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68Ga PSMA in Preprostatectomy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03388346
Recruitment Status : Enrolling by invitation
First Posted : January 2, 2018
Last Update Posted : December 18, 2018
Holden Comprehensive Cancer Center
University of Iowa
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
Prostate Cancer Prostatic Neoplasm Prostatic Neoplasms, Castration-Resistant Prostatic Neoplasm of Uncertain Behavior 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.

Men who are scheduled to undergo a prostatectomy are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before the prostatectomy. Information from the prostatectomy, including any MRI, CT, or ultrasound imaging, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging.

Depending on the prostatectomy 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 the surgery/biopsy results do 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 : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga PSMA-HBED-CC in Intermediate to High-Risk Preprostatectomy Patients
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: 68Ga PSMA PET scan
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. Diagnostic accuracy of 68Ga PSMA PET scans for detection of regional pelvic nodal metastases [ Time Frame: Within 3 months of prostectomy ]
    Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan for regional pelvic nodal metastases using pathological results from the prostatecomy

Secondary Outcome Measures :
  1. Diagnostic accuracy of 68Ga PSMA PET scans for detection of extra-pelvic nodal metastases, visceral metastases, and osseous metastases. [ Time Frame: at 3 and 12 months post-prostatecomy ]
    Sensitivity, specificity, positive, and negative predictive value of 68Ga PSMA PET scan using biopsy results, imaging, and clinical follow-up information.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Biopsy-proven prostate adenocarcinoma
  • Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater
  • A PSA level resulted within the past 2 months
  • Planned prostatectomy with lymph node dissection
  • Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months
  • Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)
  • Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations
  • Ability to understand and the willingness to provide informed consent.

Exclusion Criteria:

  • Cannot receive furosemide
  • Allergy to sulfa or sulfa-containing medications
  • History of Stevens-Johnson syndrome
  • Known Paget's disease
  • 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 identifier (NCT number): NCT03388346

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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Michael Graham
Holden Comprehensive Cancer Center
University of Iowa
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Study Chair: Michael Graham, MD, PhD University of Iowa


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Responsible Party: Michael Graham, Professor, University of Iowa Identifier: NCT03388346     History of Changes
Other Study ID Numbers: 201708824
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
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. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Available as requested. Data will be archived indefinitely for research purposes.
Access Criteria: Individuals seeking use of these data should contact the study chair.

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