Lymphofollicular Hyperplasia Clinical Trials

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Abiraterone/Prednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 30
Healthy Volunteers: f
View:

• Histopathologically proven diagnosis of local prostate cancer. Biopsies will be confirmed by UNMC pathology review if collected outside our institution.

• Targetable PSMA-avid pelvic lymph node measuring \<1cm in short axis diameter.

• No prior definitive treatment or intervention received.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 14 days prior to registration.

• Age ≥ 30 years.

• Patient must be able to provide study-specific informed consent prior to study entry.

• Patient must be able to swallow medications.

Locations
United States
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Contact Information
Primary
Taylor Johnson, MA
taylora.johnson@unmc.edu
402-559-4596
Backup
IIT OFFICE
iitoffice@unmc.edu
402-559-4596
Time Frame
Start Date: 2026-04-03
Estimated Completion Date: 2033-04-03
Participants
Target number of participants: 140
Treatments
Active_comparator: Standard ADT
Participants receive standard androgen deprivation therapy (ADT) in combination with radiation therapy.
Experimental: Abiraterone/Prednisone + Standard ADT
Participants receive Abiraterone/Prednisone in addition to standard androgen deprivation therapy (ADT) in combination with radiation therapy
Sponsors
Leads: University of Nebraska

This content was sourced from clinicaltrials.gov