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NCT05983198 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT

A Phase 1 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 1
Development phase
29
Enrollment target
12
Study locations

NCT05983198 is a Phase 1 study of Prostate Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 29 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 12 study locations across 7 states.

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The verdict

NCT05983198, a Phase 1 study of Prostate Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
29 participants
Enrollment target
12
Study locations

Study Summary

This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, \[225Ac\]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients. Enrollment of all participants was not completed. The evaluated radioligand showed acceptable safety but limited benefit in metastatic prostate cancer

Conditions Studied

Prostate Cancer

Interventions

  • DRUG 225Ac-PSMA-R2
  • RADIATION 68Ga-PSMA-R2
  • RADIATION 68Ga-PSMA-11

Study Locations (12)

Other

  • Novartis Investigative Site - Clermont-Ferrand
  • Novartis Investigative Site - Lyon
  • Novartis Investigative Site - Nantes
  • Novartis Investigative Site - Saint-Herblain
  • Novartis Investigative Site - Vandœuvre-lès-Nancy

Quebec

  • Novartis Investigative Site - Montreal
  • Novartis Investigative Site - Montreal

Michigan

  • BAMF Health - Grand Rapids

Minnesota

  • Mayo Clinic Rochester - Rochester

New South Wales

  • Novartis Investigative Site - Darlinghurst

Victoria

  • Novartis Investigative Site - Melbourne

Cote D Or

  • Novartis Investigative Site - Dijon

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2023-11-07
Est. Completion 2029-11-05
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT05983198

The ClinicalTrials.gov registry entry for NCT05983198 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which 225Ac-PSMA-R2 is the first listed.

NCT05983198 reports 12 study locations spanning 7 distinct geographic areas - top geographies include Other, Quebec, Michigan.

Frequently Asked Questions

What is clinical trial NCT05983198 about?

NCT05983198 is a clinical study titled "Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT". This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose ...

What is the current status of trial NCT05983198?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2023-11-07. Estimated completion is 2029-11-05.

What conditions does trial NCT05983198 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT05983198?

The interventions under investigation include: 225Ac-PSMA-R2 (DRUG), 68Ga-PSMA-R2 (RADIATION), 68Ga-PSMA-11 (RADIATION).

Who is sponsoring clinical trial NCT05983198?

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

Where is trial NCT05983198 being conducted?

This trial has 12 study locations across Michigan, Minnesota, New South Wales, Victoria, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.