New combo therapy aims to stop prostate cancer spread in high-risk patients

NCT ID NCT07237269

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study is for men with prostate cancer that has spread to pelvic lymph nodes only detectable by a special PSMA scan. It compares standard hormone therapy plus radiation to a stronger combination adding abiraterone and prednisone. The goal is to see if the stronger treatment improves 5-year survival without cancer returning. About 140 participants will be followed for 5 years after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histopathologically proven diagnosis of local prostate cancer. Biopsies will be confirmed by UNMC pathology review if collected outside our institution. 2. Targetable PSMA-avid pelvic lymph node measuring \<1cm in short axis diameter. 3. No prior definitive treatment or intervention received. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 14 days prior to registration. 5. Age ≥ 30 years. 6. Patient must be able to provide study-specific informed consent prior to study entry. 7. Patient must be able to swallow medications. Exclusion Criteria: 1. Evidence of distant metastatic disease outside the pelvic lymph nodes (including osseous pelvic disease). 2. 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. 3. 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. 4. Severe, active co-morbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months prior to registration. 2. Congestive heart failure (NYHA functional capacity class II or greater). 3. Transmural myocardial infarction within the last 3 months prior to registration. 4. History of stroke or transient ischemic attack within 3 months prior to registration. 5. Currently uncontrolled diabetes mellitus. 6. 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. 7. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) in the past month. 8. Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease. 9. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. 10. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. 11. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects. 12. 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. 13. 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. 14. Gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE version 5 grade 3 or greater within 30 days prior to registration. 15. History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration. 16. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

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