A Phase 2/3 interventional study of Computed Tomography (CT) scan and 68Ga-PSMA-11 in Prostate Adenocarcinoma, PSA Failure and Recurrent Prostate Carcinoma, sponsored by Andrei Iagaru. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by Andrei Iagaru · Phase 2/3, Interventional, and Diagnostic
The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.
PRIMARY OBJECTIVES:
I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.
Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 61 is close to the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Andrei Iagaru is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation
Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition
Exclusion Criteria:
Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .
Procedure: Computed Tomography (CT) scan · Drug: 68Ga-PSMA-11 · Procedure: Positron Emission Tomography (PET)
PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).
Also known as: Computerized Axial Tomography (CAT), CAT scan, Computed Tomography (CT), Computerized Tomography (CT), CT Scan, tomography
68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.
Also known as: 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-HBED-CC-PSMA, HBED-CC-PSMA, DFKZ-11, Heidelberg compound
PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).
Also known as: Positron Emission Tomography scan (PET-scan), Proton magnetic resonance spectroscopic imaging
Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT
Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.
Time frame: up to 12 months
68Ga-PSMA-11 PET/CT Sensitivity and Specificity
68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.
Time frame: up to 12 months
68Ga-PSMA-11 PET/CT Predictive Value by Region
Positive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.
Time frame: up to 12 months
Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level
Scan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows. * 0.2 to \< 0.5 * 0.5 to \< 1.0 * 1.0 to \< 2.0 * 2.0 to \< 5.0 * ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.
Time frame: up to 12 months
| Milestone | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| Started | 61 |
| Completed | 61 |
| Not completed | 0 |
Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.
| Participants | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| Tumor-positive by 68Ga-PSMA-11 PET/CT | 46 |
| Tumor-negative by 68Ga-PSMA-11 PET/CT | 15 |
68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.
| percentage point estimate | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| Sensitivity | 100.0 (96.3 to 100.0) |
| Specificity | 86.8 (81.8 to 90.9) |
Positive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.
| percentage point estimate | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| Positive predictive value (PPV) | 76.4 (68.0 to 83.5) |
| Negative predictive value (NPV) | 100.0 (98.2 to 100.0) |
Scan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows. * 0.2 to \< 0.5 * 0.5 to \< 1.0 * 1.0 to \< 2.0 * 2.0 to \< 5.0 * ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.
| percentage point estimate | Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.2 to < 0.5 ng/m? | Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL | Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL | Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL | Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL |
|---|---|---|---|---|---|
| Positive predictive value (PPV) | 31.3 (11.0 to 58.7) | 75 (50.9 to 91.3) | 100.0 (39.8 to 100.0) | 82.1 (63.1 to 93.9) | 84.7 (73.0 to 92.8) |
| Negative predictive value (NPV) | 100.0 (96.9 to 100.0) | 100.0 (91.2 to 100.0) | NA (NA to NA) | 100.0 (78.2 to 100.0) | 100.0 (86.8 to 100.0) |
| Sensitivity | 100.0 (47.8 to 100.0) | 100.0 (78.2 to 100.0) | 100.0 (39.8 to 100.0) | 100.0 (85.2 to 100.0) | 100.0 (92.9 to 100.0) |
| Specificity | 91.4 (85.1 to 95.6) | 88.9 (75.9 to 96.3) | NA (NA to NA) | 75.0 (50.9 to 91.3) | 74.3 (56.7 to 87.5) |
Collected over 3 days (per protocol).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic (68Ga-PSMA-11 PET/CT) | 0/61 (0%) | 0/61 (0%) | 0/61 (0%) |
| Age, Categorical(Participants) | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 51 |
| >=65 years | 10 |
| Age, Continuous(years) | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| Mean | 70.5 ± 6.7 |
| Sex: Female, Male(Participants) | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| Female | 0 |
| Male | 61 |
| Ethnicity (NIH/OMB)(Participants) | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 55 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 54 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| United States | 61 |
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Studies of the drug tested here: Gallium 68 PSMA-11
Andrei Iagaru