Prostate CancerPhase 2NCT07237269
Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer
A Phase 2 study testing Androgen Deprivation Therapy (ADT), Abiraterone and Prednisone in people with Prostate Cancer, run by University of Nebraska at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Androgen Deprivation Therapy (ADT), Abiraterone and Prednisone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 3 Apr 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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.
- Acquired Immune Deficiency Syndrome (AIDS) based upon the current Centers for Disease Control and Prevention definition that is being treated with contraindicated medications, including but not limited to Atazanavir, Saquinavir, Ritonavir, Indinavir, or Nelfinavir. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Uncontrolled seizures or seizures in the past 3 months. Patients can enroll if their seizures have been well-controlled for >3 months on antiseizure medications.
- Gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE version 5 grade 3 or greater within 30 days prior to registration.
- History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration.
- Total bilirubin ≥1.5X upper limit of normal (ULN) [except for subjects with Gilbert's disease, in which case total bilirubin not to exceed 10X ULN], alanine (ALT) and aspartate (AST) aminotransferase >= 2.5X ULN.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Heather Mittelstedt, RN, 402-559-8287, hmittelstedt@unmc.edu
Michael Baine, MD/PhD
About this study
Official title: Abiraterone/Prednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy
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.
Read more
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.
Read the detailed description
The advent of PSMA-PET has allowed greater sensitivity and specificity when staging prostate cancers, particularly intermediate and high-risk prostate cancers. This has created a gap in knowledge regarding the treatment of patients who have PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e. <1cm in smallest diameter). The purpose of this study is to compare outcomes of enhanced ADT with abiraterone and prednisone and standard ADT, both alongside radiation therapy, in prostate cancer patients with PSMA-positive but conventionally negative pelvic lymphadenopathy. We hypothesize that enhanced ADT with abiraterone and prednisone is superior to standard ADT for the treatment of prostate cancer patients with PSMA-positive but conventionally negative pelvic lymphadenopathy. We further hypothesize that standard ADT will be associated with a lower rate of adverse events. Patients will be followed for 5 years after completion of ADT to evaluate outcomes. The primary objective will be to determine if enhanced ADT has superior 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of chronic toxicities, quality of life impact, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival.
- Conditions
- Prostate Cancer
- Being tested
- Androgen Deprivation Therapy (ADT), Abiraterone, Prednisone, Radiation Therapy
- Keywords
- PSMA-PET, Prostate Cancer, Androgen Deprivation Therapy, Abiraterone, Radiation Therapy, Pelvic Lymphadenopathy, Hormone Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen Deprivation Therapy (ADT)Drug
Also called ADT
Standard hormone therapy used for prostate cancer treatment
AbirateroneDrug
Abiraterone administered as part of enhanced androgen deprivation therapy
PrednisoneDrug
Prednisone administered in combination with abiraterone
Radiation TherapyRadiation
Radiation therapy administered per protocol to the prostate and/or pelvic lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Standard ADT | Active comparator | Participants receive standard androgen deprivation therapy (ADT) in combination with radiation therapy. Receives: 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 Receives: Drug: Androgen Deprivation Therapy (ADT); Drug: Abiraterone; Drug: Prednisone; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From randomization up to 5 years
Secondary outcomes (8)
Toxicity in both arms from 3 months to 2 years post-ADT.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 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)
Using IPSS (International Prostate Symptom Score). The quality-of-life measures will be summarized using descriptive statistics at each time point collected as n, mean, SD, median, minimum, and maximum. The IPSS score ranges from 0 to 35, with higher scores indicating worse urinary symptoms.
Measured: 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)
Using FACT-P (Functional Assessment of Cancer Therapy-Prostate.) The quality of life measures will be summarized using descriptive statistics at each time point collected as n, mean, SD, median, minimum, and maximum. The FACT-P score ranges from0 to 156, with higher scores indicating better quality of life.
Measured: From 3 months to 2 Years post-ADT
Evaluate local progression-free survival (i.e., failure-free survival excluding biochemical failure).
Evaluate progression-free survival (i.e., failure-free survival excluding biochemical failure). Progression-free survival will be estimated with the Kaplan-Meier method and will be compared between treatment arms with the log-rank test. The 5-year survival rates will be estimated with a 95% confidence interval. Time to local failure is defined as time since randomization to disease progression within the intact prostate. Regional, metastases, and deaths are treated as competing events.
Measured: From randomization up to 5 years
Evaluate locoregional progression-free survival (i.e., failure-free survival excluding biochemical failure).
Evaluate progression-free survival (i.e., failure-free survival excluding biochemical failure). Progression-free survival will be estimated with the Kaplan-Meier method and will be compared between treatment arms with the log-rank test. The 5-year survival rates will be estimated with a 95% confidence interval.
Time to locoregional failure is defined as time since randomization to disease progression within the pelvis and pelvic lymph nodes. Metastases and deaths are treated as competing events.
Measured: From randomization up to 5 years
Evaluate 5-year overall survival
Overall survival will be estimated with the Kaplan-Meier method and will be compared between treatment arms with the log-rank test. The 5-year survival rates will be estimated with a 95% confidence interval. Overall survival is defined as the time since the date of randomization to the date of death or last follow-up.
Measured: From randomization up to 5 years
Evaluate 5-year cancer-specific survival
Cumulative incidence methods will be used to estimate 5-year rates (with 95% CI) of LC, LRC, and DM while accounting for death as a competing event. Cancer-specific survival is defined as time since the date of randomization to the date of death due to cancer diagnosis or treatment or last follow-up. Deaths due to other causes are treated as competing events.
Measured: From randomization up to 5 years
Evaluate 5-year metastasis-free survival.
Time to distant metastasis is defined as time since date of randomization to distant metastases in para-aortic lymph nodes and distant organs or last follow-up. Locoregional failures and deaths are treated as competing events.
Measured: From randomization up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Sep 2026
- Primary completion3 Apr 2033 (estimated)
- Study completion3 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Baine, MD, PhD, Principal investigator, Fred & Pamela Buffett Cancer Center, University of Nebraska, 987521 Nebraska Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237269
- Sponsor's protocol ID
- 787-25-FB
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No Plan to Share
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abiraterone/Prednisone + Standard ADT vs Standard ADT for Prostate Cancer Patients With PSMA-Positive Conventional Imaging Negative Pelvic Lymphadenopathy
- ClinicalTrials.gov ID
- NCT07237269
- Acronym / sponsor ID
- 787-25-FB
- Conditions
- Prostate Cancer
- Keywords
- PSMA-PET, Prostate Cancer, Androgen Deprivation Therapy, Abiraterone, Radiation Therapy, Pelvic Lymphadenopathy, Hormone Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 3 Apr 2033 (estimated)
- Study completion
- 3 Apr 2033 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The advent of PSMA-PET has allowed greater sensitivity and specificity when staging prostate cancers, particularly intermediate and high-risk prostate cancers. This has created a gap in knowledge regarding the treatment of patients who have PSMA-positive but conventionally negative pelvic lymphadenopathy (i.e. <1cm in smallest diameter). The purpose of this study is to compare outcomes of enhanced ADT with abiraterone and prednisone and standard ADT, both alongside radiation therapy, in prostate cancer patients with PSMA-positive but conventionally negative pelvic lymphadenopathy. We hypothesize that enhanced ADT with abiraterone and prednisone is superior to standard ADT for the treatment of prostate cancer patients with PSMA-positive but conventionally negative pelvic lymphadenopathy. We further hypothesize that standard ADT will be associated with a lower rate of adverse events. Patients will be followed for 5 years after completion of ADT to evaluate outcomes. The primary objective will be to determine if enhanced ADT has superior 5-year failure-free survival compared to standard ADT. Secondary objectives include evaluation of chronic toxicities, quality of life impact, biochemical progression-free survival, cancer-specific survival, overall survival, and metastasis-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ADT | Active comparator | Drug: Androgen Deprivation Therapy (ADT), Radiation: Radiation TherapyParticipants receive standard androgen deprivation therapy (ADT) in combination with radiation therapy. |
| Abiraterone/Prednisone + Standard ADT | Experimental | Drug: Androgen Deprivation Therapy (ADT), Drug: Abiraterone, Drug: Prednisone, Radiation: Radiation TherapyParticipants receive Abiraterone/Prednisone in addition to standard androgen deprivation therapy (ADT) in combination with radiation therapy |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen Deprivation Therapy (ADT)Also: ADTStandard hormone therapy used for prostate cancer treatment | Drug | Abiraterone/Prednisone + Standard ADT, Standard ADT |
| AbirateroneAbiraterone administered as part of enhanced androgen deprivation therapy | Drug | Abiraterone/Prednisone + Standard ADT |
| PrednisonePrednisone administered in combination with abiraterone | Drug | Abiraterone/Prednisone + Standard ADT |
| Radiation TherapyRadiation therapy administered per protocol to the prostate and/or pelvic lymph nodes | Radiation | Abiraterone/Prednisone + Standard ADT, Standard ADT |
Primary outcome
5-year failure-free survival rate
Time frame: From randomization up to 5 years
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).
8 secondary outcomes
Toxicity in both arms from 3 months to 2 years post-ADT.
Time frame: 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)
Time frame: 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)
Time frame: From 3 months to 2 Years post-ADT
Evaluate local progression-free survival (i.e., failure-free survival excluding biochemical failure).
Time frame: From randomization up to 5 years
Evaluate locoregional progression-free survival (i.e., failure-free survival excluding biochemical failure).
Time frame: From randomization up to 5 years
Evaluate 5-year overall survival
Time frame: From randomization up to 5 years
Evaluate 5-year cancer-specific survival
Time frame: From randomization up to 5 years
Evaluate 5-year metastasis-free survival.
Time frame: From randomization up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. No Plan to Share
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Baine, MD, PhD principal investigator
Fred & Pamela Buffett Cancer Center, University of Nebraska, 987521 Nebraska Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgen Deprivation Therapy (ADT), Abiraterone and Prednisone in people with Prostate Cancer, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Johnson, MA (402-559-4596, taylora.johnson@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year failure-free survival rate (time frame: From randomization up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.