Prostate Cancer
Conditions
Brief summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Interventions
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Sponsors
Thomas Hope
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
* Histopathologically proven prostate adenocarcinoma. * Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). * Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy * PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP. * Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy * Nadir + greater than or equal to 2 ng/mL rise in PSA * Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent). * Age \>= 18. * Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
* Unable to lie flat, still or tolerate a PET scan. * Concomitant investigational therapy. * Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. * Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | 1 Day | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. |
| True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | 1 Day | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. |
| True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | 1 Day | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. |
| True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | 1 day | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only | 1 Day | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. |
| True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only | 1 Day | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. |
| True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only | 1 Day | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. |
| True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only | 1 Day | The true positive rate or detection rate is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. |
| PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only | 1 Day | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy |
| PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only | 1 Day | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the visceral tissue as confirmed by by histopathology/biopsy |
| PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only | 1 Day | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the bone tissue as confirmed by by histopathology/biopsy |
| Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | 1 Day | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. |
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | 1 Day | Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- \<0.5, 0.5 - \<1.0, 1.0 - \<2.0, 2.0 - \<5.0, \>=5.0) will be summarized in tabular format for participants with PSMA positive disease, independent of pathology, imaging or clinical follow-up. |
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment | 1 Day | Detection rates (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior cancer treatment (Prostatectomy, Radiation, or Prostatectomy plus Radiation) will be summarized in tabular format. |
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) | 1 Day | Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior use of ADT as a cancer treatment (Prior treatment with ADT, No prior treatment with ADT) will be summarized in tabular format. |
| Percent of Participants With a Change in Clinical Management | Up to 6 months | Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) was measured using Pre-PET (Q1), post-PET (Q2), and post-treatment (Q3) questionnaires sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Percentage of participants with a change in clinical management will be reported using descriptive statistics based on qualitative physician responses from the change in management surveys. |
| Rate of Inter-reader Reproducibility for Positivity | 1 Day | Inter-reader reproducibility for positivity at the patient level will be reported using the Fleiss' Kappa test for multiple readers |
| Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events | Up to 30 days | All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0. The Investigator will assign attribution of the possible association of the event with use of the investigational drug. |
| PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only | 1 Day | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy |
| PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | 1 Day | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in visceral tissue as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. |
| PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | 1 Day | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer metastasized in the bone as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. |
| PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | 1 Day | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ga-68 Labeled PSMA-11 PET PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. | 346 |
| Total | 346 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Images for these participants not viable | 52 |
Baseline characteristics
| Characteristic | Ga-68 Labeled PSMA-11 PET |
|---|---|
| Age, Customized 40-49 years old | 2 Participants |
| Age, Customized 50-59 years old | 22 Participants |
| Age, Customized 60-69 years old | 125 Participants |
| Age, Customized 70-79 years old | 157 Participants |
| Age, Customized 80-89 years old | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 323 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants |
| Race (NIH/OMB) White | 276 Participants |
| Region of Enrollment United States | 346 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 346 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 346 |
| other Total, other adverse events | 0 / 346 |
| serious Total, serious adverse events | 0 / 346 |
Outcome results
Primary
True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
Time frame: 1 Day
Population: Data on clinical and conventional imaging follow-up not collected
Primary
True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
Time frame: 1 Day
Population: Data on clinical and conventional imaging follow-up not collected
Primary
True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
Time frame: 1 day
Population: Data on clinical and conventional imaging follow-up not collected
Primary
True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.
Time frame: 1 Day
Population: Data on clinical and conventional imaging follow-up not collected
Secondary
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment
Detection rates (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior cancer treatment (Prostatectomy, Radiation, or Prostatectomy plus Radiation) will be summarized in tabular format.
Time frame: 1 Day
Population: Prior cancer treatment for only 287 evaluable participants was collected. The number analyzed per row represents the number of participants in each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment | Prostatectomy only | 0.93 proportion of participants |
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment | Radiation therapy only | 0.65 proportion of participants |
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment | Prostatectomy and salvage radiation therapy | 0.84 proportion of participants |
Secondary
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT)
Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior use of ADT as a cancer treatment (Prior treatment with ADT, No prior treatment with ADT) will be summarized in tabular format.
Time frame: 1 Day
Population: Prior ADT treatment for only 272 evaluable participants was collected. The number analyzed per row represents the number of participants in each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) | Prior treatment with ADT | 0.8 proportion of participants |
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) | No prior treatment with ADT | 0.8 proportion of participants |
Secondary
Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- \<0.5, 0.5 - \<1.0, 1.0 - \<2.0, 2.0 - \<5.0, \>=5.0) will be summarized in tabular format for participants with PSMA positive disease, independent of pathology, imaging or clinical follow-up.
Time frame: 1 Day
Population: The number analyzed per row represents the number of participants in each category
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | PSA = < 0.5 | 0.53 proportion of participants |
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | PSA = 0.5 - <1.0 | 0.68 proportion of participants |
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | PSA = 1.0 - <2.0 | 0.68 proportion of participants |
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | PSA = 2.0 - <5.0 | 0.93 proportion of participants |
| Ga-68 Labeled PSMA-11 PET | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | PSA >= 5.0 | 0.94 proportion of participants |
Secondary
Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events
All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0. The Investigator will assign attribution of the possible association of the event with use of the investigational drug.
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events | 0 Participants |
Secondary
Percent of Participants With a Change in Clinical Management
Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) was measured using Pre-PET (Q1), post-PET (Q2), and post-treatment (Q3) questionnaires sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Percentage of participants with a change in clinical management will be reported using descriptive statistics based on qualitative physician responses from the change in management surveys.
Time frame: Up to 6 months
Population: Data on change in clinical management not collected for this sample
Secondary
Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.
Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.
Time frame: 1 Day
Population: Data on clinical and conventional imaging follow-up not collected
Secondary
PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.
Positive predictive value is the probability that participants with a positive reading truly have prostate cancer metastasized in the bone as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.
Time frame: 1 Day
Population: Data on clinical and conventional imaging follow-up not collected
Secondary
PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only
Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the bone tissue as confirmed by by histopathology/biopsy
Time frame: 1 Day
Population: Only 2 participants had adequate histology/biopsy data for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only | 1.00 proportion |
Secondary
PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only
Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy
Time frame: 1 Day
Population: Only 7 participants had adequate histology/biopsy data for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only | 0.5 proportion |
Secondary
PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.
Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.
Time frame: 1 Day
Population: Data on clinical and conventional imaging follow-up not collected
Secondary
PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only
Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy
Time frame: 1 Day
Population: Only 30 participants had adequate histology/biopsy data for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only | 0.92 proportion |
Secondary
PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.
Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in visceral tissue as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up.
Time frame: 1 Day
Population: Data on clinical and conventional imaging follow-up not collected
Secondary
PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only
Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the visceral tissue as confirmed by by histopathology/biopsy
Time frame: 1 Day
Population: Only 9 participants had adequate histology/biopsy data for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only | 0.86 proportion |
Secondary
Rate of Inter-reader Reproducibility for Positivity
Inter-reader reproducibility for positivity at the patient level will be reported using the Fleiss' Kappa test for multiple readers
Time frame: 1 Day
Population: Inter-reader reproducibility data not collected
Secondary
True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.
Time frame: 1 Day
Population: Only 2 participants had adequate histology/biopsy data for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only | 1.00 proportion of participants |
Secondary
True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.
Time frame: 1 Day
Population: Only 7 participants had adequate histology/biopsy data for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only | 0.40 proportion of participants |
Secondary
True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only
The true positive rate or detection rate is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.
Time frame: 1 Day
Population: Only 30 participants had adequate histology/biopsy data for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only | 0.88 proportion of participants |
Secondary
True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only
The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only.
Time frame: 1 Day
Population: Only 9 participants had adequate histology/biopsy data for this analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ga-68 Labeled PSMA-11 PET | True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only | 0.86 proportion of participants |