TY - JOUR
T1 - Radioablation +/- hormonotherapy for prostate cancer oligorecurrences (Radiosa trial)
T2 - Potential of imaging and biology (AIRC IG-22159)
AU - Marvaso, Giulia
AU - Ciardo, Delia
AU - Corrao, Giulia
AU - Gandini, Sara
AU - Fodor, Cristiana
AU - Zerini, Dario
AU - Rojas, Damaris Patricia
AU - Augugliaro, Matteo
AU - Bonizzi, Giuseppina
AU - Pece, Salvatore
AU - Cattani, Federica
AU - Mazzocco, Ketti
AU - Mistretta, Francesco Alessandro
AU - Musi, Gennaro
AU - Alessi, Sarah
AU - Petralia, Giuseppe
AU - Pravettoni, Gabriella
AU - De Cobelli, Ottavio
AU - Di Fiore, Pier Paolo
AU - Viale, Giuseppe
AU - Orecchia, Roberto
AU - Jereczek-Fossa, Barbara Alicja
PY - 2019/9/10
Y1 - 2019/9/10
N2 - Background: 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. Methods: 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. Discussion: 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. Trial registration: The RADIOSA study was prospectively registered at clinicaltrials.gov (NCT03940235, May 2019).
AB - Background: 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. Methods: 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. Discussion: 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. Trial registration: The RADIOSA study was prospectively registered at clinicaltrials.gov (NCT03940235, May 2019).
KW - Androgen deprivation therapy
KW - Oligometastasis
KW - Prostate cancer
KW - Radiotherapy
KW - Stereotatic body radiation therapy
UR - http://www.scopus.com/inward/record.url?scp=85071976156&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071976156&partnerID=8YFLogxK
U2 - 10.1186/s12885-019-6117-z
DO - 10.1186/s12885-019-6117-z
M3 - Article
C2 - 31500605
AN - SCOPUS:85071976156
VL - 19
JO - BMC Cancer
JF - BMC Cancer
SN - 1471-2407
IS - 1
M1 - 903
ER -