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68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT02678351
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Tracking Information
First Submitted Date  ICMJE February 2, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date December 24, 2018
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • PSMA-11 PET for detection of regional nodal disease [ Time Frame: Day 1 ]
    68Ga PSMA-11 PET/MRI will be used to detect regional nodal and distant metastases in patients with intermediate and high risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation and pathological analysis. Each patient will be interpreted as positive or negative for the presence of pelvic nodal disease The results will be expressed as range (mean ± SD) of number of lymph nodes identified by PET.
  • Nodal histology evaluation from prostatectomy [ Time Frame: Day 1 ]
    All patients that undergo prostatectomy will be evaluated for the presence of nodal metastasis based on histopathology. This will be reported on a per patient basis as positive or negative. This will be expressed as range (mean ± SD) of number of lymph nodes identified by dissection during surgery plus histopathology
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • Percentage of patients who had true lesions [ Time Frame: Day 1 ]
    Point estimates and 95% confidence intervals will be calculated.
  • Sensitivity of gallium Ga 68-PSMA PET/MRI [ Time Frame: Day 1 ]
    Sites of suspected metastatic disease will be graded on a three-point scale (0=negative, 1=equivocal, 2=positive), with statistical analysis performed with equivocal score of 1 graded as positive or negative on two separate analysis, for a more sensitive or specific visual read, respectively. Point estimates and 95% confidence intervals will be calculated.
  • Specificity of gallium Ga 68-PSMA PET/MRI [ Time Frame: Day 1 ]
    Sites of suspected metastatic disease will be graded on a three-point scale (0=negative, 1=equivocal, 2=positive), with statistical analysis performed with equivocal score of 1 graded as positive or negative on two separate analysis, for a more sensitive or specific visual read, respectively. Point estimates and 95% confidence intervals will be calculated.
Change History Complete list of historical versions of study NCT02678351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • Specificity of gallium Ga 68-PSMA-11 PET/MRI [ Time Frame: Day 1 ]
    Sites of suspected metastatic disease will be graded on a three-point scale (0=negative, 1=equivocal, 2=positive), with statistical analysis performed with equivocal score of 1 graded as positive or negative on two separate analysis, for a more sensitive or specific visual read, respectively. Point estimates and 95% confidence intervals will be calculated.
  • Sensitivity of gallium Ga 68-PSMA-11 PET/MRI [ Time Frame: Day 1 ]
    Sites of suspected metastatic disease will be graded on a three-point scale (0=negative, 1=equivocal, 2=positive), with statistical analysis performed with equivocal score of 1 graded as positive or negative on two separate analysis, for a more sensitive or specific visual read, respectively. Point estimates and 95% confidence intervals will be calculated.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery
Official Title  ICMJE 68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
Brief Summary This phase II/III trial studies gallium 68 Ga (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) in finding tumors in patients with prostate cancer undergoing surgery that tend to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread. Radioactive drugs, such as gallium Ga 68-PSMA, binds to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.
Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate 68Ga-PSMA-11 PET/MRI for detection of regional nodal and distant metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection.

SECONDARY OBJECTIVES:

I. Sensitivity, specificity, positive and negative predictive value of 68Ga-PSMA-11 PET/MRI for the detection of extra pelvic nodal metastases; visceral metastases; and osseous metastases compared to biopsy and imaging follow up.

OUTLINE:

Patients receive 68Ga-PSMA intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

After completion of study, patients are followed up at 24-48 hours.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Stage II Prostate Adenocarcinoma
  • Stage III Prostate Adenocarcinoma
Intervention  ICMJE
  • Drug: gallium Ga 68-PSMA
    Undergo gallium Ga 68-PSMA PET/MRI
  • Procedure: Magnetic Resonance Imaging
    Undergo gallium Ga 68-PSMA PET/MRI
    Other Names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Procedure: Positron Emission Tomography
    Undergo gallium Ga 68-PSMA PET/MRI
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET SCAN
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging
Study Arms  ICMJE Experimental: Diagnostic (68Ga-PSMA PET/MRI)
Patients receive 68Ga-PSMA IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
Interventions:
  • Drug: gallium Ga 68-PSMA
  • Procedure: Magnetic Resonance Imaging
  • Procedure: Positron Emission Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma
  • Planned prostatectomy with lymph node dissection
  • Intermediate to high risk disease (as determined by elevated PSA [PSA>10], T stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors)
  • Able to provide written consent.
  • Karnofsky performance status of ≥ 50 (or ECOG/WHO equivalent)
  • Diagnostic CT or MRI performed within 90 days of the research PET

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
  • Metallic implants (contraindicated for MRI)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Risa Jiron 650-736-1598 rjiron@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678351
Other Study ID Numbers  ICMJE PROS0075
NCI-2016-00092 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-35931 ( Other Identifier: Stanford IRB )
PROS0075 ( Other Identifier: OnCore ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrei Iagaru, Stanford University
Study Sponsor  ICMJE Andrei Iagaru
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Andrei Iagaru Stanford University
PRS Account Stanford University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP