Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

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

NCT05849298 · View on ClinicalTrials.gov ↗

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). Approximately 80 participants will be randomized.

Conditions Studied

Interventions

  • DRUG ADT
  • DRUG AAA617
  • DRUG ARPI
  • DRUG AAA517
  • DRUG Piflufolastat F 18

Study Locations (20)

Texas

  • Urology Clinic of North Texas — Dallas
  • Univ of Texas Southwest Med Center — Dallas
  • Rio Grande Urology — El Paso
  • Houston Methodist Hospital — Houston
  • UT Health San Antonio Mays Cancer Center — San Antonio

South Carolina

  • Coastal Cancer Center — Conway
  • Carolina Urologic Research Center — Myrtle Beach
  • Carolina Regional Cancer Center — Myrtle Beach

São Paulo

  • Novartis Investigative Site — São Paulo
  • Novartis Investigative Site — São Paulo

Alabama

  • Urology Associates of Mobile — Mobile

Colorado

  • Rocky Mountain Cancer Centers — Denver

Florida

  • University Of Florida — Jacksonville

Georgia

  • University Cancer and Blood Center LLC — Athens

Indiana

  • Urology Of Indiana — Indianapolis

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2024-01-03
Est. Completion 2026-12-23
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05849298

The ClinicalTrials.gov registry entry for NCT05849298 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prostatic Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which ADT is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05849298 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Texas, South Carolina, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05849298 about?

NCT05849298 is a clinical study titled "A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC". 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...

What is the current status of trial NCT05849298?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2024-01-03. Estimated completion is 2026-12-23.

What conditions does trial NCT05849298 study?

This clinical trial studies the following conditions: Prostatic Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05849298?

The interventions under investigation include: ADT (DRUG), AAA617 (DRUG), ARPI (DRUG), AAA517 (DRUG), Piflufolastat F 18 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05849298?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05849298 being conducted?

This trial has 20 study locations across Alabama, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial