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

May 21, 2021 updated by: Michael Graham PhD, MD

68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa Hospitals & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Gallium-68 PSMA-HBED-CC PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months after 68Ga PSMA PET scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 and 12 months after 68Ga PSMA PET scan
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
through 24 hours post-injection of 68Ga PSMA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Graham PhD, MD

Collaborators

University of Iowa
Holden Comprehensive Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201709730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

Available as requested. Data will be archived indefinitely for research purposes.

IPD Sharing Access Criteria

Individuals seeking use of these data should contact the study chair.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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