Trial Title:
Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer
NCT ID:
NCT06389786
Condition:
Localized Prostate Carcinoma
Oligometastatic Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Prostatic Neoplasms
Lymphatic Metastasis
Fluorides
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Bilateral Pelvic Lymph Node Dissection
Description:
Undergo bilateral pelvic lymph node dissection
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo tissue sample collection
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Other name:
Bone Scintigraphy
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Intervention type:
Other
Intervention name:
Flotufolastat F-18 Gallium
Description:
Given IV
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Other name:
(18F)-rhPSMA-7.3
Other name:
18F-rhPSMA-7.3
Other name:
18FrhPSMA-7.3
Other name:
F-18-rhPSMA-7.3
Other name:
Fluorine F 18 Radiohybrid PSMA-7.3
Other name:
Fluorine F 18 rhPSMA-7.3
Other name:
Fluorine-18 rhPSMA-7.3
Other name:
Posluma
Other name:
rhPSMA-7.3 (18F)
Intervention type:
Procedure
Intervention name:
Laparoscopic Radical Prostatectomy with Robotics
Description:
Undergo robotic radical prostatectomy
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Other name:
RARP
Other name:
Robot-assisted Radical Prostatectomy
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI or PET/MRI
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/MRI
Arm group label:
Screening (18F-rhPSMA-7.3 PET/MRI)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Summary:
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. PSMA
PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is
procedure in which a small amount of radioactive glucose (sugar) is injected into a vein,
and a scanner is used to make detailed, computerized pictures of areas inside the body
where the glucose is used. Because cancer cells often use more glucose than normal cells,
the pictures can be used to find cancer cells in the body. MRI is procedure in which
radio waves and a powerful magnet linked to a computer are used to create detailed
pictures of areas inside the body. These pictures can show the difference between normal
and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/
MRI may improve predicting which patients are at risk of lymph node metastases and who
are suitable candidates for pelvic lymph node dissection in patients with localized
high-risk prostate cancer undergoing radical prostatectomy.
Detailed description:
PRIMARY OBJECTIVE:
I. To investigate the diagnostic ability of flotufolastat F-18 gallium (18F-rhPSMA-7.3)
PSMA PET/MRI prior to radical prostatectomy in newly diagnosed, high-risk prostate cancer
patients.
SECONDARY OBJECTIVES:
I. Calculating the specificity, positive-predictive value, and negative-predictive value
for the detection of lymph node positivity.
II. Investigating the rates of biochemical recurrence (BCR) as measured by post-operative
prostate specific antigen (PSA) (PSA > 0.20) at pre-defined timepoints in patients.
OUTLINE:
Patients receive 18F-rhPSMA-7.3 intravenously (IV) and undergo PET/MRI up to 30 days
prior to standard of care (SOC) robotic radical prostatectomy with bilateral pelvic lymph
node dissection. Patients also undergo CT or MRI, bone scan and tissue collection during
screening.
Upon completion of study treatment, patients are followed up at 6 weeks, 3 months, 9
months, and 12 months post-surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male subjects with at least age 30 to 85
- 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 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 immunosuppressants
(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 antiandrogens
- Clinical oligometastatic disease with > 3 nodes positive on 18F-rhPSMA-7.3 PSMA
- Previous history of pelvic radiation
- Patients with obesity defined as body mass index (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
Gender:
Male
Minimum age:
30 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Ram A. Pathak, M.D.
Email:
Principal Investigator
Start date:
June 11, 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06389786
https://www.mayo.edu/research/clinical-trials
