START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC — START-MET  

Prostate Cancer Clinical Trial

Official title: Phase III Study of Stereotactic Body Radiation Therapy (SBRT) Plus Standard of Care in Castration Sensitive Oligometastatic Prostate Cancer Patients.

Status Recruiting

Clinical Trial Summary

Phase III study of stereotactic body radiation therapy (SBRT) plus standard of care in castration sensitive oligometastatic prostate cancer patients, defined as androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients and second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) vs androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients plus second generation hormonal treatments, for the treatment of oligometastatic prostate cancer.

Clinical Trial Description

A total of 266 patients with a histological diagnosis of metastatic hormone sensitive prostate cancer, with limited disease (≤ 3 lesions based on CT and Bone Scan and ≤ 5 lesions based on Choline or PSMA PET/TC) at the diagnosis or in an oligorrecurrent stage will be included in the study. Candidates will be first screened for metastatic sites through bone scintigraphy and computerised tomography (CT) scans. Those who meet the ≤3 metastatic sites criteria will be second screened for metastatic sites based on Choline or PSMA PET/TC, which will be used to define the treatment volume of metastatic disease with SBRT/HIGRT and to confirm the oligometastatic status before the inclusion in the study.

Once included in the study, patients will be randomize (1:1) to standard of care + SBRT vs standard of care.

• Interventional arm: STANDARD OF CARE + SBRT (all metastatic lesions). ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment

• Control arm: STANDARD OF CARE. ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment

Patients will be stratified according to prior local treatment (yes/no) or the new imaging technique used (Choline vs PSMA PET/TC). ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Stereotactic Body Radiation Therapy

• NCT number: NCT05209243
• Study type: Interventional
• Source: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
• Contact: Antonio J Conde Moreno, MD PhD
• Phone: +34 649039866
• Email: antoniojconde@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2023
• Completion date: January 2027