APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer

NCT ID: NCT05717660

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-11
• Study Completion Date: 2025-03-11

Brief Summary

Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.

Detailed Description

Prospective Phase II randomized superiority study, open label, multicentric. Patients with Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions and treated with androgen deprivation treatment associated with Apalutamide will be randomized to receive standard systemic treatment alone or concomitant SBRT on all sites of metastatic disease.

Conditions

Oligometastatic Hormone Sensitive Prostate Cancer

Study Design

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

Study Groups

Control

Androgen Deprivation therapy and Apalutamide

Group Type: ACTIVE_COMPARATOR

SBRT on all sites of metastatic disease+Apalutamide

Intervention Type: COMBINATION_PRODUCT

oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of 10.

Treatment

Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease

Group Type: EXPERIMENTAL

SBRT on all sites of metastatic disease+Apalutamide

Intervention Type: COMBINATION_PRODUCT

oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of 10.

Interventions

SBRT on all sites of metastatic disease+Apalutamide

oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of 10.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Patients who have signed written informed consent
• Adult patients ≥ 18 years
• Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions *, **
• All lesions must be amenable to SBRT in judgment of treating radiation oncologist ***
• Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered
• Androgen deprivation therapy (ADT) started ≤ 6 months before enrollment
• Patients should be eligible to Apalutamide treatment

Exclusion Criteria

• Presence of visceral disease
• De novo metastatic disease
• Any contraindication to the use of Apalutamide
• Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated

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

Sponsors

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Livi

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Careggi Radiation Oncology Unit

Florence, , Italy

Countries

Italy

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Other Identifiers

PERSIAN

Identifier Type: -

Identifier Source: org_study_id