Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
A prospective, open label phase 2 clinical trial assessing safety, complications and feasibility of radical prostatectomy (RARP) plus local stereotactic body radiotherapy (SBRT) to bone metastases in combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.
• Age 18 years or older and willing and able to provide informed consent;
• Stage cT1 ≤ cT3b, Clinical resectable
• Gleason score ≥ 6
• M1
‣ ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
⁃ Absence of PSMA uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the European Association of Urology (EAU) guidelines.
⁃ No visceral metastasis
⁃ Metastases suitable for stereotactic body radiotherapy
⁃ Non symptomatic bone lesions
• Eligible for surgery