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

Sponsor
Michael Graham PhD, MD (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03822845
Collaborator
(none)
240
1
1
118
2

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
N/A
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 :
Mar 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

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 Names:
  • Gallium-68 PSMA-HBED-CC PET scan
  • Outcome Measures

    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] [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 [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 [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. [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 [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 [through 24 hours post-injection of 68Ga PSMA]

      Adverse events will be determined through clinical assessment and categorized by CTCAE 4.03

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Michael Graham PhD, MD

    Investigators

    • Study Chair: Michael M Graham, Ph.D., MD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Michael Graham PhD, MD, Professor, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT03822845
    Other Study ID Numbers:
    • 201810754
    First Posted:
    Jan 30, 2019
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael Graham PhD, MD, Professor, University of Iowa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 25, 2021