Study design and data capture
prostate, pain
PROSTATE
This phase I open-label interventional study recruited patients at Haukeland University Hospital, Bergen, Norway. The study consisted of two study parts, investigating the safety and tolerability of combining either cryoablation and iDC treatment (first part), or cryoablation, iDC treatment and immune checkpoint inhibitor therapy (second part), illustrated in Fig. Study overview. Generally, participants attended 14 study-specific visits from inclusion to 52 weeks after the CryoIT, with a follow-up period of 72 months. The CryoIT procedure was performed during visit 4 (day 0). Medications, vital signs, and results from the physical examinations and routine laboratory blood analyses were protocolled. Safety assessments were performed during all post-treatment visits. Imaging was performed concomitantly by MRI of the spinal column, pelvic region and prostate gland, whole-body PET/CT with F18-fluorodeoxyglucose, and radionuclide bone scan with [Moreover, health-related quality of life (HRQoL) forms, visual analog scale (VAS) pain measurements, and blood samples were collected as depicted in Fig. 