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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

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.

Condition or disease Intervention/treatment Phase
Stage II Prostate Adenocarcinoma Stage III Prostate Adenocarcinoma Drug: gallium Ga 68-PSMA Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Diagnostic (68Ga-PSMA PET/MRI)
Patients receive 68Ga-PSMA IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
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




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678351


Contacts
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Contact: Risa Jiron 650-736-1598 rjiron@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Risa Jiron    650-736-1598    rjiron@stanford.edu   
Principal Investigator: Andrei Iagaru         
Sponsors and Collaborators
Andrei Iagaru
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Andrei Iagaru Stanford University

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Responsible Party: Andrei Iagaru, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT02678351     History of Changes
Other Study ID Numbers: PROS0075
NCI-2016-00092 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-35931 ( Other Identifier: Stanford IRB )
PROS0075 ( Other Identifier: OnCore ID )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type