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NCT02918357 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2, PHASE3
Status at capture
COMPLETED
Registry last update
2019-12-02

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation

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outcome · POSTED

Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation

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outcome · POSTED

PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up

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outcome · POSTED

PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up

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outcome · POSTED

Sensitivity on a Per-patient Basis

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outcome · POSTED

Sensitivity on a Per-region Basis

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outcome · POSTED

Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value

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outcome · POSTED

Inter-reader Agreement Per-region

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outcome · POSTED

Percentage of Participants With Change in Clinical Management

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outcome · POSTED

Safety Assessment - Heart Rate

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outcome · POSTED

Safety Assessment - Blood Pressure

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histopathological proven prostate adenocarcinoma. * Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). * Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation * PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and, * Confirmatory persistent PSA greater than 0.2 ng/mL * Post-radiation therapy -ASTRO-Phoenix consensus definition * Nadir + greater than or equal to 2 ng/mL rise in PSA * Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent). * Age \> 18. * Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: * Investigational therapy for prostate cancer. * Unable to lie flat, still or tolerate a PET scan. * Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer. * Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
healthy Volunteers
false
minimum Age
18 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
    intervention Names
    1. Drug: Ga-68 labeled PSMA-11 PET
    label
    Ga-68 labeled PSMA-11 PET
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Ga-68 labeled PSMA-11 PET
    description
    Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the 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.
    name
    Ga-68 labeled PSMA-11 PET
    other Names
    1. Ga-68 labeled DKFZ-PSMA-11
    2. Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC
    3. Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC
    4. Ga-68 labeled HBED-CC PSMA
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
DIAGNOSTIC
Enrollment
count
385
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.
    measure
    Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation
    time Frame
    1 month
  2. description
    PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.
    measure
    Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation
    time Frame
    1 month
secondary Outcomes
  1. description
    PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.
    measure
    PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
    time Frame
    1 month
  2. description
    PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.
    measure
    PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up
    time Frame
    1 month
  3. description
    Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.
    measure
    Sensitivity on a Per-patient Basis
    time Frame
    1 month
  4. description
    Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.
    measure
    Sensitivity on a Per-region Basis
    time Frame
    1 month
  5. description
    Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-\<0.5; 0.5-\<1.0; 1.0-\<2.0; 2.0-\<5.0, and ≥5.0).
    measure
    Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value
    time Frame
    1 month
  6. description
    Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).
    measure
    Inter-reader Agreement Per-region
    time Frame
    1 month
  7. description
    Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.
    measure
    Percentage of Participants With Change in Clinical Management
    time Frame
    Up to 1 year
  8. description
    Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
    measure
    Safety Assessment - Heart Rate
    time Frame
    1 day
  9. description
    Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.
    measure
    Safety Assessment - Blood Pressure
    time Frame
    1 day
Full study description
brief Summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
detailed Description
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.
Source references
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        on a study of another formulation of gallium Ga 68 gozetotide. Below is a display of the results of the prospective, open label study PSMA-BCR (NCT02940262 and NCT02918357, referred to as Study 2). This two-center study enrolled 635 patients with biochemical evidence of recurrent prostate cancer after definitive therapy, defined
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      occurrences
      1. context exact
        lium Ga 68 Gozetotide Injection were established in two prospective, open-label studies, PSMA-PreRP (NCT03368547 and NCT02919111) and PSMA-BCR (NCT02940262 and NCT02918357), in men with prostate cancer. PSMA-PreRP This two-center study enrolled 325 patients with biopsy-proven prostate cancer who were considered candidates for pro
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        s of another formulation of gallium Ga 68 gozetotide injection. Below is a display of the result of the prospective, open label study PSMA-BCR (NCT02940262 and NCT02918357, referred to as Study 2). This two-center study enrolled 635 patients with biochemical evidence of recurrent prostate cancer after definitive therapy, defined
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    Preserved source evidence · Not medical advice