Prostate CancerPhase 2NCT03439033

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

A Phase 2 study testing PET/MRI with Gallium-68 labeled PSMA-HBED-CC, Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC and PET/CT with Gallium-68 labeled PSMA-HBED-CC in people with Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: PET/MRI with Gallium-68 labeled PSMA-HBED-CC, Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC and PET/CT with Gallium-68 labeled PSMA-HBED-CC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 273 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2018to 5 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medical College
New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Prostate Cancer
Being tested: 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
Keywords: prostate cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03439033
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: PET/CT with Gallium-68 labeled PSMA-HBED-CC

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 20185 May 2021

First posted20 Feb 2018
Study start3 Apr 2018
Primary completion5 May 2021
Study completion5 May 2021

Why it stopped: Study Drug was FDA approved Summer 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
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)
Enrolment: 273 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03439033
Sponsor's protocol ID: 1706018301
Status last verified: Feb 2023
First submitted: 13 Feb 2018
Last updated: 13 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03439033
Acronym / sponsor ID: 1706018301
Conditions: Prostate Cancer
Keywords: prostate cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study Drug was FDA approved Summer 2021
Enrolment: 273 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Cancer Research & Treatment Fund, Inc.
Study start: 3 Apr 2018 (actual)
Primary completion: 5 May 2021 (actual)
Study completion: 5 May 2021 (actual)
First posted: 20 Feb 2018 (actual)
Results: Posted 13 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Subjects may be assigned to one of three groups, each with a different intervention in terms of either mode or frequency

Arm	Type	Receives
PET/MRI	Experimental	Drug: PET/MRI with Gallium-68 labeled PSMA-HBED-CCPET/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	Experimental	Drug: Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CCMultiple 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	Experimental	Drug: PET/CT with Gallium-68 labeled PSMA-HBED-CCPET/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.

Who may qualify

Ages: 21 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PET/MRI with Gallium-68 labeled PSMA-HBED-CCSubjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical	Drug	PET/MRI
Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CCSubjects 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	Drug	Multiple PET/MRI
PET/CT with Gallium-68 labeled PSMA-HBED-CCSubjects have one visit, during which they will undergo one PET/CT with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical	Drug	PET/CT

Primary outcome

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

1 secondary outcome

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
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

Results and safety

Results posted to the registry on 13 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PSMA PET/MRI Scan vs. MRI Scan	273	109

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

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. Count of participants. Unit: Participants

Measure	PSMA PET/MRI and PET/CT Scan n = 109	MRI Scan n = 109
Value	63	37

Primary outcome: 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

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. Number. Unit: lesions

Measure	PSMA PET/MRI and PET/CT Scan n = 109	MRI Scan n = 109
Total Number of Lesions	92	47
PSA Levels 0 to < 0.2 ng/mL	10	0
PSA Levels 0.2 to < 0.5 ng/mL	22	19
PSA Levels 0.5 to 2.0 ng/mL	25	10
PET/MRI: PSA Levels > 2.0 ng/mL	35	18

PSMA PET/MRI and PET/CT Scan vs MRI Scan: Risk Difference (RD): 0.42 (95% CI 0.30 to 0.53), p <0.0001, McNemar

Population analysed: Overall number of participants analyzed includes all participants who underwent MRI regardless of whether a pathologic lesion was identified.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected after each visit (approximately 1-3 hours), immediately post-scan and up to 2 years post-scan.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PSMA PET/MRI Scan	0 of 273 (0%)	0 of 273 (0%)	0 of 273
MRI Scan	0 of 273 (0%)	0 of 273 (0%)	0 of 273
PSMA PET/CT	0 of 1 (0%)	0 of 1 (0%)	0 of 1
PSMA Multiple PET/MRI	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph Osborne, M.D., Ph.D. principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Pathologic Lesions Detected by PSMA PET and PET/CT Compared to MP MRI (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03439033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.