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NCT05849298 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
A Phase 2 study of Prostatic Neoplasm, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 20
- Study locations
NCT05849298: Active Phase 2 study of Prostatic Neoplasm, sponsored by Novartis Pharmaceuticals.
NCT05849298 is a Phase 2 study of Prostatic Neoplasm that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 49 participants, below the 247-participant average among 9 other Prostatic Neoplasm trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05849298, a Phase 2 study of Prostatic Neoplasm, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PSA response is defined as the time of PSA nadir value of =\< 0.2 ng/mL is confirmed by a second (the next) PSA measurement at least 4 weeks later
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
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2024-01-03 |
| Est. Completion | 2026-12-23 |
| Phase | Phase 2 |
What the registry record for NCT05849298 still lists
NCT05849298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 247-participant average among 9 other Prostatic Neoplasm trials with a reported enrollment target (80% lower).
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.
NCT05849298 names 20 study sites across 13 states, led by Texas, South Carolina, São Paulo.
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.
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).
Who is sponsoring clinical trial NCT05849298?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05849298's enrollment target sits among peer trials
49 9th of 9 higher than 1 of 9 other Prostatic Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasm 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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