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New treatment option for Localized Prostate Carcinoma
Official title Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
ClinicalTrials.gov ID: NCT06389786
What this study is testing
- What it's testing
- This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography [PET]/magnetic resonance imaging [MRI]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 85, men only
You may be able to join if
- Male people ≥ 30 and ≤ 85 years old
- Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)
- Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer...
- Planned elective radical prostatectomy with extended pelvic lymph node dissection
- Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery
You likely can't join if
- High-risk cancer planned for neoadjuvant therapy
- Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within...
- Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration
- Clinical oligometastatic disease with \> 3 nodes positive preoperative standard of care imaging of prostate region
- Previous history of pelvic radiation
- Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2
See the full eligibility criteria
- Male people ≥ 30 and ≤ 85 years old
- Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)
- Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling
- Planned elective radical prostatectomy with extended pelvic lymph node dissection
- Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery
- Patient agrees to comply with the investigator instructions
- Patient agrees to comply with the follow-up surveillance schedule
- Have ability to provide full written consent
- High-risk cancer planned for neoadjuvant therapy
- Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications...
- Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration
- Clinical oligometastatic disease with \> 3 nodes positive preoperative standard of care imaging of prostate region
- Previous history of pelvic radiation
- Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2
- History of prior laparoscopic inguinal hernia repair with mesh
- Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
- Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging
- Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
- Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
- Received administration of an investigational drug within 30 days prior to study registration, and/or has planned administration of another investigational product or procedure during participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 30 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.