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

Primary Purpose

Oligometastatic Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Androgen deprivation therapy (ADT)

SBRT

About this trial

This is an interventional treatment trial for Oligometastatic Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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;

Sites / Locations

Istituto Europeo di Oncologia IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stereotactic body Radiotherapy (SBRT) only

Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Defined as the absence of new metastatic lesions (local, regional or distant) between the two arms.

Secondary Outcome Measures

Overall survival (OS)

From the end of RT treatment to the time of clinical progression or mortality from specific disease cause

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.

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

Full Information

NCT ID

NCT03940235

First Posted

April 24, 2019

Last Updated

June 27, 2023

Sponsor

European Institute of Oncology

1. Study Identification

Unique Protocol Identification Number

NCT03940235

Brief Title

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

Acronym

RADIOSA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Institute of Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oligometastatic Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stereotactic body Radiotherapy (SBRT) only

Arm Type

Experimental

Arm Description

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

Arm Title

Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Androgen deprivation therapy (ADT)

Intervention Description

SBRT + ADT

Intervention Type

Radiation

Intervention Name(s)

SBRT

Intervention Description

SBRT to all radiological documented lesions (bone or lymphnodes)

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Description

Defined as the absence of new metastatic lesions (local, regional or distant) between the two arms.

Time Frame

up 3 months from the end of the treatment up to radiological progression within 3 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

From the end of RT treatment to the time of clinical progression or mortality from specific disease cause

Time Frame

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

Title

Biochemical progression-free survival (BPFS)

Description

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.

Time Frame

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

Title

Numbers of patients who experienced acute and late toxicity

Description

Toxicity will be assessed according to the Common Toxicity Criteria for adverse events (CTCAE) toxicity criteria v4.3

Time Frame

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

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Barbara A Jereczek-Fossa, Prof

Phone

+39 0257489037

barbara.jereczek@ieo.it

First Name & Middle Initial & Last Name or Official Title & Degree

Giulia marvaso, MD

Phone

+39 0294372696

giuliamarvaso@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara A Jereczek-Fossa, Prof

Organizational Affiliation

Istituto Europeo di Oncologia IRCCS Milan, Italy

Official's Role

Study Director

Facility Information:

Facility Name

Istituto Europeo di Oncologia IRCCS

City

Milan

State/Province

MI - Milano

ZIP/Postal Code

20135

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barbara A Jereczek-Fossa, Prof

Phone

+39 0257489037

barbara.jereczek@ieo.it

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31500605

Citation

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.

Results Reference

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

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