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Completed

NCT Number: NCT03803475

Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues

Primary Objective:

Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, age >= 18.
  • Histopathologically proven prostate adenocarcinoma.
  • Concern for metastatic disease in one of the following settings:
  • Initial staging with intermediate to high risk prostate cancer.
  • Biochemical recurrence after initial therapy.
  • Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

  • Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Treatment and study plan

Ga-68 labeled PSMA-11

Drug

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Other names: Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED- CC, Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC, Ga-68 labeled HBED-CC PSMA

Positron emission tomography-computed tomography (PET/CT)

Device

Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session

Other names: PET-CT

Positron emission tomography-magnetic resonance imaging (PET/MRI)

Device

A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session

Other names: PET-MRI

Primary outcomes

  1. Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group

    Time frame: 1 day

    Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

  2. Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group

    Time frame: 1 day

    Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

  3. Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group

    Time frame: 1 day

    Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

  4. Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group

    Time frame: 1 day

    Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

  5. Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group

    Time frame: 1 day

    Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.

Sponsors and collaborators

Lead sponsor

Thomas Hope

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2019
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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