68Ga PSMA in Preprostatectomy Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03388346|
Recruitment Status : Enrolling by invitation
First Posted : January 2, 2018
Last Update Posted : February 28, 2018
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|
|Prostate Cancer Prostatic Neoplasm Prostatic Neoplasms, Castration-Resistant Prostatic Neoplasm of Uncertain Behavior||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.
Men who are scheduled to undergo a prostatectomy are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before the prostatectomy. Information from the prostatectomy, including any MRI, CT, or ultrasound imaging, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging.
Depending on the prostatectomy 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 the surgery/biopsy results do 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 :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68Ga PSMA-HBED-CC in Intermediate to High-Risk Preprostatectomy Patients|
|Actual Study Start Date :||February 16, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: 68Ga PSMA PET scan
Ga-68 PSMA-HBED-CC PET
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
- Diagnostic accuracy of 68Ga PSMA PET scans for detection of regional pelvic nodal metastases [ Time Frame: Within 3 months of prostectomy ]Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan for regional pelvic nodal metastases using pathological results from the prostatecomy
- Diagnostic accuracy of 68Ga PSMA PET scans for detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases. [ Time Frame: at 3 and 12 months post-prostatecomy ]Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan using biopsy results, imaging, and clinical follow-up information.
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): NCT03388346
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Study Chair:||Michael Graham, MD, PhD||University of Iowa|