This study is about adding PSMA PET (Prostate Specific Membrane Antigen- Positron Emission Tomography) to routine magnetic resonance imaging (MRI) scans to help detect prostate cancer recurrence in men who have undergone focal therapy for prostate cancer. PSMA PET and multiparametric (mpMRI are both imaging tests that help detect prostate cancer in the body.
A PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate. PSMA scans use a specialized radioactive imaging dye that sticks to the proteins that are typically found in prostate cancer cells. This imaging dye helps locate areas of prostate cancer anywhere in the body, both inside and outside prostate.
An mpMRI, or a multiparametric (mp) MRI scan, is also an imaging test that scans and takes detailed pictures of the prostate. Unlike regular MRIs, an mpMRI produces a more detailed image of the prostate. Similar to PET scans, mpMRI scans also use an imaging dye that helps the pictures of the prostate appear clearer on scans.
This study will be funded by Blue Earth Diagnostics, a molecular imaging company based in England.
Subjects must be male (assigned male at birth) and 18 years or older.
Subjects must demonstrate the ability to understand and provide written informed consent.
Subjects must have histologically confirmed prostate cancer ( PCa) Note: Recruitment will be limited to a maximum of 50% of subjects with favorable intermediate-risk prostate cancer (PCa) Note: The histopathologic diagnosis must be obtained via "Prostate Biopsy (PB)", which for the purposes of the present study, is defined as both a systematic 12-core sextant random prostate biopsy and a targeted prostate biopsy. The targeted prostate biopsy can be performed via in-bore multiparemetric (mp) magnetic resonance imaging (MRI) prostate biopsy, cognitive mpMRI/ultrasound fusion prostate biopsy or software mpMRI/ultrasound fusion prostate biopsy. This "PB" must not be obtained greater than 1 year from the date of consent.
Subjects must have chosen to get focal therapy (partial gland ablation) for the treatment of prostate cancer and must be scheduled for partial gland ablation/focal therapy with any energy modality within 6 months following informed consent.
Subject had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa within last 12 months. Subjects who received radiation and/or androgen deprivation therapy for prostate cancer more than 12 months prior to diagnosis of recurrent prostate cancer will be eligible for the trial.
Subjects with locally advanced, nodal or metastatic prostate cancer.
Subjects who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia), permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to gadolinium contrast agent.
If the subject has an uncontrolled or major debilitating inter-current illness.
Single group
PSMA PET/CT scan
RadiationA PSMA PET scan, or prostate-specific membrane antigen positron emission tomography scan, is an imaging test that scans and takes pictures of the prostate. PSMA scans use a specialized radioactive imaging dye that sticks to the proteins that are typically found in prostate cancer cells. This imaging dye helps locate areas of prostate cancer anywhere in the body, both inside and outside prostate.
Determine if adding PSMA-PET scan to MRI will improve cancer detection
Number of identified cancer recurrences identified by PSMA-PET as compared to prostate biopsy
Value of baseline PSMA-PET in combination with MRI imaging for selecting patients for partial gland ablation.
Determine the proportion of patients where baseline PSMA PET changed Focal Therapy selection/treatment plan (deemed ineligible or changed treatment margins or required additional preoperative biopsies).
Value of PSMA-PET in combination with PSA for diagnosing Clinically significant cancer recurrence/residual disease after partial gland ablation
Determine the performance characteristics of PSMA PET alone in detecting CS recurrence (defined as Gleason Score greater than or equal to 2) on prostate biopsy following Focal therapy.
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University of Chicago
Lead sponsor
Blue Earth Diagnositcs
Collaborator
