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A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

NCT05849298 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium \[177Lu\] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans).

Conditions

  • Prostatic Neoplasm

Interventions

DRUG

AAA617

Administration intravenously once every 6 weeks (1 cycle) for 6 cycles

DRUG

AAA517

Single intravenous dose of approx. 150 Megabecquerel (MBq) prior PSMA-PET scans

DRUG

Piflufolastat F 18

Single intravenous dose of approx. 333 Megabecquerel (MBq) prior PSMA-PET scans

DRUG

ARPI

Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator

DRUG

ADT

as prescribed by the local investigator

OTHER

Best supportive care

as prescribed by the local investigator

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2026-12-23
Completion
2026-12-23
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Singapore
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849298 on ClinicalTrials.gov