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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorInstituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

About this trial

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 criteria

Qualifiers

Patients with a histological diagnosis of prostate cancer.

Castration sensitive prostate cancer patients.

Oligometastatic disease defined as less than or equal 3 lesions based on CT and Bone Scan and less than or equal 5 lesions based on Choline or PSMA PET/TC. Bone metastases (including the spine) or/and lymph nodes metastases.

Informed consent is obtained from the patient.

Disqualifiers

Lack of a histological diagnosis of prostate cancer.

Castration resistant prostate cancer patients according to PCWG3[30].

Metastatic disease defined as greater than or equal 3 lesions based on CT and Bone Scan and greater than or equal 5 lesions based on Choline or PSMA PET/TC.

Visceral metastases.

Trial design

Treatments tested in this trial

  • SBRT
  • STANDARD OF CARE

Treatment groups

266 Participants
are divided into 2 treatment groups