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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT07237269
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Androgen Deprivation Therapy (ADT) — DRUG
    Standard hormone therapy used for prostate cancer treatment
  • Abiraterone — DRUG
    Abiraterone administered as part of enhanced androgen deprivation therapy
  • Prednisone — DRUG
    Prednisone administered in combination with abiraterone
  • Radiation Therapy — RADIATION
    Radiation therapy administered per protocol to the prostate and/or pelvic lymph nodes

Study Details

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.

Key Dates

Start date
Apr 3, 2026
Status verified
Nov 2025
Primary completion
Apr 3, 2033
Completion
Apr 3, 2033

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

5-year failure-free survival rate [ Time Frame: From randomization up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Heather Mittelstedt, RN
[email protected]
402-559-8287
Michael Baine, MD/PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Omaha, NE

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Nebraska Medical Center· Omaha, NE

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