A Phase 2 interventional study of Androgen deprivation therapy (ADT) and SBRT in Oligometastatic Prostate Cancer, sponsored by European Institute of Oncology. Recruiting at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by European Institute of Oncology · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 150 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →European Institute of Oncology is the lead sponsor of 178 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
ARM 1: salvage SBRT for lymph nodes and/or bone metastases. All the radiologically documented lesions will be treated simultaneously.
Radiation: SBRT
ARM 2: salvage SBRT (as described for ARM 1) + 6-month ADT (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist). ADT should start within one week before the start of SBRT.
Drug: Androgen deprivation therapy (ADT) · Radiation: SBRT
SBRT + ADT
SBRT to all radiological documented lesions (bone or lymphnodes)
Progression-free survival (PFS)
Defined as the absence of new metastatic lesions (local, regional or distant) between the two arms.
Time frame: up 3 months from the end of the treatment up to radiological progression within 3 years
Overall survival (OS)
From the end of RT treatment to the time of clinical progression or mortality from specific disease cause
Time frame: Up the end of SBRT until death for cancer or other causes up to 3 years
Biochemical progression-free survival (BPFS)
Biochemical progression is defined according to the EAU guidelines \[18\], namely a rising PSA level \>0.2 ng/ml following radical prostatectomy and \>2 ng/ml above the nadir after radiation therapy.
Time frame: up 3 months from the end of the treatment up to 3 years
Numbers of patients who experienced acute and late toxicity
Toxicity will be assessed according to the Common Toxicity Criteria for adverse events (CTCAE) toxicity criteria v4.3
Time frame: Up to 1 months after treatment completion and then up to 3 years
Plan to share: No
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European Institute of Oncology