Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07237269 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Apr 3, 2026 to Oct 15, 2026 Study description expanded, about 177 wordsv3 Show 1 more changeShow less
    • Study description expanded, about 177 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 1, 2026 to Apr 3, 2026 · Primary and study completion dates: Feb 1, 2033 to Apr 3, 2033 · Interventions: Hormone therapy (Drug) to Abiraterone (Drug), Androgen Deprivation Therapy (ADT) (Drug), Prednisone (Drug), Radiation Therapy (Radiation) · 3 morev2 Show 6 more changesShow less
    • Start date: Feb 1, 2026 to Apr 3, 2026
    • Primary and study completion dates: Feb 1, 2033 to Apr 3, 2033
    • Interventions: Hormone therapy (Drug) to Abiraterone (Drug), Androgen Deprivation Therapy (ADT) (Drug), Prednisone (Drug), Radiation Therapy (Radiation)
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised
    • Study title shortened, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07237269
Lead Sponsor University of Nebraska
Conditions Prostate Cancer
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov