- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02919111
Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients (PSMA PreRP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis.
This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring Ga-68-PSMA-11 to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94107
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biopsy proven prostate adenocarcinoma.
- Planned prostatectomy with lymph node dissection.
- Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).
- Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
- 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:
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
- Including focal ablation techniques (HiFu).
- Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Time Frame: Up to 1 year
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Sensitivity is defined as the ratio of the proportion of the patients who have the condition of interest and whose test results are positive over the number who have the disease.
Patients who have a positive node on imaging and on pathology will be considered a true-positive.
Patients who have no nodes on imaging and pathology will be considered true-negatives.
Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.
Follow-up scans for up to one year can be used in analysis
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Up to 1 year
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Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Time Frame: Up to 1 year
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Specificity is defined as the number of non-diseased participants correctly classified divided by all non-diseased individuals.
Patients who have a positive node on imaging and on pathology will be considered a true-positive.
Patients who have no nodes on imaging and pathology will be considered true-negatives.
Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.
Follow-up scans for up to one year can be used in analysis
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Up to 1 year
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Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Time Frame: Up to 1 year
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PPV is the proportion of patients with positive test who actually have the disease.
Patients who have a positive node on imaging and on pathology will be considered a true-positive.
Patients who have no nodes on imaging and pathology will be considered true-negatives.
Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.
Follow-up scans for up to one year can be used in analysis
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Up to 1 year
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Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Time Frame: Up to 1 year
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NPV is the ratio of participants truly diagnosed as negative to all those who had negative test results.
Patients who have a positive node on imaging and on pathology will be considered a true-positive.
Patients who have no nodes on imaging and pathology will be considered true- negatives.
Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives.
Follow-up scans for obtained up to one year after study scan be used in analysis.
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Up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Grade 3 Treatment-related Adverse Events
Time Frame: Up to 3 days
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All grade 3 and above adverse events were recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
The Investigator assigns grade, attribution of the possible association of the event with use of the investigational drug.
The safety parameters include spontaneous reports of adverse events reported to the investigator by patients
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Up to 3 days
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Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
Time Frame: Up to 1 year
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Gallium 68 labeled PSMA-11 (68Ga-PSMA-11) positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size.
Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of Prostate-specific antigen (PSA) by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives.
If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives.
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Up to 1 year
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Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
Time Frame: Up to 1 year
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68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size.
Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives.
If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives.
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Up to 1 year
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Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
Time Frame: Up to 1 year
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68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size.
Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives.
If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives.
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Up to 1 year
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Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
Time Frame: Up to 1 year
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68Ga-PSMA-11 positive lymph nodes will be considered for detection of extra-pelvic nodal metastases and assessed by change in size.
Participants who if on follow-up imaging within 3-12 months, have lymph nodes which decrease by more than 30% or increase by more than 20% in short axis diameter (with a minimum of 3 mm in change in size) or with solitary lymph node regions show a decrease of PSA by >50% after targeted treatment and the lymph nodes do not change in size (less than 30% decrease or less than 20% increase in short axis diameter) will be counted as true positives.
If on follow-up imaging, sites of initial 68Ga-PSMA-11 positive lymph node lesions < 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive lymph node lesions that do not meet criteria for above false positive or true positive will be counted as false positives.
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Up to 1 year
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Sensitivity of PSMA PET for the Detection of Visceral Metastases
Time Frame: Up to 1 year
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Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size.
68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings.
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Up to 1 year
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Specificity of PSMA PET for the Detection of Visceral Metastases
Time Frame: Up to 1 year
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Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size.
68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings.
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Up to 1 year
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Positive Predictive Value of PSMA PET Visceral Metastases
Time Frame: Up to 1 year
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Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size.
68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings.
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Up to 1 year
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Negative Predictive Value of PSMA PET for the Detection of Visceral Metastases
Time Frame: Up to 1 year
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Visceral lesions (non-lymph node soft tissue or organ) will be assessed by change in size.
68Ga-PSMA-11 positive visceral lesions will be considered True positive if on follow-up imaging within 3-12 months, visceral lesions seen on imaging decrease by 30% (for patients undergoing systemic treatment of focal therapy at this site) or increase by 20% in largest diameter or if participants with solitary visceral metastasis show a decrease of PSA by greater than 50% after targeted treatment and lesions do not change in size (less than 30% decrease or 20% increase in largest diameter) and False positive if on follow-up imaging within 3-12 months, sites of initial 68Ga-PSMA-11 positive visceral lesions seen on CT or MRI decrease by more than 30% without systemic therapy or focal therapy at this site or if 68Ga-PSMA-11 positive visceral lesions do not meet the criteria for above false positive or true positive findings.
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Up to 1 year
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Sensitivity of PSMA PET for the Detection of Osseous Metastases
Time Frame: Up to 1 year
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68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings.
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Up to 1 year
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Specificity of PSMA PET for the Detection of Osseous Metastases
Time Frame: Up to 1 year
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68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings.
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Up to 1 year
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Positive Predictive Value of PSMA PET for the Detection of Osseous Metastases
Time Frame: Up to 1 year
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68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings.
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Up to 1 year
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Negative Predictive Value of PSMA PET for the Detection of Osseous Metastases
Time Frame: Up to 1 year
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68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings.
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Up to 1 year
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16559
- NCI-2018-00038 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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