Prostate Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT04777071

Recruitment Status:

Recruiting

Sponsor:

University of Washington

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States More Info
Elsa Roberts
Contact
206-667-4339
[email protected]
Delphine L. Chen, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT04777071

Recruitment Status:

Recruiting

Sponsor:


University of Washington

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