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

Phase 2

Recruiting

• Conditions: Castration-Resistant Prostate Carcinoma; Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Biochemically Recurrent Prostate Carcinoma
• Interventions: Procedure: Computed Tomography; Drug: Gallium Ga 68 Gozetotide; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Bone Scan

• Registration Number: NCT04777071
• Lead Sponsor: University of Washington

Brief Summary

This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET 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 or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening.

After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-02
• Study Start: 2021-05-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-12-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 213

Inclusion Criteria

• Pathologically proven prostate adenocarcinoma

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

  • Grade group 4-5 and/or
  • PSA > 20 ng/mL

• For patients with biochemical recurrence (biochemical recurrence cohort):

  • 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 (treatment monitoring cohort):

  • Diagnosis of metastatic castration-resistant prostate cancer
  • At least one or more measurable ( > 1 cm diameter in short axis) or evaluable lesions by any modality obtained within the past 60 days
  • Planned for treatment with standard of care androgen receptor pathway inhibitor or chemotherapy

• This can include patients who have already undergone a standard of care Ga-68 PSMA PET/CT or PET/MR for determining eligibility for Lu-177 PSMA therapy, for whom the PET/CT or PET/MR did not confirm eligibility for treatment with Lu-177 PSMA, and who are planned to start treatment on chemotherapy or androgen receptor signaling inhibitor (ARSI) within 30 days of the Ga-68 PSMA PET. This can also include patients who have obtained a standard of care Ga-68 PSMA PET/CT or PET/MR for rising PSA to help with restaging prior to starting new treatment with ARSI or chemotherapy, even if Lu-177 PSMA is not being considered at that time. Scan 1 must be completed within 30 days of enrollment. Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort)

• 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)

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

• Ability to understand and willingness to provide informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)	Gallium Ga 68 Gozetotide	Patients receive gallium Ga 68-labeled PSMA-11 IV then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening.
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)	Positron Emission Tomography	Patients receive gallium Ga 68-labeled PSMA-11 IV then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening.
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)	Magnetic Resonance Imaging	Patients receive gallium Ga 68-labeled PSMA-11 IV then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening.
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)	Computed Tomography	Patients receive gallium Ga 68-labeled PSMA-11 IV then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening.
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)	Bone Scan	Patients receive gallium Ga 68-labeled PSMA-11 IV then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening.

Primary Outcome Measures

Name	Time	Method
Change in planned management strategy	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 equivocal lesion cohorts). 95% confidence intervals (CIs) will be used to express precision of the estimates.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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. This analysis applies to the subjects enrolled in the initial staging (N=30), biochemical recurrence (N=30), and equivocal lesions cohorts (N=43).
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.
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.
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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States