Clinical Trials /

PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer

NCT03429244

Description:

The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease. A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
  • Official Title: PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0658
  • SECONDARY ID: 1802085219
  • NCT ID: NCT03429244

Conditions

  • Prostate Cancer

Purpose

The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease. A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.

Detailed Description

      This is a prospective, single arm, phase 2 clinical trial. This patient population will have
      low (1 = Gleason 3 + 3) or intermediate risk (2 = 3 + 4; 3 = 4 + 3) prostate cancer. It will
      also enroll those who are at high risk of significant prostate cancer (4Kscore >20%,
      SelectMDx >20%, PSA density >0.15). Patients will be scheduled for magnetic resonance imaging
      (MRI) as part of routine care for either surgical planning or for further biopsy. Following
      the informed consent process, patients who enroll in the study will receive a PSMA positron
      emission tomography (PET) study along with their standard of care (SOC) MRI on an integrated
      PET-MRI. Registration of PET and MRI will be done using software to generate the PET-MRI
      images. Patients receiving SOC MRI guided biopsy will receive additional PET guided biopsies
      as indicated in a single session. The sensitivity and specificity will be evaluated along
      with the ability of the tracer to inform the treatment planning. Patients receiving surgical
      removal of the prostate will have a slice-by-slice whole mount analysis to assess the
      sensitivity and specificity the PSMA PET.

      Primary Objectives Define the accuracy of 68Ga-PSMA-11 PET-CT for detecting the location and
      size of clinically significant prostate cancer lesions in low and intermediate risk disease.

      Secondary Objectives Evaluate how knowledge of the PSMA-PET might inform treatment planning.

      Exploratory Objectives Generate pilot data for future larger clinical trials
    

Trial Arms

NameTypeDescriptionInterventions
Low and intermediate risk prostate cancerExperimental

    Eligibility Criteria

            Inclusion Criteria:
    
              1. ≥ 18 years of age
    
              2. Must provide written informed consent
    
              3. Presence of low or intermediate risk prostate cancer (Gleason grade groups 1-3,
                 PSA<20) on prostate biopsy. Grade-group scoring:
    
                   1. 1 = Gleason 3 + 3
    
                   2. 2 = 3 + 4
    
                   3. 3 = 4 + 3
    
                   4. 4 = 4 + 4
    
                   5. 5 = 4 + 5, 5 + 4, or 5+5
    
              4. Scheduled for prostate biopsy, focal treatment or surgical removal of prostate
    
              5. Willing and able to lie still for approximately 50 minutes in an enclosed space for
                 the standard of care mpMRI
    
            Exclusion Criteria:
    
              1. Participation in another investigational trial involving research exposure to ionizing
                 radiation concurrently or within 30 days.
    
              2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).
    
              3. Significant acute or chronic medical, neurologic, or psychiatric illness in the
                 subject that, in the judgment of the Principal Investigator, could compromise subject
                 safety, limit the subject's ability to complete the study, and/or compromise the
                 objectives of the study.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Diagnostic accuracy of mpMRI
    Time Frame:60 days
    Safety Issue:
    Description:Sextant-based analysis of sensitivity, specificity, and ROC using prostatectomy whole-mount analysis or biopsy pathology

    Secondary Outcome Measures

    Measure:Impact of PSMA PET-CT on treatment plan for surgery - lesions
    Time Frame:60 days
    Safety Issue:
    Description:Number of additional lesions found
    Measure:Impact of PSMA PET-CT on treatment plan for surgery - sextants
    Time Frame:60 days
    Safety Issue:
    Description:Number of additional sextants involved
    Measure:Impact of PSMA PET-CT on treatment plan for surgery - lymph node
    Time Frame:60 days
    Safety Issue:
    Description:Presence or absence of lymph node invasion detected
    Measure:Impact of PSMA PET-CT on treatment plan for surgery - seminal vesicle
    Time Frame:60 days
    Safety Issue:
    Description:Presence or absence of seminal vesicle invasion detected
    Measure:Impact of PSMA PET-CT on treatment plan for biopsy - lesions
    Time Frame:60 days
    Safety Issue:
    Description:Number of additional lesions found
    Measure:Impact of PSMA PET-CT on treatment plan for biopsy - sextants
    Time Frame:60 days
    Safety Issue:
    Description:Number of additional sextants involved
    Measure:Diagnostic accuracy of mpMRI
    Time Frame:60 days
    Safety Issue:
    Description:Llesion-based analysis using prostatectomy whole-mount analysis or biopsy pathology
    Measure:Diagnostic accuracy of PSMA PET-CT
    Time Frame:60 days
    Safety Issue:
    Description:Lesion-based analysis using prostatectomy whole-mount analysis or biopsy pathology

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Indiana University

    Last Updated