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

Phase 2

Recruiting

• Conditions: Oligometastatic Prostate Cancer
• Interventions: Drug: Androgen deprivation therapy (ADT); Radiation: SBRT

• Registration Number: NCT03940235
• Lead Sponsor: European Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Study Start: 2019-10-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28
• Primary Completion: 2023-12-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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;

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)	Androgen deprivation therapy (ADT)	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.
Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)	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.
Stereotactic body Radiotherapy (SBRT) only	SBRT	ARM 1: salvage SBRT for lymph nodes and/or bone metastases. All the radiologically documented lesions will be treated simultaneously.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	up 3 months from the end of the treatment up to radiological progression within 3 years	Defined as the absence of new metastatic lesions (local, regional or distant) between the two arms.

Secondary Outcome Measures

Name	Time	Method
Biochemical progression-free survival (BPFS)	up 3 months from the end of the treatment up to 3 years	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.
Numbers of patients who experienced acute and late toxicity	Up to 1 months after treatment completion and then up to 3 years	Toxicity will be assessed according to the Common Toxicity Criteria for adverse events (CTCAE) toxicity criteria v4.3
Overall survival (OS)	Up the end of SBRT until death for cancer or other causes up to 3 years	From the end of RT treatment to the time of clinical progression or mortality from specific disease cause

Trial Locations

Locations (1)

Istituto Europeo di Oncologia IRCCS; 🇮🇹 Milan, MI - Milano, Italy