Clinical trial NCT03940235: Radioablation With or Without Androgen DeprIvation Therapy in Metachronous Prostate Cancer OligometaStAsis
Official title: Radioablation +/- Hormonotherapy for Prostate Cancer Oligorecurrences (RADIOSA Trial): Potential of Imaging and Biology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oligometastatic Prostate Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized phase II clinical trial (RADIOSA trial: Radioablation with or without Androgen DeprIvation therapy in metachronous prostate cancer OligometaStAsis).

The aim is to compare time to progression between the two study arms: SBRT only or SBRT and hormonotherapy (ADT). The primary objective is to compare the progression-free survival (PFS) defined as the absence of new metastatic lesions (local, regional or distant) between the two arms. The secondary endpoints include the comparison of overall survival (OS), biochemical progression-free survival (BPFS), ADT-free survival, local control, treatment-induced acute and late toxicity, time to castration-resistant disease and QoL between the two arms; the development of a dedicated biobanking (collection of plasma and serum) for further biological investigation of predictive/diagnostic factors for personalized treatment; the preliminary evaluation of prognostic biomarkers; the correlation between imaging-derived parameters and treatment outcome.


Eligibility criteria: Inclusion Criteria:

* Histologically proven initial diagnosis of adenocarcinoma of the prostate;
* Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/salvage radiotherapy) +/- ADT according to the European Association of Urology (EAU) guidelines 2016 \[18\] or after any salvage therapy if biochemical progression is diagnosed in the context of castration sensitive PCa;
* Nodal relapse in the pelvis, extra-regional nodal relapse (M1a), bone metastases (M1b) on Ch-PET/CT or WBMRI with a maximum of 3 lesions;
* Serum testosterone level \>50 ng/dl at the time of randomization (castration sensitive PCa)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* Age ≥18 years;
* Written informed consent signed

Exclusion criteria

* Serious concomitant comorbidities or contraindication to SBRT and/or ADT;
* Previous invasive cancer (within 3 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies;
* No ability to complete questionnaires about QoL;
* Presence of mental diseases that cannot ensure valid informed consent;

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up 3 months from the end of the treatment up to radiological progression within 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up the end of SBRT until death for cancer or other causes up to 3 years
measure: Biochemical progression-free survival (BPFS)
timeFrame: up 3 months from the end of the treatment up to 3 years
measure: Numbers of patients who experienced acute and late toxicity
timeFrame: Up to 1 months after treatment completion and then up to 3 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
state: MI - Milano
Study officials:
affiliation: Istituto Europeo di Oncologia IRCCS Milan, Italy
name: Barbara A Jereczek-Fossa, Prof
role: STUDY_DIRECTOR
References:
citation: Marvaso G, Ciardo D, Corrao G, Gandini S, Fodor C, Zerini D, Rojas DP, Augugliaro M, Bonizzi G, Pece S, Cattani F, Mazzocco K, Mistretta FA, Musi G, Alessi S, Petralia G, Pravettoni G, De Cobelli O, Di Fiore PP, Viale G, Orecchia R, Jereczek-Fossa BA. Radioablation +/- hormonotherapy for prostate cancer oligorecurrences (Radiosa trial): potential of imaging and biology (AIRC IG-22159). BMC Cancer. 2019 Sep 10;19(1):903. doi: 10.1186/s12885-019-6117-z.