Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients (PSMA PreRP)

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Ga-68 labeled PSMA-11 PET

Study type

Interventional

Funder types

Other

Identifiers

NCT02919111

NCI-2018-00038 (Registry Identifier)

16559

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 it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.

Full 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 pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis.

This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring Ga-68-PSMA-11 to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.

Enrollment

299 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Biopsy proven prostate adenocarcinoma.
Planned prostatectomy with lymph node dissection.
Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).
Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
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

Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
Including focal ablation techniques (HiFu).
Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.