastatic Hormone Sensitive Prostate Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05717660

PERSIAN

Details and patient eligibility

About

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.

Full description

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.

Enrollment

180 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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