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- Title
Radioablation +/- hormonotherapy for prostate cancer oligorecurrences (Radiosa trial): potential of imaging and biology (AIRC IG-22159).
- Authors
Marvaso, Giulia; Ciardo, Delia; Corrao, Giulia; Gandini, Sara; Fodor, Cristiana; Zerini, Dario; Rojas, Damaris Patricia; Augugliaro, Matteo; Bonizzi, Giuseppina; Pece, Salvatore; Cattani, Federica; Mazzocco, Ketti; Mistretta, Francesco Alessandro; Musi, Gennaro; Alessi, Sarah; Petralia, Giuseppe; Pravettoni, Gabriella; De Cobelli, Ottavio; Di Fiore, Pier Paolo; Viale, Giuseppe
- Abstract
<bold>Background: </bold>Prostate cancer (PCa) is the second most common cancer among men. New imaging-modalities have increased the diagnosed patients with limited number of metastasis after primary curative therapy, introducing so-called oligometastatic state. Stereotactic body radiotherapy (SBRT) is emerging as a low-toxicity treatment to erase PCa localizations and postpone androgen deprivation therapy (ADT). A deeper understanding of the predictive role of biomarkers is desirable for a targeted treatment selection and surveillance programs. The aims of the RADIOSA trial are: 1. Compare SBRT +/- ADT for oligorecurrent-castration-sensitive PCa (OCS-PCa) in terms of efficacy, toxicity and Quality of Life (QoL). 2. Develop biology/imaging based prognostic tool that allows identifying OCS-PCa subclasses.<bold>Methods: </bold>This is a randomized phase II clinical trial, recruiting 160 OCS-PCa in 3 years, with progression-free survival (PFS) as primary endpoint. Three tasks will be developed: 1. Randomized clinical study (3 years for accrual and 2 years for follow-up and data analysis); 2. Imaging study, including imaging registration and METastasis Reporting and Data System (MET-RADS) criteria; 3. Pre-clinical study, development of a biobank of blood samples for the analysis of neutrophil-to-lymphocyte ratio and preparatory for a subsequent miRNA profiling. We aim to determine which arm is justified for testing in a subsequent Phase III trial. A decision-tree algorithm, based on prognosis, biological phenotype and imaging profile, will be developed.<bold>Discussion: </bold>Recruiting will start in July 2019. SBRT will allow obtaining excellent PFS, local control, QoL and low toxicity. In SBRT arm, ADT deferral will allow for a drug-holiday, delaying the detrimental impact on QoL. A sufficient number of blood samples will be collected to perform biological patient profiling. A stratification tool will be established with an analysis of morphological and functional imaging, based on the use of MET-RADS criteria. So, in conclusion, RADIOSA aims to define the optimal management of bone/nodal PCa relapses in a SBRT regimen. This study will increase our knowledge on low-burden metastatic PCa in the era of high precision and high technology personalized medicine, offering highly effective therapy in terms of clinical outcome and cost-effectiveness.<bold>Trial Registration: </bold>The RADIOSA study was prospectively registered at clinicaltrials.gov ( NCT03940235 , May 2019).
- Subjects
CASTRATION-resistant prostate cancer; PROSTATE cancer; BIOLOGY; STEREOTACTIC radiotherapy; PROGRESSION-free survival; PATIENT selection
- Publication
BMC Cancer, 2019, Vol 19, Issue 1, pN.PAG
- ISSN
1471-2407
- Publication type
journal article
- DOI
10.1186/s12885-019-6117-z