OncRef

Clinical Trial: NCT05655715

Checkpoint Inhibitors and SBRT for MCRPC

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Herlev and Gentofte Hospital
Information Provided By:Herlev and Gentofte Hospital
Last Update Posted:2024-10-16

Study Overview

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).

Official Title

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

Conditions

Prostate Cancer Metastatic, Castrate Resistant Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Prostate Cancer Stage IV

Intervention / Treatment

  • Radiation: Stereotactic body radiotherapy
  • Drug: Ipilimumab Injection [Yervoy]
  • Drug: Nivolumab Injection [Opdivo]
  • Procedure: Biopsies

Other Study ID Numbers

  • UR1840

Start Date (Actual)

2019-11-25

Primary Completion Date (Actual)

2024-08-30

Study Completion Date (Actual)

2024-08-30

Enrollment (Actual)

90

Study Type

Interventional

Phase

Phase 2