Prostate Adenocarcinoma, PSA Failure, Recurrent Prostate Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREComputed Tomography (CT) scan
PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).
DRUG68Ga-PSMA-11
68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.
PROCEDUREPositron Emission Tomography (PET)
PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).
Sponsors
Andrei Iagaru
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathological proven prostate adenocarcinoma * 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 * PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP * Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL) * Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition * A rise of PSA measurement of 2 or more ng/mL over the nadir * Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent) * Able to provide written consent
Exclusion criteria
* Investigational therapy for prostate cancer. * Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan. * Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT | up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 68Ga-PSMA-11 PET/CT Sensitivity and Specificity | up to 12 months | 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. |
| 68Ga-PSMA-11 PET/CT Predictive Value by Region | up to 12 months | 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. |
| Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | up to 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (68Ga-PSMA-11 PET/CT) Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | Diagnostic (68Ga-PSMA-11 PET/CT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 70.5 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 54 Participants |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (68Ga-PSMA-11 PET/CT) | Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT | Tumor-positive by 68Ga-PSMA-11 PET/CT | 46 Participants |
| Diagnostic (68Ga-PSMA-11 PET/CT) | Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT | Tumor-negative by 68Ga-PSMA-11 PET/CT | 15 Participants |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (68Ga-PSMA-11 PET/CT) | 68Ga-PSMA-11 PET/CT Predictive Value by Region | Positive predictive value (PPV) | 76.4 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) | 68Ga-PSMA-11 PET/CT Predictive Value by Region | Negative predictive value (NPV) | 100.0 percentage point estimate |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (68Ga-PSMA-11 PET/CT) | 68Ga-PSMA-11 PET/CT Sensitivity and Specificity | Sensitivity | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) | 68Ga-PSMA-11 PET/CT Sensitivity and Specificity | Specificity | 86.8 percentage point estimate |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (68Ga-PSMA-11 PET/CT) | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Positive predictive value (PPV) | 31.3 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Negative predictive value (NPV) | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Sensitivity | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Specificity | 91.4 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Negative predictive value (NPV) | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Positive predictive value (PPV) | 75 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Specificity | 88.9 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Sensitivity | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Negative predictive value (NPV) | NA percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Sensitivity | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Positive predictive value (PPV) | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Specificity | NA percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Positive predictive value (PPV) | 82.1 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Negative predictive value (NPV) | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Specificity | 75.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Sensitivity | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Specificity | 74.3 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Sensitivity | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Negative predictive value (NPV) | 100.0 percentage point estimate |
| Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL | Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level | Positive predictive value (PPV) | 84.7 percentage point estimate |