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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Terminated

CT.gov ID

NCT03439033

Collaborator

Cancer Research & Treatment Fund, Inc (Other)

273

Enrollment

Location

Arms

37.1

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: PET/MRI with Gallium-68 labeled PSMA-HBED-CC Drug: Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC Drug: PET/CT with Gallium-68 labeled PSMA-HBED-CC	Phase 2

Detailed Description

This is a multi-reader methodological study comparing the diagnostic value of 68Ga-PSMA-HBED-CC PET/CT or 68Ga-PSMA-HBED-CC PET/MRI over MRI alone, using histologic confirmation or serial follow-up for up to 2 years as the gold standard for determination of primary prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this will demonstrate the superiority of 68Ga-PSMA-HBED-CC PET to MRI for sensitivity, and the non-inferiority of 68Ga-PSMA-HBED-CC PET to MRI for specificity.This is a paired, case-control design that is appropriate to statistically evaluate the difference in sensitivity and specificity between the two imaging modalities. Therefore, the estimation of population prevalence is not a study objective, and estimation of clinical utility through calculation of positive and negative predictive values is not appropriate. Imaging studies and follow up subject scans will be organized so that a panel of independent readers will evaluate the MRI and PET studies to assess the level of suspicion for prostate cancer.

Study Design

Study Type:

Interventional

Actual Enrollment :

273 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

A Phase 2 Comparison Study of 68Ga-PSMA-HBED-CC Positron Emission Tomography (PET)/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

Actual Study Start Date :

Apr 3, 2018

Actual Primary Completion Date :

May 5, 2021

Actual Study Completion Date :

May 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET/MRI 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 Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical
Experimental: Multiple PET/MRI 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 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
Experimental: PET/CT 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.	Drug: PET/CT with Gallium-68 labeled PSMA-HBED-CC Subjects have one visit, during which they will undergo one PET/CT with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical

Arm

Intervention/Treatment

Experimental: PET/MRI

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

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

Experimental: Multiple PET/MRI

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

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

Experimental: PET/CT

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.

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

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

Outcome Measures

Primary Outcome Measures

Sensitivity and specificity, of 68Ga-PSMA-HBED-CC PET [Up to two time points (approx. 2 hours each) within 3 years or less]
Compare the diagnostic performance, presented as comparative sensitivity and specificity, of 68Ga-PSMA-HBED-CC PET versus conventional MRI in a population of patients with prostate cancer.

Secondary Outcome Measures

Safety of the 68Ga-PSMA-HBED-CC [Up to two time points (approx. 2 hours each) within 3 years or less]
To be assessed by tabulation of number of procedure-related adverse effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Male aged 21 years or older.
Ability to provide signed informed consent and willingness to comply with protocol requirements.
Pathologic confirmation of adenocarcinoma of the prostate gland or high clinical suspicion (PSA > 4 ng/mL, or PSA density > 0.15 ng/mL2, or PSA doubling time < 2 years).
Meet one of the following 5 criteria
Planned for surgical extirpation, which may or may not include lymph node dissection (high risk primary disease)
Planned for targeted biopsy of primary lesion
Conventional imaging equivocal or suggestive of prostate cancer metastasis/es
Planned focal therapy (with or without radiation therapy) with serial follow-up
Elevated PSA with no conventional imaging suggestive of metastatic or recurrent disease
1. If part of PET/MRI cohort, subject will undergo clinically indicated MRI imaging prior to treatment.

Or b. If part of PET/CT cohort, subject will have had clinically indicated MRI within 3 months prior to treatment.

Participants must agree to use an acceptable form of birth control throughout the study period. Participants must use condoms for a period of seven days after each injection, if engaged in sexual activity.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10021

Sponsors and Collaborators

Weill Medical College of Cornell University
Cancer Research & Treatment Fund, Inc

Investigators

Principal Investigator: John W. Babich, Ph.D., Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT03439033

Other Study ID Numbers:

1706018301

First Posted:

Feb 20, 2018

Last Update Posted:

Mar 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Weill Medical College of Cornell University

prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Edetic Acid

N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid

Study Results

No Results Posted as of Mar 11, 2022