- 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
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
Minimum age: 18
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
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
Publications
Websites
N/A
NCT05717660
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