68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04483414|
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : February 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Cancer Metastatic Prostate Cancer Metastatic to Bone||Drug: 68Ga PSMA-11 injection Procedure: Positron Emission Tomography/Computed Tomography||Phase 2|
In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA) after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence.
This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer compared to conventional imaging. In addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Unblinded, single arm imaging study|
|Masking:||None (Open Label)|
|Official Title:||The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy|
|Actual Study Start Date :||March 19, 2021|
|Estimated Primary Completion Date :||September 19, 2023|
|Estimated Study Completion Date :||September 1, 2024|
Experimental: Patients with suspected BCR or metastatic prostate cancer
Patients with suspected BCR or metastatic prostate cancer
Drug: 68Ga PSMA-11 injection
Injection of 68Ga PSMA-11
Procedure: Positron Emission Tomography/Computed Tomography
PET/CT scan after 68Ga PSMA-11 injection
Other Name: PET/CT
- Location of recurrence [ Time Frame: Up to 3 years ]Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
- Residual prostate cancer [ Time Frame: Up to 3 years ]For imaging during or after salvage therapy, existence of residual prostate cancer will be determined for each patient on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
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): NCT04483414
|Contact: Kelli Key, PhD||214-648-8152||Kelli.Key@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Kelli Key, PhD 214-648-8152 Kelli.Key@UTSouthwestern.edu|
|Principal Investigator: Neil Rofsky, MD, MHA|
|Principal Investigator:||Neil Rofsky, MD, MHA||UT Southwestern Medical Center|