OncRef

Clinical Trial: NCT03658447

PRINCE (PSMA-lutetium Radionuclide Therapy and ImmuNotherapy in Prostate CancEr)

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Peter MacCallum Cancer Centre, Australia
Information Provided By:Peter MacCallum Cancer Centre, Australia
Last Update Posted:2023-07-28

Study Overview

Brief Summary

This investigator driven study will examine the safety, tolerability and efficacy of the combination of 177Lutetium-PSMA (177Lu-PSMA) and pembrolizumab in patients with metastatic Castration Resistant Prostate Cancer (mCRPC). 177Lu-PSMA is a compound that binds to the extra-cellular domain of the prostate-specific membrane antigen. Pembrolizumab is an antibody targeted against anti-programmed cell death 1 (PD-1).This is a single arm study where all patients will be treated with 177Lu-PSMA for upto 6 doses and pembrolizumab for upto 35 cycles.

Official Title

Phase Ib/II Study of Radionuclide 177Lutetium-PSMA-617 Therapy in Combination With Pembrolizumab for Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC)

Conditions

Metastatic Castration Resistant Prostate Cancer

Intervention / Treatment

  • Drug: Pembrolizumab
  • Drug: 177Lu-PSMA

Other Study ID Numbers

  • PeterMac project no. 18/114

Start Date (Actual)

2019-07-12

Primary Completion Date (Actual)

2022-12-22

Study Completion Date (Actual)

2022-12-22

Enrollment (Actual)

37

Study Type

Interventional

Phase

Phase 1, Phase 2