RecruitingNot ApplicableNCT05209243

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.


Sponsor

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Enrollment

266 participants

Start Date

Jan 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted radiation (stereotactic body radiotherapy, or SBRT) to hormone therapy improves outcomes in men with newly diagnosed prostate cancer that has spread to a small number of sites (called oligometastatic disease). SBRT delivers precise, high-dose radiation directly to tumors. **You may be eligible if...** - You have been diagnosed with prostate cancer that is still responsive to hormone-lowering treatments (castration-sensitive) - You have a limited number of metastatic spots — 3 or fewer on CT/bone scan, or 5 or fewer on a specialized PET scan - Your metastases are in the bones or lymph nodes (not internal organs) - Your bone marrow and organ function are within acceptable ranges **You may NOT be eligible if...** - Your prostate cancer has become resistant to hormone therapy - You have more than 3 or 5 lesions (depending on scan type) - You have metastases in internal organs (visceral disease) - You have previously received certain advanced hormone therapies or docetaxel chemotherapy - You are participating in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSBRT

SBRT (all metastatic lesions)

RADIATIONSTANDARD OF CARE

ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment


Locations(2)

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

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NCT05209243


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