NCT05209243

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Prostate Cancer
• Stereotactic Body Radiation Therapy

Interventions

Type	Name	Description
RADIATION	SBRT	SBRT (all metastatic lesions)
RADIATION	STANDARD OF CARE	ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment

Timeline

• Start date: 2023-01-26
• Primary completion: 2025-01-01
• Completion: 2027-01-01
• First posted: 2022-01-26
• Last updated: 2023-05-19

Locations

2 sites across 1 country: Spain