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

NCT07237269 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 787-25-FB
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

PSMA-PET; Prostate Cancer; Androgen Deprivation Therapy; Abiraterone; Radiation Therapy; Pelvic Lymphadenopathy; Hormone Therapy

Outcome Measures

Primary Outcomes (1)

• 5-year failure-free survival rate

  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).

  From randomization up to 5 years

Secondary Outcomes (8)

• Toxicity in both arms from 3 months to 2 years post-ADT.

  From 3 months to 2 years post-ADT

• Evaluate and compare patient-reported symptom outcomes in both arms from 3 months to 2 years post-ADT. (IPSS)

  From 3 months to 2 Years post-ADT

• Evaluate and compare patient-reported symptom outcomes in both arms from 3 months to 2 years post-ADT. (FACT-P)

  From 3 months to 2 Years post-ADT

• Evaluate local progression-free survival (i.e., failure-free survival excluding biochemical failure).

  From randomization up to 5 years

• Evaluate locoregional progression-free survival (i.e., failure-free survival excluding biochemical failure).

  From randomization up to 5 years

Study Arms (2)

Standard ADT

ACTIVE COMPARATOR

Participants receive standard androgen deprivation therapy (ADT) in combination with radiation therapy.

Drug: Androgen Deprivation Therapy (ADT); Radiation: Radiation Therapy

Abiraterone/Prednisone + Standard ADT

EXPERIMENTAL

Participants receive Abiraterone/Prednisone in addition to standard androgen deprivation therapy (ADT) in combination with radiation therapy

Drug: Androgen Deprivation Therapy (ADT); Drug: Abiraterone; Drug: Prednisone; Radiation: Radiation Therapy

Interventions

Androgen Deprivation Therapy (ADT) DRUG

Standard hormone therapy used for prostate cancer treatment

Abiraterone/Prednisone + Standard ADT; Standard ADT

Prednisone DRUG

Prednisone administered in combination with abiraterone

Abiraterone/Prednisone + Standard ADT

Radiation Therapy RADIATION

Radiation therapy administered per protocol to the prostate and/or pelvic lymph nodes

Abiraterone/Prednisone + Standard ADT; Standard ADT

Abiraterone DRUG

Abiraterone administered as part of enhanced androgen deprivation therapy

Abiraterone/Prednisone + Standard ADT

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease).
• Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse.
• Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but are not limited to, inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), and genetic disorders that risk increased sensitivity to radiation therapy.
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months prior to registration.
• Congestive heart failure (NYHA functional capacity class II or greater).
• Transmural myocardial infarction within the last 3 months prior to registration.
• History of stroke or transient ischemic attack within 3 months prior to registration.
• Currently uncontrolled diabetes mellitus.
• Ongoing arrhythmias of Grade \>2 \[National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE), version 5.03\]; chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
• Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) in the past month.
• Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; abiraterone; Prednisone; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics

Central Study Contacts

Taylor Johnson, MA

CONTACT

402-559-4596; taylora.johnson@unmc.edu

IIT OFFICE

CONTACT

402-559-4596; iitoffice@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: April 3, 2026
• Primary Completion (Estimated): April 3, 2033
• Study Completion (Estimated): April 3, 2033
• Last Updated: April 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)