Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorPeter MacCallum Cancer Centre, Australia

About this trial

This phase 1b trial is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) and pembrolizumab in patients with metastatic castration resistant prostate cancer (mCRPC).

Eligibility criteria

Qualifiers

Patient must have provided written informed consent using the LumOnate Patient Information and Consent Form (PICF)

Patient must be ≥ 18 years of age at Screening

Willing and able to comply with treatment schedule, laboratory testing, and other requirements of the study

Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation

Disqualifiers

Prior chemotherapy for mCRPC. Prior docetaxel is permitted if given in the setting of hormone sensitive disease

Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax < 10

Extensive marrow disease defined by a "Super Scan" on bone scintigraphy or diffuse marrow infiltration on PSMA PET

Active brain metastases or leptomeningeal metastases

Trial design

Treatments tested in this trial

  • Olaparib (300 mg BID)
  • Pembrolizumab
  • 177Lu-PSMA-I&T

Treatment groups

20 Participants
are divided into 1 treatment group