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

NCT03940235 | Unknown Phase 2

• 1 other identifier: IEO 997
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival (OS)

  Up the end of SBRT until death for cancer or other causes up to 3 years

• Biochemical progression-free survival (BPFS)

  up 3 months from the end of the treatment up to 3 years

• Numbers of patients who experienced acute and late toxicity

  Up to 1 months after treatment completion and then up to 3 years

Study Arms (2)

Stereotactic body Radiotherapy (SBRT) only

EXPERIMENTAL

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

Radiation: SBRT

Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)

ACTIVE COMPARATOR

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.

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

Interventions

Androgen deprivation therapy (ADT) DRUG

SBRT + ADT

Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)

SBRT RADIATION

SBRT to all radiological documented lesions (bone or lymphnodes)

Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT); Stereotactic body Radiotherapy (SBRT) only

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Istituto Europeo di Oncologia IRCCS

Milan, MI - Milano, 20135, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 37754491 DERIVED

• 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.

  PMID: 36435336 DERIVED

• 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.

  PMID: 31500605 DERIVED

MeSH Terms

Interventions

Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Barbara A Jereczek-Fossa, Prof

  Istituto Europeo di Oncologia IRCCS Milan, Italy

  STUDY DIRECTOR

Central Study Contacts

Barbara A Jereczek-Fossa, Prof

CONTACT

+39 0257489037; barbara.jereczek@ieo.it

Giulia marvaso, MD

CONTACT

+39 0294372696; giuliamarvaso@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 7, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)