HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)

Prior treatment

• Concurrent enrolment in another clinical study, unless it is a non-therapeutic clinical study
• History of another primary malignancy except for
  • Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of SRT and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
• Uncontrolled pain that contraindicates patient positioning on the radiotherapy table according to investigator
• Patient indicated to or currently treated by cytopenic treatment as chemotherapy or RadioLigand Therapy
• Patient under concomitant treatment that may generate severe gastro-intestinal disorder or genito-urinary disorder

Other illness

• Mental impairment (psychiatric illness/social situations) that may compromise the ability of the patient to give informed consent and comply with the requirements of the study;

Other

• Evidence of symptomatic metastases to the lungs, brain, peritoneum or liver
• Evidence of diffuse metastatic spread to the bone marrow (e.g. positive super bone scan) or the cerebral spinal fluid as per bone scan (no lumbar puncture required).
• Evidence of presence of symptomatic spinal cord compression with indication of neurosurgical decompression.
• Patient with symptomatic and/or high-risk tumor volume-to-bone marrow reserve ratio \> 50%
• Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship;
• Patients unable to undergo medical follow-up in the study for geographical, social or psychological reasons.

• Metastatic prostate cancer with clinical progression after the use of androgen-receptor pathway inhibitor, chemotherapy or any other life-prolonging therapy. Patient could have been treated previously by RadioLigand Therapy (RLT).
• Performance Status \< 3
• Bone and/or lymph node metastases based on conventional (CT and bone scan) or metabolic imaging
• Bone and/or lymph node metastases suitable for SRT, according to the investigator
• Adequate organ function:
  • Absolute Neutrophil Count (ANC) ≥ 1000/mm3 or
  • Platelet Count ≥ 50 000/mm3 or
  • Haemoglobin ≥ 8 g/dL (allowing transfusion or other intervention to achieve this minimum haemoglobin)
• Age ≥ 18 years at time of study entry
• Written informed consent obtained from the patient prior to performing any protocol-related
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
• Patient has valid health insurance
• Life time expected \> 3 months