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

Oligometastatic Prostate Cancer Clinical Trial

— RADIOSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940235
• Other study ID #: IEO 997
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2023
• Source: European Institute of Oncology
• Contact: Barbara A Jereczek-Fossa, Prof
• Phone: +39 0257489037
• Email: barbara.jereczek[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Oligometastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Androgen deprivation therapy (ADT)
SBRT + ADT

Radiation:
• SBRT
SBRT to all radiological documented lesions (bone or lymphnodes)

Locations

Country	Name	City	State
Italy	Istituto Europeo di Oncologia IRCCS	Milan	MI - Milano

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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