Clareo Health | HIghly MetAstatic Life Prolonging Therapy-Resistant Prostate Cancer: Role of Stereotactic Radiotherapy for Bone and Lymph Node Metastases (HIMARS)
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:
1. Absolute Neutrophil Count (ANC) ≥ 1000/mm3 or
2. Platelet Count ≥ 50 000/mm3 or
3. 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
You may not be if
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%
Concurrent enrolment in another clinical study, unless it is a non-therapeutic clinical study
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;
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.
History of another primary malignancy except for
1. 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
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
3. 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
