Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
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|ClinicalTrials.gov Identifier: NCT03396874|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : February 6, 2020
This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.
To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Adenocarcinoma Prostate Cancer Metastatic Prostate Cancer Recurrent||Drug: 68Ga-PSMA||Phase 2|
This study evaluates Gallium-68 labelled PSMA-11 (also called Gallium-68 labelled PSMA-HBED-CC, or Gallium-68 labelled PSMA N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid), abbreviated here as 68Ga-PSMA. This molecule (or radiotracer) binds to receptors that are often present on prostate cancer cells. Using 68Ga-PSMA together with a positron emission tomography (PET) scanner (with computed tomography, called PET/CT), it is therefore possible to find prostate cancer lesions in the body. The study will test whether 68Ga-PSMA will identify prostate cancer more precisely than normal imaging methods (for example CT, MRI, or bone scan). A more precise identification of the location of the disease is important. Knowing where the disease is located will help to decide on the best course of action to treat the disease.
Men who have elevated tumor markers of prostate cancer are eligible for this study. Participants undergo a 68Ga-PSMA PET/CT scan before further treatment. Based on clinical information, including any prior imaging and biopsy/surgery information and follow-up information, we will determine whether 68Ga-PSMA PET/CT imaging was more accurate than the standard imaging. The study team will collect this information for up to 1 year after the 68Ga-PSMA PET/CT scan.
The results of the 68Ga-PSMA PET/CT scan will be shared with the participating patients. Also, results will be entered into the participant's medical record and shared with the treating physicians.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence|
|Actual Study Start Date :||February 9, 2018|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2022|
PET/CT imaging with 68Ga-PSMA:
68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
- Positive predictive value (PPV) of 68Ga PSMA PET/CT for detection of prostate cancer on a per-patient basis. [ Time Frame: Up to 12 months after 68Ga-PSMA scan ]The positive predictive value (PPV) of 68Ga PSMA PET/CT for detecting prostate cancer on a per-patient basis will be confirmed by histopathology.
- Sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA PET/CT for detection of tumor location. [ Time Frame: Up to 12 months after 68Ga-PSMA scan ]The sensitivity and PPV of 68Ga-PSMA PET/CT will be determined on a per-patient and per-region-basis for the detection of tumor location. Confirmation is obtained by conventional imaging, clinical follow-up, and histopathology/biopsy where available.
- Adverse events of 68Ga-PSMA administration [ Time Frame: 24 hours post injection ]Adverse events will be determined through clinical assessment and categorized by CTCAE 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396874
|Contact: James Poolfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: James Pool 734-615-7391 email@example.com|
|Principal Investigator:||Morand R Piert, M.D.||University of Michigan|