Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients
PSMA PET
Evaluation of Gallium-68 HBED-CC-PSMA Imaging in Prostate Cancer Patients
2 other identifiers
interventional
225
1 country
1
Brief Summary
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Dec 2015
Shorter than P25 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedStudy Start
First participant enrolled
December 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2016
CompletedResults Posted
Study results publicly available
December 22, 2020
CompletedDecember 22, 2020
November 1, 2020
10 months
September 29, 2015
November 3, 2020
November 26, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval.
1 day
Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
1 day
Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
1 day
Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
one month
Secondary Outcomes (2)
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
Up to 1 year
Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management
Up to 1 year
Study Arms (3)
High-risk prostate cancer pre-prostatectomy (preRP) population
EXPERIMENTALPatients with high-risk prostate cancer pre-prostatectomy. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Biochemical Recurrence (BCR)
EXPERIMENTALPatients with prostate cancer with biochemical recurrence Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Castrate Resistant Prostate cancer (CRCP) population
EXPERIMENTALPatients with castrate resistant prostate cancer. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Interventions
The imaging agent (Ga-68 HBED-CC PSMA) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET/CT imaging. The one-time nominal injected dose will be 3 to 7 millicurie (mCi) containing 10 - 25 μg Ga-68 HBED-CC PSMA.
Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/CT scan includes two parts: a PET scan and a CT scan. The CT portion of the scan produces a 3-D image that shows a patient's anatomy. The PET scan demonstrates function and what's occurring on a cellular level. The PET scan is unique because it images the radiation emitted from the patient while the CT records anatomical x-rays, showing the same area from another perspective
Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Coverage for the scan will extend from the patients vertex through the mid thighs. We will use 4 minute acquisitions per bed position for PET imaging.
Eligibility Criteria
You may qualify if:
- Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:
- Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score ≥ 5, Prostate-specific antigen (PSA) ≥ 15 ng/mL and/or Gleason score ≥ 4+4.
- Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months.
- i. These patients may have received androgen deprivation therapy prior to imaging.
- Patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27).
- i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment
- Age \> 18.
- 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.
You may not qualify if:
- Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Hopelead
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94107, United States
Related Publications (4)
Lawhn-Heath C, Flavell RR, Behr SC, Yohannan T, Greene KL, Feng F, Carroll PR, Hope TA. Single-Center Prospective Evaluation of 68Ga-PSMA-11 PET in Biochemical Recurrence of Prostate Cancer. AJR Am J Roentgenol. 2019 Aug;213(2):266-274. doi: 10.2214/AJR.18.20699. Epub 2019 Apr 30.
PMID: 31039025RESULTDjaileb L, Armstrong WR, Thompson D, Gafita A, Farolfi A, Rajagopal A, Grogan TR, Nguyen K, Benz MR, Hotta M, Barbato F, Ceci F, Schwarzenbock SM, Unterrainer M, Zacho HD, Juarez R, Cooperberg M, Carroll P, Washington S, Reiter RE, Eiber M, Herrmann K, Fendler WP, Czernin J, Hope TA, Calais J. Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial. Eur Urol. 2023 Dec;84(6):588-596. doi: 10.1016/j.eururo.2023.06.022. Epub 2023 Jul 21.
PMID: 37482512DERIVEDHope 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.
PMID: 34529005DERIVEDHope TA, Aggarwal R, Chee B, Tao D, Greene KL, Cooperberg MR, Feng F, Chang A, Ryan CJ, Small EJ, Carroll PR. Impact of 68Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2017 Dec;58(12):1956-1961. doi: 10.2967/jnumed.117.192476. Epub 2017 May 18.
PMID: 28522741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Over one-half of the patients subsequently underwent radiation therapy and androgen deprivation therapy. In these patients PSA level almost universally falls to zero, and therefore no follow-up imaging is performed, effectively removing a large proportion of patients from our imaging follow-up.
Results Point of Contact
- Title
- Dr. Thomas Hope, MD
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Hope
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 29, 2015
First Posted
November 23, 2015
Study Start
December 18, 2015
Primary Completion
October 24, 2016
Study Completion
October 24, 2016
Last Updated
December 22, 2020
Results First Posted
December 22, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share