ACTIVE_NOT_RECRUITING

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

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Conditions

Prostatic NeoplasmProstate-specific membrane antigen (PSMA)Lutetium [177Lu] vipivotide tetraxetan (AAA617)Androgen Receptor Pathway Inhibitors (ARPI)EnzalutamideDarolutamideApalutamideCastration Resistant Prostate CancerAndrogen Deprivation Therapygallium [68Ga] gozetotide (AAA517)piflufolastat F 18

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 80 participants will be randomized.

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

Quick Facts

Study Start:2024-01-03
Study Completion:2030-05-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05849298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Urology Associates of Mobile
Mobile, Alabama, 36608
United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
United States
University Of Florida
Jacksonville, Florida, 32218
United States
University Cancer and Blood Center LLC
Athens, Georgia, 30607
United States
Urology Of Indiana
Indianapolis, Indiana, 46254
United States
Unity Point Clinic
Des Moines, Iowa, 50323
United States
Urology Cancer Center PC
Omaha, Nebraska, 68130
United States
Associated Med Professionals of NY
Syracuse, New York, 13210
United States
Oregon Urology Institute
Springfield, Oregon, 97477
United States
Wellspan York Hospital
York, Pennsylvania, 17403
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
United States
Urology Clinic of North Texas
Dallas, Texas, 75231
United States
Univ of Texas Southwest Med Center
Dallas, Texas, 75390-9034
United States
Rio Grande Urology
El Paso, Texas, 79912
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03
Study Completion Date2030-05-18

Study Record Updates

Study Start Date2024-01-03
Study Completion Date2030-05-18

Terms related to this study

Keywords Provided by Researchers

  • Prostate-specific membrane antigen (PSMA)
  • Lutetium [177Lu] vipivotide tetraxetan (AAA617)
  • Androgen Receptor Pathway Inhibitors (ARPI)
  • Enzalutamide
  • Darolutamide
  • Apalutamide
  • Castration Resistant Prostate Cancer
  • Androgen Deprivation Therapy
  • gallium [68Ga] gozetotide (AAA517)
  • piflufolastat F 18

Additional Relevant MeSH Terms

  • Prostatic Neoplasm