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

RECRUITING Phase 1

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

NCT06531499 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).

Interventions

  • DRUG AAA617
  • DRUG Gonadotropin-releasing hormone (GnRH) analogues
  • DRUG Gonadotropin-releasing hormone (GnRH) antagonists

Study Locations (20)

Other

  • Novartis Investigative Site — Aachen
  • Novartis Investigative Site — Berlin
  • Novartis Investigative Site — Essen
  • Novartis Investigative Site — München
  • Novartis Investigative Site — Rostock
  • Novartis Investigative Site — Barcelona
  • Novartis Investigative Site — Bellinzona
  • Novartis Investigative Site — Bern

California

  • University of California LA — Los Angeles
  • Stanford University — Palo Alto

North Rhine-Westphalia

  • Novartis Investigative Site — Cologne
  • Novartis Investigative Site — Wuppertal

Minnesota

  • Mayo Clinic Rochester — Rochester

Missouri

  • Wash U School of Medicine — St Louis

Nebraska

  • Nebraska Cancer Specialists — Omaha

Gelderland

  • Novartis Investigative Site — Nijmegen

A Coruna

  • Novartis Investigative Site — Santiago Compostela

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2024-11-11
Est. Completion 2028-11-24
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06531499

The ClinicalTrials.gov registry entry for NCT06531499 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 106 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 Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which AAA617 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: NCT06531499 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, North Rhine-Westphalia. 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 NCT06531499 about?

NCT06531499 is a clinical study titled "A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study". The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with ...

What is the current status of trial NCT06531499?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2024-11-11. Estimated completion is 2028-11-24.

What conditions does trial NCT06531499 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06531499?

The interventions under investigation include: AAA617 (DRUG), Gonadotropin-releasing hormone (GnRH) analogues (DRUG), Gonadotropin-releasing hormone (GnRH) antagonists (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06531499?

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 NCT06531499 being conducted?

This trial has 20 study locations across California, Minnesota, Missouri, Nebraska, North Rhine-Westphalia. 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