Clinical trial NCT02919111: Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients
Official title: Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 299
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 high risk disease prior to prostatectomy.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
timeFrame: Up to 1 year
measure: Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
timeFrame: Up to 1 year
measure: Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
timeFrame: Up to 1 year
measure: Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of Participants With Grade 3 Treatment-related Adverse Events
timeFrame: Up to 3 days
measure: Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
timeFrame: Up to 1 year
measure: Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
timeFrame: Up to 1 year
measure: Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
timeFrame: Up to 1 year
measure: Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases
timeFrame: Up to 1 year
measure: Sensitivity of PSMA PET for the Detection of Visceral Metastases
timeFrame: Up to 1 year
measure: Specificity of PSMA PET for the Detection of Visceral Metastases
timeFrame: Up to 1 year
measure: Positive Predictive Value of PSMA PET Visceral Metastases
timeFrame: Up to 1 year
measure: Negative Predictive Value of PSMA PET for the Detection of Visceral Metastases
timeFrame: Up to 1 year
measure: Sensitivity of PSMA PET for the Detection of Osseous Metastases
timeFrame: Up to 1 year
measure: Specificity of PSMA PET for the Detection of Osseous Metastases
timeFrame: Up to 1 year
measure: Positive Predictive Value of PSMA PET for the Detection of Osseous Metastases
timeFrame: Up to 1 year
measure: Negative Predictive Value of PSMA PET for the Detection of Osseous Metastases
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Hope, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.