Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer

Stage IVA Prostate Cancer AJCC v8 Clinical Trial

Official title:

Safe Omission of Pelvic Lymph Node Dissection (SOuND) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET/CT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389786
• Other study ID #: MC230504
• Secondary ID: NCI-2024-0330623
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Lymphatic Metastasis
• Oligometastatic Prostate Carcinoma
• Prostatic Neoplasms
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8

Intervention

Procedure:
• Bilateral Pelvic Lymph Node Dissection
Undergo bilateral pelvic lymph node dissection
• Biospecimen Collection
Undergo tissue sample collection
• Bone Scan
Undergo bone scan
• Computed Tomography
Undergo CT

Other:
• Electronic Health Record Review
Ancillary studies
• Flotufolastat F-18 Gallium
Given IV

Procedure:
• Laparoscopic Radical Prostatectomy with Robotics
Undergo robotic radical prostatectomy
• Magnetic Resonance Imaging
Undergo MRI or PET/MRI
• Positron Emission Tomography
Undergo PET/MRI

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis	Defined as the presence of lymph node positivity determined on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI. Continuous variables will be summarized as mean (standard deviation) or median (range) while categorical variables will be reported as frequency (percentage). Chi-squared test or Fisher's exact test will be used to compare the proportion of correct results will be compared between rhPSMA-7.3(18F) PET/MRI and the standard care. Will be two-sided with p value < 0.05 considered statistically significant.	Up to 12 months
Secondary	Specificity	Defined as absence of lymph node metastasis on final pathologic analysis compared to findings on preoperative 18F-rhPSMA-7.3 PSMA PET/MRI.; Will be calculated as specificity with 95% confidence intervals. Chi-squared test or Fisher's exact test will be used to compare the proportion of correct results between rhPSMA-7.3(18F) PET/MRI and the standard care.	Up to 12 months
Secondary	Positive/negative predictive value	Defined as findings on 18F-rhPSMA-7.3 prostate specific membrane antigen (PSMA) PET/MRI compared to the presence or absence of lymph node metastasis on final pathologic analysis. Proportion of correct results will be compared between rhPSMA-7.3(18F) PET/MRI and the standard care.	Up to 120 months
Secondary	Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20	Will investigate the impact of PSA as a clinicopathologic variable on lymph node metastasis when used alone and in combination with PSMA PET/MRI using 18F-rhPSMA-7.3.	Up to 12 months
Secondary	Gleason score	Will investigate the impact of Gleason score as a clinicopathologic variable on lymph node metastasis when used alone and in combination with PSMA PET/MRI using 18F-rhPSMA-7.3. Gleason score is a grading system for prostate cancer ranging from 6 (low-grade cancer) to 10 (high-grade cancer).	Up to 12 months
Secondary	Digital rectal examination	Will investigate the impact of digital rectal examination as clinicopathologic variable on lymph node metastasis when used alone and in combination with PSMA PET/MRI using 18F-rhPSMA-7.3.	Up to 12 months
Secondary	Number of patients where management has changed	Defined by the number of patients where PSMA PET/MRI depicts metastatic lesions (e.g. visceral/skeletal) or suspicious lymph nodes outside the true pelvis where standard of care imaging was negative. Proportion of correct results will be compared between rhPSMA-7.3(18F) PET/MRI and the standard care.	Up to 12 months
Secondary	Rates of biochemical recurrent disease (BCR)	BCR rates will be defined as PSA > 0.20 between patients with either negative or positive evidence of PSMA avid disease as indicated on the 18F-rhPSMA-7.3 PSMA PET /MRI and correlated to historical controls. Patients with positive and negative preop imaging results will be compared.	Up to 12 months

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