68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy

Jonsson Comprehensive Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Metastatic Malignant Neoplasm in the Bone; Biochemically Recurrent Prostate Carcinoma; Stage IVA Prostate Cancer AJCC v8; Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Treatments: Procedure: Positron Emission Tomography; Other: Gallium Ga 68 Gozetotide; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT04928820

21-000102

NCI-2021-03575 (Registry Identifier)

Details and patient eligibility

About

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

Full description

PRIMARY OBJECTIVE:

I. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression.

SECONDARY OBJECTIVES:

I. To compare the number of lesions rated as positive for bone metastases between the two imaging tests.

II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c).

III. To compare the positive predictive value (PPV) per-patient in patients with lesion validation (follow-up imaging or biopsy).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT.

Enrollment: 22 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen [PSA] level >= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)

• Patients with bone scan scheduled or performed

  • Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between
  • Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized

• Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility

• Patients or their legal representatives must have the ability to read, understand and provide written informed consent

Exclusion criteria

• Initiation of a new therapy between the PSMA PET/CT and the bone scans
• Inability to provide written informed consent
• Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

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

Experimental group

Description:

Patients receive gallium Ga 68 gozetotide IV. After 50-100 minutes, patients undergo whole body PET/CT.

Treatment:

Other: Gallium Ga 68 Gozetotide

Procedure: Computed Tomography

Procedure: Positron Emission Tomography