Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

NCT ID: NCT02918357

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 385 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-15
• Study Completion Date: 2017-09-21

Brief Summary

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

Detailed Description

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ga-68 labeled PSMA-11 PET

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.

Group Type: EXPERIMENTAL

Ga-68 labeled PSMA-11 PET

Intervention Type: DRUG

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Interventions

Ga-68 labeled PSMA-11 PET

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Intervention Type: DRUG

Other Intervention Names

Ga-68 labeled DKFZ-PSMA-11; Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC; Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC; Ga-68 labeled HBED-CC PSMA

Eligibility Criteria

Inclusion Criteria

• Histopathological proven prostate adenocarcinoma.
• Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

• Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation

• PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
• Confirmatory persistent PSA greater than 0.2 ng/mL
• Post-radiation therapy -ASTRO-Phoenix consensus definition

• Nadir + greater than or equal to 2 ng/mL rise in PSA
• Karnofsky performance status of greater than 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

• Investigational therapy for prostate cancer.
• Unable to lie flat, still or tolerate a PET scan.
• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Thomas Hope

Assistant Professor of Radiology and Biomedical Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Hope, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2018-00039

Identifier Type: REGISTRY

Identifier Source: secondary_id

165510

Identifier Type: -

Identifier Source: org_study_id