68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

Jonsson Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: PSA Level Greater Than Fifty; Stage IV Prostate Cancer AJCC v8; Prostate Carcinoma; Prostate Adenocarcinoma; Biochemically Recurrent Prostate Carcinoma; Stage IVA Prostate Cancer AJCC v8; Metastatic Prostate Carcinoma; PSA Progression; Stage IVB Prostate Cancer AJCC v8

Treatments: Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT04050215

17-001336 (Other Identifier)

NCI-2019-04439 (Registry Identifier)

Details and patient eligibility

About

This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.

Full description

PRIMARY OBJECTIVES:

I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

After completion of study, patients are followed up within 3-12 months.

Enrollment: 937 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who fulfill criteria for initial staging or restaging as outlined below:

  • Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:

    • Surgery
    • External radiation therapy (RT)
    • Other focal therapies
    • Systemic medical treatment
    • Watchful waiting

  • Assessment for subsequent treatment strategy (restaging), any of the following:

    • Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:

      • Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
      • Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA

    • Patients with known prostate cancer who undergo restaging because of new symptoms

    • Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging

    • Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed

    • Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision

• Capability to provide written informed consent

• Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion criteria

• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
• Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
• Inability to provide written informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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937 participants in 1 patient group

Diagnostic (68Ga-PSMA-11 PET/CT)

Experimental group

Description:

Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

Treatment:

Procedure: Computed Tomography

Procedure: Positron Emission Tomography

Other: Questionnaire Administration

Drug: Gallium Ga 68-labeled PSMA-11