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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00039 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ga-68 labeled PSMA-11 PET | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 labeled PSMA-11 PET | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation | PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method. | 1 month |
| Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation | PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up | PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI. | 1 month |
| PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up |
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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 Urological Association (AUA) recommendation
Post-radiation therapy -ASTRO-Phoenix consensus definition
Karnofsky performance status of greater than 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:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Hope, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ga-68 Labeled PSMA-11 Positron Emission Tomography (PET) | Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation | PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method. | All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per patient basis. Per patient analyses included an evaluation of positive or negative for presence of localized prostate cancer (PCa). | Posted | Number | 95% Confidence Interval | percentage of times value is true | 1 month |
|
Patients were monitored for adverse events during and for 2 hours after radiotracer administration. Patients were also contacted by phone to assess for the development of delayed adverse events up to 24 hours after radiotracer administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Hope | University of California, San Francisco | (415) 221-4810 | 2264 | thomas.hope@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2016 | Sep 30, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2017 | Oct 23, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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|
PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI. |
| 1 month |
| Sensitivity on a Per-patient Basis | Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method. | 1 month |
| Sensitivity on a Per-region Basis | Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method. | 1 month |
| Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-<0.5; 0.5-<1.0; 1.0-<2.0; 2.0-<5.0, and ≥5.0). | 1 month |
| Inter-reader Agreement Per-region | Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement). | 1 month |
| Percentage of Participants With Change in Clinical Management | Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET. | Up to 1 year |
| Safety Assessment - Heart Rate | Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated. | 1 day |
| Safety Assessment - Blood Pressure | Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated. | 1 day |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Initial therapy | Count of Participants | Participants |
|
|
|
| Primary | Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation | PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method. | All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per region basis. Per region analyses included an evaluation of positive or negative for presence of PCa. Regional analyses included prostate bed, pelvic nodes, extrapelvic non-bone, and bone. | Posted | Number | 95% Confidence Interval | percentage of times value is true | 1 month |
|
|
|
| Secondary | PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up | PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI. | One hundred and twenty-five patients had confirmed imaging at follow-up for this analysis | Posted | Number | 95% Confidence Interval | percentage of times value is true | 1 month |
|
|
|
| Secondary | PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up | PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI. | Two-hundred and forty-nine patients had confirmed regional imaging in follow up for this sample. | Posted | Number | 95% Confidence Interval | percentage of times value is true | 1 month |
|
|
|
| Secondary | Sensitivity on a Per-patient Basis | Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method. | Seventy-nine patients had confirmed patient histopathology validation for this analysis | Posted | Number | 95% Confidence Interval | percentage of sensitivity | 1 month |
|
|
|
| Secondary | Sensitivity on a Per-region Basis | Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method. | Eighty-four patients had confirmed histopathology region validation for this analysis | Posted | Number | 95% Confidence Interval | percentage of sensitivity | 1 month |
|
|
|
| Secondary | Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-<0.5; 0.5-<1.0; 1.0-<2.0; 2.0-<5.0, and ≥5.0). | Portion of patients with 68Ga-PSMA-11 PET positive findings were stratified by PSA range and disease location in accordance with Prostate Magnetic Resonance Imaging Study (PROMIS) | Posted | Number | percentage detected | 1 month |
|
|
|
| Secondary | Inter-reader Agreement Per-region | Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement). | Patients included in the analyses were scanned to include all regions under review | Posted | Number | 95% Confidence Interval | kappa | 1 month |
|
|
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| Secondary | Percentage of Participants With Change in Clinical Management | Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET. | Posted | Number | Percentage of participants | Up to 1 year |
|
|
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| Secondary | Safety Assessment - Heart Rate | Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated. | Posted | Mean | Standard Deviation | beats per minute | 1 day |
|
|
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| Secondary | Safety Assessment - Blood Pressure | Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated. | Pressure exerted by a 1 millimeter vertical column of mercury (Hg) at 0 degree Celsius is defined as (mmHg) | Posted | Mean | Standard Deviation | mmHg | 1 day |
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| 0 |
| 385 |
| 0 |
| 385 |
| 0 |
| 385 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|