Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03822845|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.
To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant||Drug: Ga-68 PSMA-HBED-CC PET||Phase 2 Phase 3|
This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated.
The 68Ga PSMA will be tested in men who have biochemical recurrence of prostate cancer after surgery or radiation treatment. Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information, including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team will collect this information for about 1 year after the PSMA scan.
Depending on findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but a surgery or biopsy result does not.
The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Accuracy Assessment of 68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence|
|Estimated Study Start Date :||February 15, 2019|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2028|
Experimental: 68Ga PSMA PET scan
Ga-68 PSMA-HBED-CC PET/CT scan
Drug: Ga-68 PSMA-HBED-CC PET
Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Other Name: Gallium-68 PSMA-HBED-CC PET scan
- Determine sensitivity on a per-patient basis of 68Ga PSMA PET scans for detection of tumor location [CT.gov: ref: NCT03389451 for all comments] [ Time Frame: Up to 12 months after the 68Ga PSMA PET scan ]Sensitivity will be determined on a per-patient basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
- Determine sensitivity on a per-region basis of 68Ga PSMA PET scans for detection of tumor location [ Time Frame: Up to 12 months after the 68Ga PSMA PET scan ]Sensitivity will be determined on a per-region basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
- Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location [ Time Frame: 3 and 12 months after 68Ga PSMA PET scan ]Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
- Determine sensitivity on per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology. [ Time Frame: 3 and 12 months after 68Ga PSMA PET scan ]Sensitivity value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
- Determine detection rates on a per-subject basis of 68Ga PSMA-HBED-CC PET/CT when stratified by PSA value [ Time Frame: 3 and 12 months after 68Ga PSMA PET scan ]Detection rates will be evaluated on a per-subject basis, stratified by PSA values: 0.2 - <0.5, 0.5 - <1.0, 1.0 <2.0, 2.0 - <5.0, 5.0 or greater
- Evaluate adverse events of 68Ga PSMA PET scan [ Time Frame: through 24 hours post-injection of 68Ga PSMA ]Adverse events will be determined through clinical assessment and categorized by CTCAE 4.03
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): NCT03822845
|Contact: Veronica Howsare, AA, MA||(319) firstname.lastname@example.org|
|Contact: Shannon Lehman, BA||(319) email@example.com|
|United States, Iowa|
|The University of Iowa Hospitals & Clinics||Not yet recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Veronica Howsare, AA, MA 319-384-6469 firstname.lastname@example.org|
|Contact: Shannon Lehman, BA (319) 356-2259 email@example.com|
|Principal Investigator: Michael M. Graham, PhD, MD|
|Sub-Investigator: James Brown, MD|
|Sub-Investigator: David Bushnell, MD|
|Sub-Investigator: Lisa Dunnwald, MPH|
|Sub-Investigator: Rohan Garje, MD|
|Sub-Investigator: Paul Gellhaus, MD|
|Sub-Investigator: Veronica Howsare, AA, MA|
|Sub-Investigator: Shannon Lehman, BA|
|Sub-Investigator: Parren McNeely, MD|
|Sub-Investigator: Yusuf Menda, MD|
|Sub-Investigator: Kenneth Nepple, MD|
|Sub-Investigator: Janet Pollard, MD|
|Sub-Investigator: Mark C. Smith, MD|
|Sub-Investigator: John Sunderland, Ph.D.|
|Sub-Investigator: Chad Tracy, MD|
|Sub-Investigator: Yousef Zakharia, MD|
|Sub-Investigator: Jiefu Zheng, MD|
|Study Chair:||Michael M Graham, Ph.D., MD||University of Iowa|