Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 23-009377
NCT ID: NCT06389786
Sponsor Protocol Number: MC230504
About this study
This is a prospective, single-arm investigative trial. Patients with high risk prostate cancer, defined by AUA guidelines, who elect robotic assisted radical prostatectomy with an extended pelvic lymph node dissection will have standard of care preoperative imaging with CT/MRI + NM Bone Scan compared with 18F-rhPSMA-7.3 PET/MRI. Preoperative clinicopathologic variables including PSA, prostate biopsy pathology results reported as Gleason grade and percent positivity, imaging tests and demographic information will be abstracted from the electronic health record at enrollment.
Intraoperatively the lymph node packets will be labeled according to laterality and location to include internal iliac, external iliac, common iliac, obturator packet, retropubic and sacral. Following surgery there will be an expert pathologic review of the sampled lymph nodes by a dedicated GU pathologist and a corresponding comparison with preoperative imaging and patient risk AUA prostate cancer risk score.
Following surgery, participants will visit the study doctor for their standard follow-up visits at 6 weeks, 3 months, 6 months, 9 months, and 12 months with corresponding PSA surveillance with adjuvant imaging or treatment as part of standard of care.
Proposed study is intended to be carried out at the Mayo Clinic in Jacksonville, Florida. Urologist Dr. Ram Anil Pathak will be the responsible Principal Investigator, primary surgeon, and counselor for the study patients. The PI and his assigned team will conduct the follow-up visits (6 weeks, 3-, 6-, 9- and 12-months) at the Urology Clinic of Mayo Clinic in Florida.
Patients will be assessed for safety by regular evaluation of adverse events (AE) as clinically indicated.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Male subjects with at least age of 30 to 85.
- Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy with extended lymph node dissection).
- Primary diagnosis of untreated 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 18F-rhPSMA-7.3 PSMA.
- Patient has the willingness to comply with instruction of the investigator.
- Patient has the willingness to comply with follow-up surveillance.
- Have ability to provide full written consent.
Exclusion Criteria
- High-risk cancer planned for neoadjuvant therapy.
- Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens.
- Clinical oligometastatic disease with > 3 nodes positive on 18F-rhPSMA-7.3 PSMA.
- Previous history of pelvic radiation.
- Patients with obesity defined as BMI > 40 kg/m^2.
- History of prior mesh for inguinal hernia repair.
- 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, and/or has planned administration of another investigational product or procedure during participation in this study.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/27/23. Questions regarding updates should be directed to the study team contact.