Clinical Trial · NCT04419402

Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer

Overview

This phase 2 randomised clinical trial will investigate the activity and safety of adding Lu-PSMA to enzalutamide in patients with metastatic castrate resistant prostate cancer (mCRPC) not previously treated with chemotherapy.

Sponsor

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Phase

Phase 2

Contacts

Louise Emmett, MBBS, FRACP (STUDY_CHAIR)

ClinicalTrials.gov

NCT04419402

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

PSMA-617

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

Significant PSMA avidity on 68Ga-PSMA PET/CT, defined as SUVmax \>15 at a single site (regardless of lesion size) and SUV max \>10 at sites of disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact)
\>5 bone metastases \*
Castration-resistant prostate cancer (defined as disease progressing despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone agonist or antagonist).
Prior treatment with abiraterone \* Based on conventional imaging (CT and/or bone scan)
Target or non-target lesions according to RECIST 1.1
De novo metastatic disease (M1) at initial diagnosis \*
Documented histopathology of prostate adenocarcinoma (no features of neuroendocrine carcinoma) OR
Progressive disease with rising PSA defined by PCWG3 criteria (sequence of 2 rising values at a minimum of 1-week intervals) AND PSA ≥ 5 ng/mL.

Exclusion

Prior treatment with enzalutamide, darolutamide, or apalutamide. Prior treatment with abiraterone is allowed.
Prior chemotherapy for mCRPC. Prior docetaxel in castration-sensitive setting is permitted
68Ga-PSMA PET/CT SUVmax \< 10 at a site of measurable disease \> 10mm