An Investigational Scan (68Ga-PSMA-11 PET/CT) for the Imaging of Prostate Cancer

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT04777071
Collaborator
(none)
150
1
1
75.5
2

Study Details

Study Description

Brief Summary

This trial studies how well 68Ga-PSMA-11 PET/CT scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT may find and diagnose prostate cancer and improve monitoring of treatment response.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Computed Tomography
  • Drug: Gallium Ga 68 Gozetotide
  • Procedure: Positron Emission Tomography
Phase 2

Detailed Description

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) then undergo PET/CT over 2-3 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT scan 6 weeks after initiating therapy.

After the completion of study, patients are followed for up to 5 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Actual Study Start Date :
May 17, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT)

Patients receive gallium Ga 68-labeled PSMA-11 IV then undergo PET/CT over 2-3 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT scan 6 weeks after initiating therapy.

Procedure: Computed Tomography
Undergo PET/CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography
  • Drug: Gallium Ga 68 Gozetotide
    Given IV
    Other Names:
  • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-DKFZ-PSMA-11
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA
  • 68Ga-PSMA-11
  • 68Ga-PSMA-HBED-CC
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga PSMA
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled PSMA-11
  • GA-68 PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium Ga 68-labeled PSMA-11
  • GALLIUM GA-68 GOZETOTIDE
  • Gallium-68 PSMA
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • GaPSMA
  • PSMA-HBED-CC GA-68
  • Procedure: Positron Emission Tomography
    Undergo PET/CT scan
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • Outcome Measures

    Primary Outcome Measures

    1. Change in planned management strategy [Baseline up to 6 months post-scan 1]

      Assessed using conventional imaging with executed management strategy incorporating information from first (scan 1) 68Ga-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT), regardless of treatment modality. Will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and pre/post treatment). 95% confidence intervals (CIs) will be used to express precision of the estimates.

    Secondary Outcome Measures

    1. Major change in management [Baseline up to 5 years post-scan]

      Defined as a change in treatment modality (e.g. change from systemic therapy to radiation therapy). Will compare by planned management strategy using conventional imaging and executed management strategy incorporating information from scan 1 68Ga-PSMA-11 PET/CT, regardless of treatment modality. 95% CIs will be used to express precision of the estimates.

    2. Minor change in management [Baseline up to 5 years post-scan]

      Defined as changes within a treatment modality (e.g. change in planned radiation field or change in systemic therapy regimen to be used for a patient already planned to receive systemic therapy). Defined as a post-scan change within a treatment modality (e.g. alteration to salvage radiation field). 95% CIs will be used to express precision of the estimates.

    3. 68Ga-PSMA-11 standardized uptake value maximum (SUVmax) [Up to 6 weeks after systemic therapy initiation]

      Changes in uptake will be compared among all groups using analysis of variance (ANOVA) or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test.

    4. 68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak) [Up to 6 weeks after systemic therapy initiation]

      Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test.

    5. Change in 68Ga-PSMA-11 SUVmax [Baseline up to 6 weeks after systemic therapy initiation]

      Expressed as percent (%) change from scan 1. Will be determined and correlated with change in prostate specific antigen (PSA) level and Response Evaluation Criteria in Solid Tumors (RECIST) for measurable lesions, as assessed using Pearson's or Spearman's correlation coefficient. The relationship of changes in SUVmax and SULpeak with clinical response categories will also be assessed graphically and summarized overall with Spearman's rank correlation coefficient. Clinical response categories will be defined as complete response, partial response, stable disease, and progressive disease and determined by clinical assessment, conventional imaging, and biopsy (if available). The subgroup analysis of this group will be exploratory. Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test.

    6. Change in 68Ga-PSMA-11 SULpeak [Baseline up to 6 weeks after systemic therapy initiation]

      Expressed as percent (%) change from scan 1. Will be determined and correlated with change in prostate specific antigen (PSA) level and Response Evaluation Criteria in Solid Tumors (RECIST) for measurable lesions, as assessed using Pearson's or Spearman's correlation coefficient. The relationship of changes in SUVmax and SULpeak with clinical response categories will also be assessed graphically and summarized overall with Spearman's rank correlation coefficient. Clinical response categories will be defined as complete response, partial response, stable disease, and progressive disease and determined by clinical assessment, conventional imaging, and biopsy (if available). The subgroup analysis of this group will be exploratory. Changes in uptake will be compared among all groups using ANOVA or the Kruskal-Wallis test and between pairs of groups using the t-test or Wilcoxon rank-sum test.

    7. Change in size of measurable metastatic lesions [Baseline up to 5 years post-scan]

      Assessed by CT or magnetic resonance imaging (MRI) by RECIST 1.1 criteria.

    8. Validated pain scale score [Up to 5 years post-scan]

    9. Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens [Up to 5 years post-scan]

      Will be performed only in patients with biopsy or surgical resection specimens. Lesions on each scan will be categorized as positive or negative. Pathology results will also be scored as positive or negative based on the clinical interpretation. These results will then be used to calculate accuracy with 95% CIs. CIs will be calculated using the non-parametric bootstrap with resampling by patient to account to dependence between lesions from the same patient.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pathologically proven prostate adenocarcinoma

    • For the initial staging arm, high risk characteristics, including any of the following:

    • Grade group 4-5 and/or

    • PSA > 20 ng/mL

    • For patients with biochemical recurrence:

    • Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy)

    • If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence

    • If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence)

    • For patients undergoing systemic therapy:

    • Diagnosis of metastatic castration-resistant prostate cancer

    • At least one or more measurable (> 1 cm diameter in short axis) or evaluable lesions by conventional imaging

    • Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment

    • No other malignancy within the past 2 years (with the exception of skin basal cell or cutaneous superficial squamous cell carcinoma, superficial bladder cancer, carcinoma in situ in any location, or Rai Stage 0 chronic lymphocytic leukemia, which are allowed)

    • Karnofsky performance status (KPS) >= 50, Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) grades 0, 1, or 2

    • Ability to understand and willingness to provide informed consent

    Exclusion Criteria:
    • Allergy to furosemide

    • History of Stevens-Johnson syndrome

    • History or diagnosis of Paget's disease

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • University of Washington

    Investigators

    • Principal Investigator: Delphine L. Chen, M.D., Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Washington
    ClinicalTrials.gov Identifier:
    NCT04777071
    Other Study ID Numbers:
    • RG1007462
    • NCI-2020-02612
    • 10512
    First Posted:
    Mar 2, 2021
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Washington
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 8, 2022