Spots Global Cancer Trial Database for Checkpoint Inhibitors and SBRT for mCRPC

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Trial Identification

Brief Title: Checkpoint Inhibitors and SBRT for mCRPC

Official Title: Randomised Phase 2 Trial of Stereotactic Body Radiation Therapy, SBRT in Combination With Checkpoint Inhibitors in Metastatic Castration-resistant Prostate Cancer

Study ID: NCT05655715

Conditions

Prostate Cancer Metastatic

Castrate Resistant Prostate Cancer

Metastatic Castration-resistant Prostate Cancer

Prostate Cancer Stage IV

Interventions

Stereotactic body radiotherapy

Ipilimumab Injection [Yervoy]

Nivolumab Injection [Opdivo]

Biopsies

Study Description

Brief Summary: The goal of this investigator-initiated, single-center, and randomized phase II trial is to investigate the potential synergistic effect of combining stereotactic body radiotherapy of a single soft tissue- or bone metastasis with ipilimumab and nivolumab in patients with mCRPC and perform translational analyses on tissue and blood, searching for predictive biomarkers of efficacy and toxicity. Participants will be randomized to receive ipilimumab and nivolumab with or without stereotactic body radiotherapy (SBRT).

Detailed Description: The participants receive treatment for 52 weeks, including four cycles of ipilimumab and nivolumab with or without concomitant SBRT (24 Gray in three fractions) to a single soft tissue or bone metastasis, followed by 10 cycles of nivolumab. Participants are followed until progression, death, or for 12 months after the end of treatment. Biopsies from metastatic sites are collected at baseline, before the third treatment, and at the end of treatment. Blood sampling for immune monitoring and circulating tumor DNA is performed consecutively at baseline and every radiographic assessment.