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NCT07237269 · ClinicalTrials.gov registry record · Phase 2
Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
A Phase 2 study, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT07237269: Recruiting Phase 2 study, sponsored by University of Nebraska.
NCT07237269 is a Phase 2 study that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07237269, a Phase 2 study, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
Study Summary
The advent of PSMA-PET has improved sensitivity and specificity in staging prostate cancer, particularly in intermediate- and high-risk disease. This has created uncertainty in the management of patients with PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e., \<1 cm in smallest diameter). This study evaluates outcomes of enhanced androgen deprivation therapy (ADT) with abiraterone and prednisone compared to standard ADT, both in combination with radiation therapy, in patients with prostate cancer and PSMA-positive but conventionally negative pelvic lymphadenopathy. A total of 140 eligible participants will be randomized to receive either enhanced ADT with abiraterone and prednisone or standard ADT, both with concurrent radiation therapy. Participants will be followed for 5 years after completion of ADT to assess outcomes. The primary objective is to determine whether enhanced ADT improves 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of toxicity, quality of life, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival. Exploratory objectives include evaluation of tumor growth and regression rates using PSA values and assessment of the relationship between treatment outcomes and blood-based heme oxygenase-1 (HO-1) levels.
Primary Outcome
Determine the impact of enhanced ADT with abiraterone/prednisone versus standard ADT on the 5-year failure-free survival of patients with PSMA-positive conventionally negative pelvic lymphadenopathy (i.e. \<1cm in smallest diameter).
Interventions
- RADIATION Radiation Therapy
- DRUG Prednisone
- DRUG Abiraterone
- DRUG Androgen Deprivation Therapy (ADT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2026-04-03 |
| Est. Completion | 2033-04-03 |
| Phase | Phase 2 |
What NCT07237269 shows while recruiting
NCT07237269 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Radiation Therapy is the first listed.
NCT07237269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07237269 about?
NCT07237269 is a clinical study titled "Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer". The advent of PSMA-PET has improved sensitivity and specificity in staging prostate cancer, particularly in intermediate- and high-risk disease. This has created uncertainty in the management of patients with PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e., \<1 cm in smallest ...
What is the current status of trial NCT07237269?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2026-04-03. Estimated completion is 2033-04-03.
What interventions are being tested in trial NCT07237269?
The interventions under investigation include: Radiation Therapy (RADIATION), Prednisone (DRUG), Abiraterone (DRUG), Androgen Deprivation Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT07237269?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07237269's enrollment target sits among peer trials
140 512th of 2000 higher than 1,476 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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