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Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients (PSMA PreRP)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ga-68 labeled PSMA-11 PET
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ga-68 labeled PSMA-11 PET

Arm Description

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.

Outcomes

Primary Outcome Measures

Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
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
Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
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
Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
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
Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
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.

Secondary Outcome Measures

Number of Participants With Grade 3 Treatment-related Adverse Events
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
Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
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.
Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
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.
Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
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.
Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
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.
Sensitivity of PSMA PET for the Detection of Visceral Metastases
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.
Specificity of PSMA PET for the Detection of Visceral Metastases
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.
Positive Predictive Value of PSMA PET Visceral Metastases
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.
Negative Predictive Value of PSMA PET for the Detection of Visceral Metastases
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.
Sensitivity of PSMA PET for the Detection of Osseous Metastases
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.
Specificity of PSMA PET for the Detection of Osseous Metastases
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.
Positive Predictive Value of PSMA PET for the Detection of Osseous Metastases
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.
Negative Predictive Value of PSMA PET for the Detection of Osseous Metastases
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.

Full Information

First Posted
September 26, 2016
Last Updated
November 13, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02919111
Brief Title
Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients
Acronym
PSMA PreRP
Official Title
Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 23, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 high risk disease prior to prostatectomy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ga-68 labeled PSMA-11 PET
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ga-68 labeled PSMA-11 PET
Other Intervention Name(s)
Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC, Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC, Ga-68 labeled HBED-CC PSMA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Description
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
Time Frame
Up to 1 year
Title
Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Description
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
Time Frame
Up to 1 year
Title
Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Description
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
Time Frame
Up to 1 year
Title
Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Number of Participants With Grade 3 Treatment-related Adverse Events
Description
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
Time Frame
Up to 3 days
Title
Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
Description
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.
Time Frame
Up to 1 year
Title
Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
Description
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.
Time Frame
Up to 1 year
Title
Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
Description
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.
Time Frame
Up to 1 year
Title
Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
Description
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.
Time Frame
Up to 1 year
Title
Sensitivity of PSMA PET for the Detection of Visceral Metastases
Description
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.
Time Frame
Up to 1 year
Title
Specificity of PSMA PET for the Detection of Visceral Metastases
Description
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.
Time Frame
Up to 1 year
Title
Positive Predictive Value of PSMA PET Visceral Metastases
Description
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.
Time Frame
Up to 1 year
Title
Negative Predictive Value of PSMA PET for the Detection of Visceral Metastases
Description
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.
Time Frame
Up to 1 year
Title
Sensitivity of PSMA PET for the Detection of Osseous Metastases
Description
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.
Time Frame
Up to 1 year
Title
Specificity of PSMA PET for the Detection of Osseous Metastases
Description
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.
Time Frame
Up to 1 year
Title
Positive Predictive Value of PSMA PET for the Detection of Osseous Metastases
Description
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.
Time Frame
Up to 1 year
Title
Negative Predictive Value of PSMA PET for the Detection of Osseous Metastases
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hope, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34529005
Citation
Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.
Results Reference
derived

Learn more about this trial

Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

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