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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

141

participants targeted

Target at P75+ for phase_2

Timeline

51mo left

Started May 2021

Longer than P75 for phase_2

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9.2 years study duration

Study Progress54%

May 2021Jul 2030

First Submitted

Initial submission to the registry

February 25, 2021

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed

4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2030

Expected

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

4.2 years

First QC Date

February 25, 2021

Last Update Submit

January 7, 2026

Conditions

Biochemically Recurrent Prostate Carcinoma Metastatic Castration-Resistant Prostate Carcinoma Prostate Adenocarcinoma Stage IIC Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8

Keywords

Prostate

Outcome Measures

Primary Outcomes (1)

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 equivocal lesion cohorts). 95% confidence intervals (CIs) will be used to express precision of the estimates.
Baseline up to 1.5 years after the last scan

Secondary Outcomes (9)

Major change in management
Baseline up to 5 years post-scan
Minor change in management
Baseline up to 5 years post-scan
68Ga-PSMA-11 standardized uptake value maximum (SUVmax)
Up to 6 weeks after systemic therapy initiation
68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)
Up to 6 weeks after systemic therapy initiation
Change in 68Ga-PSMA-11 SUVmax
Baseline up to 6 weeks after systemic therapy initiation
+4 more secondary outcomes

Study Arms (1)

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

EXPERIMENTAL

Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes 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 and on study.

Procedure: Computed TomographyDrug: Gallium Ga 68 GozetotideProcedure: Positron Emission TomographyProcedure: Magnetic Resonance ImagingProcedure: Bone ScanOther: Electronic Health Record Review

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT scan

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography