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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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Fluorides

Protective Agents

Patients receive fluorine F 18 DCFPyL IV and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo TRUS guided prostate biopsy per standard of care.

Fluorine F 18 DCFPyL

Gadobenate Dimeglumine

Gadobutrol

Magnetic Resonance Imaging

Multiparametric Magnetic Resonance Imaging

Positron Emission Tomography

Transrectal Ultrasonography Guided Biopsy

Study Coordinator

Edward M. Schaeffer

Edward M Schaeffer, MD/PhD

This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL. 18F-DCFPyl is a radioactive injectable imaging agent made of a prostate specific membrane antigen (PSMA) that attaches to tumor cells, which makes it useful for the diagnosis of prostate cancer. A PET scan is an imaging tool that may help find the location of cancer, by using a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. A mp-MRI is used to help determine the extent of a patient's cancer. A MRI scan uses strong magnets and computers to create detailed images of the soft tissue in the body. This trial aims to compare PET scans to prostate specific mp-MRI to evaluate prostate cancer severity in men with a positive screen for prostate cancer.

PRIMARY OBJECTIVE:

I. Compare the fluorine F 18 DCFPyL (18-F-DCFPyL) PET to multiparametric magnetic resonance imaging (mpMRI) for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (International Society of Urological Pathology \[ISUP\] group \>= 2).

SECONDARY OBJECTIVES:

I. Compare the combined 18-F-DCFPyL PET and mpMRI to mpMRI alone for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (ISUP group \>= 2).

II. Estimate the sensitivities and specificities of combined 18-F-DCFPyL PET/mpMRI, mpMRI alone, 18-F-DCFPyL PET alone, and prostate health index (PHI) alone for the diagnosis of clinically significant prostate cancer.

III. Estimate the accuracy of PET alone for the diagnosis of clinically significant prostate cancer in biopsy naïve men as defined by Gleason score \>= 3+4 (ISUP group \>=2).

IV. Compare the accuracy of PET to prostate health index (PHI) for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (ISUP group \>= 2).

OUTLINE:

Patients receive fluorine F 18 DCFPyL intravenously (IV) and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo transrectal ultrasound (TRUS) guided prostate biopsy per standard of care.

After completion of study intervention, patients are followed up within 24 hours, and then at 30 days.

PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer

Phase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate Cancer

Will be compared to multiparametric magnetic resonance imaging (mpMRI) for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (International Society of Urological Pathology \[ISUP\] group \>=2).

Will be estimated and compared to mpMRI alone for the diagnosis of clinically significant prostate cancer in biopsy naive men as defined by Gleason score \>= 3+4 (ISUP group \>= 2).

National Cancer Institute (NCI)

Northwestern University

Anti-Infective Agents

Anticoagulants

Bone Density Conservation Agents

Amino Acids

Gallium 68 PSMA-11

Carbamide Peroxide

Edetic Acid

Pentetic Acid

Chelating Agents

Calcium

Calcium, Dietary

Radiopharmaceuticals

Lysine

SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 IV and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.

IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.

Biopsy of Prostate

Gallium Ga 68 Gozetotide

Wesley Armstrong

Stephanie Lira

Ethan Lam

Jeremie Calais

This early phase I trial studies how well an image-guided prostate biopsy using the imaging agent 68Ga-prostate-specific membrane antigen (PSMA)-11 with a positron emission tomography/computed tomography (PET/CT) scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy. PSMA is a protein that is found on the surface of prostate cancer cells. 68Ga-PSMA-11 is made up of a substance that binds to PSMA on tumor cells, linked with a radioactive substance that can then be seen on imaging scans such as PET/CT. 68Ga-PSMA-11 PET/CT-guided biopsy may help improve the detection rate of prostate cancer. This may help reduce over-diagnosis and over-treatment in men with low-risk prostate cancer and under-treatment in men with high-risk prostate cancer.

PRIMARY OBJECTIVE:

I. To assess the detection rate of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal gallium Ga 68 gozetotide (68Ga-PSMA-11) uptake within the prostate.

OUTLINE:

SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.

IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care transrectal ultrasonography guided biopsy (TRUS).

Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy

Evaluation of 68Ga-PSMA-11 PET Guided Prostate Biopsy in Men With Suspicion of Clinically Significant Prostate Cancer and Prior Negative/Inconclusive Biopsy: A Prospective Exploratory Study

Defined as the percentage of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal 68Ga-PSMA-11 uptake within the prostate

Jonsson Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer	NCT04910425	Prostate Carcin...	Fluorine F 18 D... Gadobenate Dime... Gadobutrol Magnetic Resona... Multiparametric... Positron Emissi... Transrectal Ult...	18 Years -	Northwestern University
Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy	NCT05160597	Prostate Carcin...	Biopsy of Prost... Gallium Ga 68 G... Transrectal Ult...	18 Years - 90 Years	Jonsson Comprehensive Cancer Center
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer	NCT04910425	Prostate Carcin...	Fluorine F 18 D... Gadobenate Dime... Gadobutrol Magnetic Resona... Multiparametric... Positron Emissi... Transrectal Ult...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for transrectal ultrasonography guided biopsy