Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

NCT03439033 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 1706018301
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Pathologic Lesions Detected by PSMA PET and PET/CT Compared to MP MRI

  A scan was considered positive if the clinical interpretation was suspicious based on the clinical judgement of the reader.

  At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or less

• Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region Stratified by PSA Level

  Patients were divided into subgroups based on their PSA levels and primary treatment modality. The primary treatment modality subgroups were post radical prostatectomy, post radiation therapy, and post radical prostatectomy and radiation therapy. 109 subjects out of 273 enrolled have data reported. Multiple patients sought care elsewhere and a small number of subjects had 2-year follow-up. This lead to a smaller analysis.

  At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or less

Secondary Outcomes (1)

• Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region

  At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or less

Study Arms (3)

PET/MRI

EXPERIMENTAL

PET/MRI with Gallium-68 labeled PSMA-HBED-CC: Subjects will have one visit during which they will undergo a PET/MRI after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC.

Drug: PET/MRI with Gallium-68 labeled PSMA-HBED-CC

Multiple PET/MRI

EXPERIMENTAL

Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC: Subjects will be invited to participate in two visits within two years, the second being an optional visit. During each visit, subjects will undergo a PET/MRI after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC. This arm will be restricted to subjects who plan to undergo focal therapy.

Drug: Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC

PET/CT

EXPERIMENTAL

PET/CT with Gallium-68 labeled PSMA-HBED-CC: Subjects will have one visit during which they will undergo a PET/CT after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC. PET/CT occurs if a) an MRI can't be performed concurrently; or b) the participant already had an MRI of the abdomen/pelvis or pelvis only.

Drug: PET/CT with Gallium-68 labeled PSMA-HBED-CC

Interventions

PET/MRI with Gallium-68 labeled PSMA-HBED-CC DRUG

Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

PET/MRI

Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC DRUG

Subjects have two visits (the second visit being optional) within two years. During each visit, they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

Multiple PET/MRI

PET/CT with Gallium-68 labeled PSMA-HBED-CC DRUG

Subjects have one visit, during which they will undergo one PET/CT with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

PET/CT

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Clinical and/or technical factors that would compromise statistical analysis of the PET and/or MRI.
• If part of PET/MRI cohort and patient cohort 3 or 5, subject does not plan to have a prescribed abdomen and pelvis MRI
• If part of PET/MRI cohort and patient cohort 1, 2 or 4, subject does not plan to have a prescribed pelvis MRI
• If part of PET/CT cohort and patient cohort 3 or 5, subject does not have previous MR imaging of abdomen and pelvis
• If part of PET/CT cohort and patient cohort 1, 2 or 4, subject does not have previous MR imaging of pelvis
• If part of PET/CT cohort, investigator review determines that previous MR images do not meet institutional quality standards
• If part of PET/MRI cohort, contraindications to MRI
• Contraindications to PSMA IV administration
• Other unspecified reasons that, in the opinion of investigators, make the subject unsuitable for enrollment

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Cancer Research & Treatment Fund, Inc.: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

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

One limitation is the small number of cases available for specificity analysis resulting in a negligible sample size of patients who had a true negative reference. Another limitation is multiple patients sought care at other institutions. As a result, information was not complete for several patients. Only a small number of the subjects had 2-year follow-up or underwent confirmatory biopsy, which introduces the possibility of selection bias.

Results Point of Contact

• Title: Dr. Kritika Subramanian
• Organization: Weill Cornell Medical College

krs9089@nyp.org

212-746-6000

Study Officials

• Joseph Osborne, M.D., Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects may be assigned to one of three groups, each with a different intervention in terms of either mode or frequency

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 20, 2018
• Study Start: April 3, 2018
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: March 13, 2023
• Results First Posted: March 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)