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

Radioablation +/- Hormonotherapy for Prostate Cancer Oligorecurrences (RADIOSA Trial): Potential of Imaging and Biology

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 Overview

• Status: Recruiting
• Conditions: Oligometastatic Prostate Cancer
• Intervention / Treatment: Radiation: SBRT; Drug: Androgen deprivation therapy (ADT)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Barbara A Jereczek-Fossa, Prof; Phone Number: +39 0257489037; Email: barbara.jereczek@ieo.it
• Study Contact Backup: Name: Giulia marvaso, MD; Phone Number: +39 0294372696; Email: giuliamarvaso@gmail.com

Study Locations

• Italy
  • MI - Milano
    • Milan, MI - Milano, Italy, 20135
      • Recruiting
      • Istituto Europeo di Oncologia IRCCS
      • Contact: Barbara A Jereczek-Fossa, Prof; Phone Number: +39 0257489037; Email: barbara.jereczek@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic body Radiotherapy (SBRT) only; ARM 1: salvage SBRT for lymph nodes and/or bone metastases. All the radiologically documented lesions will be treated simultaneously.	Radiation: SBRT; SBRT to all radiological documented lesions (bone or lymphnodes)
Active Comparator: Stereotactic body Radiotherapy (SBRT) and hormonotherapy (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.	Radiation: SBRT; SBRT to all radiological documented lesions (bone or lymphnodes); Drug: Androgen deprivation therapy (ADT); SBRT + ADT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	From the end of RT treatment to the time of clinical progression or mortality from specific disease cause	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.	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	Up to 1 months after treatment completion and then up to 3 years

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Study Director: Barbara A Jereczek-Fossa, Prof, Istituto Europeo di Oncologia IRCCS Milan, Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: IEO 997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No