68Ga PSMA in Preprostatectomy Patients

68Ga PSMA-HBED-CC in Intermediate to High-Risk Preprostatectomy Patients

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker.

To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasm; Prostatic Neoplasm of Uncertain Behavior
• Intervention / Treatment: Drug: Ga-68 PSMA-HBED-CC PET

Detailed Description

This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated.

Men who are scheduled to undergo a prostatectomy are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before the prostatectomy. Information from the prostatectomy, including any MRI, CT, or ultrasound imaging, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging.

Depending on the prostatectomy findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but the surgery/biopsy results do not.

The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Biopsy-proven prostate adenocarcinoma
• Intermediate to high-risk disease, defined as one of the following factors: PSA > 10, T2b or greater, or a Gleason score of 7 or greater
• A PSA level resulted within the past 2 months
• Planned prostatectomy with lymph node dissection
• Karnofsky performance status (KPS) greater than or equal to 50 (ECOG/WHO 0, 1, or 2) within the last 3 months
• Must be treatment naïve (not have received neoadjuvant chemotherapy, radiation therapy, hormonal therapy, androgen deprivation therapy, or focal ablation techniques (e.g., HiFu)
• Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations
• Ability to understand and the willingness to provide informed consent.

Exclusion Criteria:

• Cannot receive furosemide
• Allergy to sulfa or sulfa-containing medications
• History of Stevens-Johnson syndrome
• Known Paget's disease
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga PSMA PET scan; Ga-68 PSMA-HBED-CC PET	Drug: Ga-68 PSMA-HBED-CC PET; Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.; Other Names: Gallium-68 PSMA-HBED-CC PET scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	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.	within 2 weeks of prostatectomy
Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	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.	within 2 weeks of prostatectomy
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	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.	within 2 weeks of prostatectomy
Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	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.	within 2 weeks of prostatectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic Nodal Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Visceral Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Specificity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy
Negative Predictive Value (NPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	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.	Within 12 months of prostatectomy

Collaborators and Investigators

• Sponsor: Michael Graham PhD, MD
• Collaborators: University of Iowa; Holden Comprehensive Cancer Center
• Investigators: Study Chair: Michael Graham, MD, PhD, University of Iowa

Publications and helpful links

General Publications

• van Leeuwen PJ, Emmett L, Ho B, Delprado W, Ting F, Nguyen Q, Stricker PD. Prospective evaluation of 68Gallium-prostate-specific membrane antigen positron emission tomography/computed tomography for preoperative lymph node staging in prostate cancer. BJU Int. 2017 Feb;119(2):209-215. doi: 10.1111/bju.13540. Epub 2016 Jun 18.
• Eiber M, Maurer T, Souvatzoglou M, Beer AJ, Ruffani A, Haller B, Graner FP, Kubler H, Haberkorn U, Eisenhut M, Wester HJ, Gschwend JE, Schwaiger M. Evaluation of Hybrid (6)(8)Ga-PSMA Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. J Nucl Med. 2015 May;56(5):668-74. doi: 10.2967/jnumed.115.154153. Epub 2015 Mar 19. Erratum In: J Nucl Med. 2016 Aug;57(8):1325.
• Maurer T, Gschwend JE, Rauscher I, Souvatzoglou M, Haller B, Weirich G, Wester HJ, Heck M, Kubler H, Beer AJ, Schwaiger M, Eiber M. Diagnostic Efficacy of (68)Gallium-PSMA Positron Emission Tomography Compared to Conventional Imaging for Lymph Node Staging of 130 Consecutive Patients with Intermediate to High Risk Prostate Cancer. J Urol. 2016 May;195(5):1436-1443. doi: 10.1016/j.juro.2015.12.025. Epub 2015 Dec 9.
• Afshar-Oromieh A, Avtzi E, Giesel FL, Holland-Letz T, Linhart HG, Eder M, Eisenhut M, Boxler S, Hadaschik BA, Kratochwil C, Weichert W, Kopka K, Debus J, Haberkorn U. The diagnostic value of PET/CT imaging with the (68)Ga-labelled PSMA ligand HBED-CC in the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2015 Feb;42(2):197-209. doi: 10.1007/s00259-014-2949-6. Epub 2014 Nov 20.
• Green MA, Eitel JA, Fletcher JW, Mathias CJ, Tann MA, Gardner T, Koch MO, Territo W, Polson H, Hutchins GD. Estimation of radiation dosimetry for 68Ga-HBED-CC (PSMA-11) in patients with suspected recurrence of prostate cancer. Nucl Med Biol. 2017 Mar;46:32-35. doi: 10.1016/j.nucmedbio.2016.11.002. Epub 2016 Nov 4.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): July 22, 2021
• Study Completion (Actual): July 22, 2021

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: 68Ga-PSMA-11; (68Ga)Glu-urea-Lys(Ahx)-HBED-CC; 68Ga PSMA-HBED-CC
• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Neoplasms; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Edetic Acid; Gallium 68 PSMA-11
• Other Study ID Numbers: 201708824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Codified data will be archived and stored in an imaging repository with limited metadata for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.
• IPD Sharing Time Frame: Available as requested. Data will be archived indefinitely for research purposes.
• IPD Sharing Access Criteria: Individuals seeking use of these data should contact the study chair.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No