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

NCT ID: NCT03940235

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2024-04-01

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.

Conditions

Oligometastatic Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

SBRT to all radiological documented lesions (bone or lymphnodes)

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.

Group Type: ACTIVE_COMPARATOR

Androgen deprivation therapy (ADT)

Intervention Type: DRUG

SBRT + ADT

SBRT

Intervention Type: RADIATION

SBRT to all radiological documented lesions (bone or lymphnodes)

Interventions

Androgen deprivation therapy (ADT)

SBRT + ADT

Intervention Type: DRUG

SBRT

SBRT to all radiological documented lesions (bone or lymphnodes)

Intervention Type: RADIATION

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara A Jereczek-Fossa, Prof

Role: STUDY_DIRECTOR

Istituto Europeo di Oncologia IRCCS Milan, Italy

Locations

Istituto Europeo di Oncologia IRCCS

Milan, MI - Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Barbara A Jereczek-Fossa, Prof

Role: CONTACT

barbara.jereczek@ieo.it

+39 0257489037

Giulia marvaso, MD

Role: CONTACT

giuliamarvaso@gmail.com

+39 0294372696

Facility Contacts

Barbara A Jereczek-Fossa, Prof

Role: primary

barbara.jereczek@ieo.it

+39 0257489037

References

Vavassori A, Mauri G, Mazzola GC, Mastroleo F, Bonomo G, Durante S, Zerini D, Marvaso G, Corrao G, Ferrari ED, Rondi E, Vigorito S, Cattani F, Orsi F, Jereczek-Fossa BA. Cyberknife Radiosurgery for Prostate Cancer after Abdominoperineal Resection (CYRANO): The Combined Computer Tomography and Electromagnetic Navigation Guided Transperineal Fiducial Markers Implantation Technique. Curr Oncol. 2023 Aug 28;30(9):7926-7935. doi: 10.3390/curroncol30090576.

Reference Type: DERIVED

PMID: 37754491 (View on PubMed)

Carloni G, Garibaldi C, Marvaso G, Volpe S, Zaffaroni M, Pepa M, Isaksson LJ, Colombo F, Durante S, Lo Presti G, Raimondi S, Spaggiari L, de Marinis F, Piperno G, Vigorito S, Gandini S, Cremonesi M, Positano V, Jereczek-Fossa BA. Brain metastases from NSCLC treated with stereotactic radiotherapy: prediction mismatch between two different radiomic platforms. Radiother Oncol. 2023 Jan;178:109424. doi: 10.1016/j.radonc.2022.11.013. Epub 2022 Nov 24.

Reference Type: DERIVED

PMID: 36435336 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31500605 (View on PubMed)

Other Identifiers

IEO 997

Identifier Type: -

Identifier Source: org_study_id