Radioablation With or Without Androgen DeprIvation Therapy in Metachronous Prostate Cancer OligometaStAsis

European Institute of Oncology150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Oligometastatic Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

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

Secondary Outcomes

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