Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

October 10, 2023 updated by: Morand Piert, MD, University of Michigan

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.

To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluates Gallium-68 labelled PSMA-11 (also called Gallium-68 labelled PSMA-HBED-CC, or Gallium-68 labelled PSMA N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid), abbreviated here as 68Ga-PSMA. This molecule (or radiotracer) binds to receptors that are often present on prostate cancer cells. Using 68Ga-PSMA together with a positron emission tomography (PET) scanner (with computed tomography, called PET/CT), it is therefore possible to find prostate cancer lesions in the body. The study will test whether 68Ga-PSMA will identify prostate cancer more precisely than normal imaging methods (for example CT, MRI, or bone scan). A more precise identification of the location of the disease is important. Knowing where the disease is located will help to decide on the best course of action to treat the disease.

Men who have elevated tumor markers of prostate cancer are eligible for this study. Participants undergo a 68Ga-PSMA PET/CT scan before further treatment. Based on clinical information, including any prior imaging and biopsy/surgery information and follow-up information, we will determine whether 68Ga-PSMA PET/CT imaging was more accurate than the standard imaging. The study team will collect this information for up to 1 year after the 68Ga-PSMA PET/CT scan.

The results of the 68Ga-PSMA PET/CT scan will be shared with the participating patients. Also, results will be entered into the participant's medical record and shared with the treating physicians.

Study Type

Interventional

Enrollment (Actual)

1435

Phase

  • Phase 2

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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histopathological proven prostate adenocarcinoma.

  2. Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

    1. Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.
    2. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.
  3. Karnofsky performance status of ≥ 50.
  4. Age ≥ 18.
  5. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

  1. Current investigational therapy for prostate cancer.
  2. Unable to lie flat, still or tolerate a PET/CT scan.
  3. Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.
  4. Prisoner.

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: Patient participants
PET/CT imaging
Drug: 68Ga-PSMA

PET/CT imaging with 68Ga-PSMA:

68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).

Other Names:
  • Gallium-68 PSMA-HBED-CC
  • Gallium-68 PSMA-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology.
Time Frame: Up to 12 months after 68Ga-PSMA scan

Evaluation of the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.

The result of a histopathological examination of a PSMA positive lesion is obtained when available. Such data are collected as a single time point up to 12 months following the scan.
Up to 12 months after 68Ga-PSMA scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location.
Time Frame: Up to 12 months after 68Ga-PSMA scan
The sensitivity and PPV of 68Ga-PSMA PET/CT is determined on a per-patient and per-region-basis for the detection of tumor location. Confirmation is obtained by conventional imaging, clinical follow-up, and/or histopathology/biopsy where available. Results of conventional imaging, clinical follow-up, and/or histopathology is collected as a single time point up to 12 months following the scan.
Up to 12 months after 68Ga-PSMA scan
Adverse Events of 68Ga-PSMA Administration
Time Frame: 24 - 72 hours post administration
The number of adverse events were determined through clinical assessment and categorized by CTCAE 4.0.
24 - 72 hours post administration
Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT
Time Frame: 12 months post scan
Scan detection rates (in %) on a per-patient basis are given for specific PSA value ranges (a) 0.2<0.5, b) 0.5<1.0, c) 1.0<2.0, d) 2.0<5.0, e) >=5.0 ng/mL. Ideally, the 68Ga-PSMA-11 PET/CT scan detection rate would be 100% at any PSA range.
12 months post scan
Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients
Time Frame: 2 days to 12 months following the scan.
The results of this outcome measure were evaluated using a treatment plan questionnaire given to the treating physician or practitioner before the scan, at approximately 1 month (2-30 days) after the 68Ga-PSMA-11 PET scan, and at approximately 6 months (range 3 - 12 months) after the 68Ga-PSMA-11 PET scan. The treatment plan questionnaire was provided with 11 choice options. Responses to the questionnaire were compared to determine whether physicians changed their treatment plans following the PET scan.
2 days to 12 months following the scan.

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Morand R Piert, M.D., University of Michigan

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 9, 2018

Primary Completion (Actual)

August 9, 2022

Study Completion (Actual)

August 9, 2022

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 11, 2018

Study Record Updates

Last Update Posted (Actual)

November 3, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM125841

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

  • 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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