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68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03389451
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2018
Last Update Posted : March 1, 2018
Sponsor:
Collaborators:
University of Iowa
Holden Comprehensive Cancer Center
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 Cancer Recurrent Prostatic Cancer Metastatic 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 have biochemical recurrence of prostate cancer are invited to test 68Ga PSMA. 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 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 PET in Patients With Biochemical Recurrence
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 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 PET
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-subject basis of 68Ga PSMA PET scans for detection of tumor location [ Time Frame: Up to 12 months after 68Ga PSMA PET scan ]
    Sensitivity 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.


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. 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



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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:

  • Pathologically proven prostate adenocarcinoma
  • Rising PSA after definitive therapy with prostatecomy or radiation therapy (external beam or brachytherapy)
  • If post-radical prostatecomy, PSA > 0.2 ng/mL measured > 6 weeks post-operative and confirmed persistent PSA > 0.2 ng/mL (AUA recommendation for biochemical recurrence)
  • If post-radiation therapy, PSA that is ≥ 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence)
  • 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 (KPS) ≥ 50 (ECOG/WHO of 0, 1, or 2)
  • Ability to understand and willingness to provide informed consent

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): NCT03389451


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

Publications:

Responsible Party: Michael Graham, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03389451     History of Changes
Other Study ID Numbers: 201709730
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 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.

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:
68Ga-PSMA-11
(68Ga)Glu-urea-Lys(Ahx)-HBED-CC
68Ga PSMA-HBED-CC

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasms
Recurrence
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes
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