Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer

NCT03689582 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: UMCC 2018.072HUM00146602
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find out whether imaging of the prostate with a new molecule called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers that would be considered in need for treatment.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of Two Different Radiologic Imaging Techniques, Fusion PET/MRI and Standard MRI, With Histopathologic Reference Data From Prostate Biopsy

  Fusion PET/MRI is the combination of 68Ga-PSMA Positron Emission Tomography/Computed Tomography (PET/CT) plus Multiparametric MRI (mpMRI)-guided biopsy. Reference standard will be pathology-defined as targeted plus standard prostate biopsy, and prostatectomy, when available. The original intent was to determine the sensitivity and specificity of standard-of-care Multiparametric MRI (mpMRI) alone (using PI-RADS version 2) and fusion PET/MRI for the detection of primary Gleason ≥3+4 cancer, and to estimate the positive likelihood ratio (LR) of each. However, due to pandemic-related early closure of the study, enrollment was less than 15% of the enrolment goal necessary to achieve statistical power. Therefore, it is not possible to responsibly report the originally listed outcome measure of likelihood ratio. Instead, the results table displays the summary of collected imaging data, categorized by type of scan, in comparison to the reference standard histopathology.

  Up to ~4 weeks (after planned, standard-of-care biopsy).

Secondary Outcomes (1)

• Adverse Events of 68Ga-PSMA Administration

  24 hours post injection

Study Arms (1)

68Ga-PSMA

EXPERIMENTAL

PET/CT imaging with 68Ga-PSMA

Drug: 68Ga-PSMA

Interventions

68Ga-PSMA DRUG

Positron Emission Tomography/Computed Tomography (PET/CT) imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).

Also known as: Gallium-68 PSMA-HBED-CC, Gallium-68 PSMA-11

68Ga-PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
• Treating physician has already indicated a need for a prostate biopsy procedure.
• Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

You may not qualify if:

• Prostate biopsy within 12 weeks before enrollment
• Acute prostatitis within the last 6 months
• Current non-urologic bacterial infection requiring active treatment with antibiotics
• Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
• Body weight greater than 350 lbs (158 Kg)
• Inability or unwillingness to receive a prostate biopsy procedure
• Unable to lie flat, still, or tolerate a PET/CT scan
• Unable to provide own consent
• Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Hicks RM, Simko JP, Westphalen AC, Nguyen HG, Greene KL, Zhang L, Carroll PR, Hope TA. Diagnostic Accuracy of 68Ga-PSMA-11 PET/MRI Compared with Multiparametric MRI in the Detection of Prostate Cancer. Radiology. 2018 Dec;289(3):730-737. doi: 10.1148/radiol.2018180788. Epub 2018 Sep 18.

  PMID: 30226456 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Morand Piert, MD
• Organization: University of Michigan Rogel Cancer Center

mpiert@med.umich.edu

734-936-5388

Study Officials

• Morand R Piert, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: September 28, 2018
• Study Start: November 13, 2018
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: January 5, 2022
• Results First Posted: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Available as requested. Data will be archived indefinitely for research purposes.
• Access Criteria: Individuals seeking use of these data should contact the study chair.

Locations

US (1)