Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy

Jonsson Comprehensive Cancer Center

Status and phase: Completed; Phase 3

Conditions: Prostate Adenocarcinoma; Recurrent Prostate Carcinoma

Treatments: Radiation: Gallium Ga 68 Gozetotide; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02940262

NCI-2016-01212 (Registry Identifier)

16-001095

Details and patient eligibility

About

This clinical trial studies how well gallium Ga 68-labeled prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) works in detecting prostate cancer that has come back (recurrent) in patients after initial therapy. Diagnostic procedures, such as gallium Ga 68-labeled PSMA-11 PET/CT, may help doctors detect tumors that have come back after initial therapy.

Full description

PRIMARY OBJECTIVE:

I. To assess the sensitivity on a per-patient and per-region-basis of Gallium Ga 68 Gozetotide (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

SECONDARY OBJECTIVES:

I. To assess the positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up (composite reference standard).

II. To assess the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy only.

III. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0).

IV. To assess the impact of 68Ga-PSMA-11 PET on clinical management in biochemical recurrence (BCR) patients.

V. To assess the inter-reader reproducibility. VI. To assess the safety of 68Ga-PSMA-11 PET. VII. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA velocity and PSA doubling-time.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.

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

Enrollment: 1,138 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathological proven prostate adenocarcinoma

• Rising PSA after definitive therapy with prostatectomy or radiation therapy.

  • Post radical prostatectomy (RP)

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

  • Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition

    • 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)

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

Exclusion criteria

• Concomitant investigational therapy
• Known inability to lie flat, remain still or tolerate a PET scan
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,138 participants in 1 patient group

Treatment (68Ga-PSMA-11)

Experimental group

Description:

Patients receive gallium Ga 68-labeled PSMA-11 IV. Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Positron Emission Tomography

Radiation: Gallium Ga 68 Gozetotide