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Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03822845
Recruitment Status : Enrolling by invitation
First Posted : January 30, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Graham, University of Iowa

Brief Summary:

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.

To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Drug: Ga-68 PSMA-HBED-CC PET Phase 2 Phase 3

Detailed Description:

This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated.

The 68Ga PSMA will be tested in men who have biochemical recurrence of prostate cancer after surgery or radiation treatment. Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information, including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team will collect this information for about 1 year after the PSMA scan.

Depending on findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but a surgery or biopsy result does not.

The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Accuracy Assessment of 68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: 68Ga PSMA PET scan
Ga-68 PSMA-HBED-CC PET/CT scan
Drug: Ga-68 PSMA-HBED-CC PET
Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Other Name: Gallium-68 PSMA-HBED-CC PET scan




Primary Outcome Measures :
  1. Determine sensitivity on a per-patient basis of 68Ga PSMA PET scans for detection of tumor location [CT.gov: ref: NCT03389451 for all comments] [ Time Frame: Up to 12 months after the 68Ga PSMA PET scan ]
    Sensitivity will be determined on a per-patient basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

  2. Determine sensitivity on a per-region basis of 68Ga PSMA PET scans for detection of tumor location [ Time Frame: Up to 12 months after the 68Ga PSMA PET scan ]
    Sensitivity will be determined on a per-region basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.


Secondary Outcome Measures :
  1. Determine positive predictive value on a per-subject and per-region basis of 68Ga PSMA PET scans for detection of tumor location [ Time Frame: 3 and 12 months after 68Ga PSMA PET scan ]
    Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

  2. Determine sensitivity on per-subject and per-region basis of 68Ga PSMA-HBED-CC PET/CT for detecting tumor location, confirming with histopathology. [ Time Frame: 3 and 12 months after 68Ga PSMA PET scan ]
    Sensitivity value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

  3. Determine detection rates on a per-subject basis of 68Ga PSMA-HBED-CC PET/CT when stratified by PSA value [ Time Frame: 3 and 12 months after 68Ga PSMA PET scan ]
    Detection rates will be evaluated on a per-subject basis, stratified by PSA values: 0.2 - <0.5, 0.5 - <1.0, 1.0 <2.0, 2.0 - <5.0, 5.0 or greater

  4. Evaluate adverse events of 68Ga PSMA PET scan [ Time Frame: through 24 hours post-injection of 68Ga PSMA ]
    Adverse events will be determined through clinical assessment and categorized by CTCAE 4.03



Information from the National Library of Medicine

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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:

  • Ability to understand and willingness to provide informed consent.
  • Pathologically proven prostate adenocarcinoma.
  • Rising PSA after definitive therapy with a prostatectomy or radiation therapy (external beam radiation therapy or brachytherapy).
  • If post-radical prostatectomy, a PSA level of > 0.2 ng/mL measured more than 6 weeks post-operatively with a second confirmatory persistent PSA > 0.2 ng/mL.
  • If post-radiation therapy, a PSA level that is equal to, or greater than, a 2 mg/mL rise above the lowest PSA value ('nadir').
  • A PSA level result within the last 2 months meeting criteria above.
  • Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations).
  • No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion).
  • Karnofsky performance status greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months.

Exclusion Criteria:

  • Cannot receive furosemide.
  • History of Stevens-Johnson syndrome.
  • History or diagnosis of Paget's disease.
  • Malignancy other than current disease under study.
  • Allergy to sulfa or sulfa-containing medications.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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): NCT03822845


Locations
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United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Michael Graham
Investigators
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Study Chair: Michael M Graham, Ph.D., MD University of Iowa

Publications:

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Responsible Party: Michael Graham, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03822845     History of Changes
Other Study ID Numbers: 201810754
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Codified data will be archived and stored in an imaging repository with limited metadata for analysis. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Reviewed upon request; may not be immediately available depending upon accrual and study's completion status. Data will be archived for research purposes.
Access Criteria: Individuals seeking use of these data should contact the study chair. A contract may be necessary for data sharing.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Graham, University of Iowa:
Nuclear scans
PET imaging
prostate cancer

Additional relevant MeSH terms:
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Neoplasms
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Recurrence
Disease Attributes
Pathologic Processes
Genital Diseases, Male
N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid
Edetic Acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents