Clinical Trials Logo
  1. Home
  2. Prostatic Neoplasm
  3. NCT05849298

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

Prostatic Neoplasm Clinical Trial

Official title:
An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer

Clinical Trial 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). Approximately 120 participants will be randomized.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05849298
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Status Recruiting
Phase Phase 2
Start date January 3, 2024
Completion date December 21, 2028
View Details
See also
  Status Clinical Trial Phase
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Recruiting NCT05667636 - Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP Phase 2
Terminated NCT01996696 - Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate Phase 2
Completed NCT01431391 - Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer Phase 2
Completed NCT03289130 - Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness
Recruiting NCT04462926 - Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed N/A
Completed NCT00001446 - A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer Phase 2
Completed NCT02729103 - Treatment Patterns in Metastatic Prostate Cancer N/A
Completed NCT00956228 - Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer Phase 1/Phase 2
Completed NCT00126854 - High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation N/A
Completed NCT00247312 - Pd-103 Dose De-Escalation for Early Stage Prostate Cancer: A Prospective Randomized Trial Phase 3
Completed NCT00174863 - Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer Phase 2
Terminated NCT04221828 - Trial of NanoPac Focal Therapy for Prostate Cancer Phase 2
Completed NCT00001266 - A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma Phase 2
Active, not recruiting NCT03935282 - Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors N/A
Completed NCT03693742 - MSG Use With 18F-DCFPyL PET/CT Imaging N/A
Recruiting NCT06236789 - Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer
Completed NCT02966535 - The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial N/A
Completed NCT02977143 - Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery N/A
Completed NCT00252460 - CT/MRI Co-registration Prostate Cancer Phase 1