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

European Institute of Oncology

Status and phase: Enrolling; Phase 2

Conditions: Oligometastatic Prostate Cancer

Treatments: Radiation: SBRT; Drug: Androgen deprivation therapy (ADT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03940235

IEO 997

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Stereotactic body Radiotherapy (SBRT) only

Experimental group

Description:

ARM 1: salvage SBRT for lymph nodes and/or bone metastases. All the radiologically documented lesions will be treated simultaneously.

Treatment:

Radiation: SBRT

Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)

Active Comparator group

Description:

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.

Treatment:

Radiation: SBRT

Drug: Androgen deprivation therapy (ADT)