68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04050215|
Recruitment Status : Completed
First Posted : August 8, 2019
Last Update Posted : September 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Biochemically Recurrent Prostate Carcinoma Metastatic Prostate Carcinoma Prostate Adenocarcinoma Prostate Carcinoma PSA Level Greater Than Fifty PSA Progression Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8||Procedure: Computed Tomography Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Positron Emission Tomography Other: Questionnaire Administration||Phase 2|
I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.
Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
After completion of study, patients are followed up within 3-12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||937 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of 68GA-PSMA-11 PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer|
|Actual Study Start Date :||April 2, 2018|
|Actual Primary Completion Date :||September 27, 2021|
|Actual Study Completion Date :||September 27, 2021|
Experimental: Diagnostic (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
Procedure: Computed Tomography
Drug: Gallium Ga 68-labeled PSMA-11
Procedure: Positron Emission Tomography
Other: Questionnaire Administration
- Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) [ Time Frame: Up to 3-6 months after completion of imaging ]A separate analysis of initial versus subsequent management will be performed. Will be evaluated using descriptive statistics for both the treatment modality analysis and the disease stage based management analysis. Questionnaires will be collected to determine the intended patient management before and intended management changes after PET/CT, and to determine whether intended management changes were implemented. The outcome measure is the rate of change (%) as assessed by the questionnaires before and after PET.
- Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for biochemical progression-free survival (PFS) [ Time Frame: From inclusion to date until PSA progression or death (whichever occurs first), assessed up to 12 months ]
- Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for radiographic PFS [ Time Frame: From inclusion to date until first site of disease is found to progress or death (whichever occurs first), assessed up to 12 months ]Nodal and visceral disease will be evaluated on cross-sectional imaging using Response Evaluation Criteria in Solid Tumors 1.1/Prostate Cancer Working Group 3 (PCWG3) criteria. Bone metastases will be evaluated using bone scintigraphy and new lesions have to be confirmed on a second scan (2+2 rule) using PCWG3 criteria.
- Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for overall survival [ Time Frame: From inclusion to date of death, assessed up to 12 months ]
- Positive predictive value (PPV) on a per-patient and per-region basis of 68Ga-PSMA-11 PET for detection of tumor location [ Time Frame: Up to 12 months ]Confirmed by histopathology/biopsy or follow-up assessed separately for initial staging and restaging. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method. PPV will be reported for each of the three blinded readers independently. Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate-specific antigen (PSA) value will be summarized in tabular format and compared between PSA strata using chi-square analysis. Detection rate is defined as number of patients with PSMA positive disease, independent of pathology, imaging or clinical follow-up. A detection rate will be reported for each reader independently stratified by PSA.
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): NCT04050215
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Jeremie Calais||UCLA / Jonsson Comprehensive Cancer Center|