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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: Active Phase 1 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine the Recommended Dose for Expansion (RDE) and corresponding regimen for 225Ac-PSMA-R2 monotherapy in PSMA-positive in: * Group-1 (mCRPC): Participants previously treated with 177Lu-labelled PSMA-targeted RLT (post-177Lu). * Group-2 (mCRPC): Participants not treated previously with 177Lu-labelled PSMA-targeted RLT (pre-177Lu). * Group-3 (mHSPC): Participants not treated previously with 177Lu-labelled PSMA-targeted RLT (pre-177Lu).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2023-11-07 |
| Est. Completion | 2029-11-05 |
| Phase | Phase 1 |
What the registry record for NCT05983198 still lists
NCT05983198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower).
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 lists 12 locations in 7 states (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.
Learn More About Clinical Trials
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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 NCT05983198's enrollment target sits among peer trials
29 609th of 735 higher than 124 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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