Is NCT07237269 recruiting in Omaha, NE?

Yes, NCT07237269 is currently recruiting participants at its Omaha, NE location. This prostate cancer clinical trial is actively enrolling qualified participants.

How do I join the prostate cancer clinical trial in Omaha?

To join this clinical trial in Omaha, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Omaha clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Prostate Cancer Clinical Trial in Omaha, NE

About This Prostate Cancer Study in Omaha

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.

Sponsor: University of Nebraska

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Omaha?

Yes, this clinical trial (NCT07237269) has an active research site in Omaha, NE that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Prostate Cancer Treatment Options in Omaha, NE

If you're searching for prostate cancer treatment options in Omaha, NE, this clinical trial (NCT07237269) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Omaha research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced prostate cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all prostate cancer clinical trials near you to find additional studies recruiting in your area.

Prostate Cancer Clinical Trial in Omaha, NE

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