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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

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

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

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

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring prostate cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept 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
1. Planned for surgical extirpation, which may or may not include lymph node dissection (high risk primary disease)
2. Planned for targeted biopsy of primary lesion
3. Conventional imaging equivocal or suggestive of prostate cancer metastasis/es
4. Planned focal therapy (with or without radiation therapy) with serial follow-up
5. Elevated PSA with no conventional imaging suggestive of metastatic or recurrent disease
a. 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

Sites / Locations

Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

PET/MRI

Multiple PET/MRI

PET/CT

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

True positive rates for detecting lesions between PSMA PET/MRI and MP MRI in various anatomical locations were compared, including prostate/prostatic bed, N1 lymph nodes, N2 lymph nodes, and osseous lesions. Other anatomical sites are other than bone, node, and prostate.

Full Information

NCT ID

NCT03439033

First Posted

February 13, 2018

Last Updated

February 15, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

Cancer Research & Treatment Fund, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03439033

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Terminated

Why Stopped

Study Drug was FDA approved Summer 2021

Study Start Date

April 3, 2018 (Actual)

Primary Completion Date

May 5, 2021 (Actual)

Study Completion Date

May 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Cancer Research & Treatment Fund, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

273 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PET/MRI

Arm Type

Experimental

Arm Description

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.

Arm Title

Multiple PET/MRI

Arm Type

Experimental

Arm Description

Arm Title

PET/CT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Description

Time Frame

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 Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 a. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Osborne, M.D., Ph.D.

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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