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

• ClinicalTrials.gov Identifier: NCT04777071
• Recruitment Status: Recruiting
• First Posted: March 2, 2021
• Last Update Posted: March 29, 2023
• Sponsor: University of Washington
• Information provided by (Responsible Party): University of Washington

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
Biochemically Recurrent Prostate Carcinoma; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8	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 (Clinical Trial)
• Estimated 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
• Estimated Primary Completion Date: September 30, 2024
• Estimated Study Completion Date: March 31, 2028

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 [ Time Frame: Baseline up to 1.5 years after the last scan ]
   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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 5 years post-scan ]
9. Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Elsa Roberts; 206-667-4339; psmaresearch@uw.edu

Locations

United States, Washington

Fred Hutch/University of Washington Cancer Consortium; Recruiting

Seattle, Washington, United States, 98109

Contact: Elsa Roberts 206-667-4339 psmaresearch@uw.edu

Principal Investigator: Delphine L. Chen, M.D.

Sponsors and Collaborators

University of Washington

Investigators

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

More Information

• Responsible Party: University of Washington
• ClinicalTrials.gov Identifier: NCT04777071
• Other Study ID Numbers: RG1007462; NCI-2020-02612 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 10512 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
• First Posted: March 2, 2021
• Last Update Posted: March 29, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• 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:

Prostate

Additional relevant MeSH terms:

Carcinoma; Prostatic Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Edetic Acid; Gallium 68 PSMA-11; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Calcium Chelating Agents; Radiopharmaceuticals