Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence

Thomas Hope

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Ga-68 labeled PSMA-11 PET

Study type: Interventional

Funder types: Other

Identifiers

NCT03353740

175518

NCI-2018-00040 (Registry Identifier)

Details and patient eligibility

About

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Enrollment: 346 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Histopathologically proven prostate adenocarcinoma.

• Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

  • Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy

    • PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.

  • Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy

    • Nadir + greater than or equal to 2 ng/mL rise in PSA

• Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).

• Age >= 18.

• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria

• Unable to lie flat, still or tolerate a PET scan.
• Concomitant investigational therapy.
• Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
• Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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346 participants in 1 patient group

Ga-68 labeled PSMA-11 PET

Experimental group

Description:

PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Treatment:

Drug: Ga-68 labeled PSMA-11 PET