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

Primary Purpose

Biochemically Recurrent Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Gallium Ga 68 Gozetotide
Positron Emission Tomography
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Biochemically Recurrent Prostate Carcinoma focused on measuring Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in planned management strategy
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

Major change in management
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.
Minor change in management
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.
68Ga-PSMA-11 standardized uptake value maximum (SUVmax)
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.
68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)
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.
Change in 68Ga-PSMA-11 SUVmax
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.
Change in 68Ga-PSMA-11 SULpeak
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.
Change in size of measurable metastatic lesions
Assessed by CT or magnetic resonance imaging (MRI) by RECIST 1.1 criteria.
Validated pain scale score
Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens
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.

Full Information

First Posted
February 25, 2021
Last Updated
September 29, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT04777071
Brief Title
An Investigational Scan (68Ga-PSMA-11 PET/CT) for the Imaging of Prostate Cancer
Official Title
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biochemically Recurrent Prostate Carcinoma, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8
Keywords
Prostate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo PET/CT scan
Intervention Type
Drug
Intervention Name(s)
Gallium Ga 68 Gozetotide
Other Intervention Name(s)
(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
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT scan
Primary Outcome Measure Information:
Title
Change in planned management strategy
Description
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.
Time Frame
Baseline up to 1.5 years after the last scan
Secondary Outcome Measure Information:
Title
Major change in management
Description
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.
Time Frame
Baseline up to 5 years post-scan
Title
Minor change in management
Description
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.
Time Frame
Baseline up to 5 years post-scan
Title
68Ga-PSMA-11 standardized uptake value maximum (SUVmax)
Description
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.
Time Frame
Up to 6 weeks after systemic therapy initiation
Title
68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)
Description
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.
Time Frame
Up to 6 weeks after systemic therapy initiation
Title
Change in 68Ga-PSMA-11 SUVmax
Description
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.
Time Frame
Baseline up to 6 weeks after systemic therapy initiation
Title
Change in 68Ga-PSMA-11 SULpeak
Description
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.
Time Frame
Baseline up to 6 weeks after systemic therapy initiation
Title
Change in size of measurable metastatic lesions
Description
Assessed by CT or magnetic resonance imaging (MRI) by RECIST 1.1 criteria.
Time Frame
Baseline up to 5 years post-scan
Title
Validated pain scale score
Time Frame
Up to 5 years post-scan
Title
Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens
Description
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.
Time Frame
Up to 5 years post-scan

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akshata Mathur
Phone
206.667.5801
Email
psmaresearch@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine L. Chen, M.D.
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akshata Mathur
Phone
206-667-5801
Email
psmaresearch@uw.edu
First Name & Middle Initial & Last Name & Degree
Delphine L. Chen, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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