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NCT06531499 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
106
Enrollment target
20
Study locations

NCT06531499: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Novartis Pharmaceuticals.

NCT06531499 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 106 participants, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06531499, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
106 participants
Enrollment target
20
Study locations

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).

Primary Outcome

Time activity curve (TAC) will be generated from the amount radioactivity in one given tissue. Time integrated activity coefficient and absorbed dose will be calculated

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer

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
Novartis Pharmaceuticals

1,375 total trials

What NCT06531499 shows while recruiting

NCT06531499 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (46% lower).

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.

NCT06531499 names 20 study sites across 11 states, led by Other, California, North Rhine-Westphalia.

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.

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).

Who is sponsoring clinical trial NCT06531499?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06531499's enrollment target sits among peer trials

106 27th of 69 higher than 43 of 69 other Metastatic Castration-Resistant Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06531499

Source: ClinicalTrials.gov NCT06531499, the US trial registry maintained by the National Library of Medicine. NCT06531499 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.