PSMA Imaging of Localized Prostate Cancer

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03675451
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 16.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The present study is a phase II, open label, single-center, non-randomized, single-dose study.

Twenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH.

The primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized, clinically significant (defined as: ≥ 0.5 cm3 with Gleason pattern ≥ 4) prostate cancer (PCa).

After the screening period (up to 28 days), each subject will be scheduled to receive 10 mg infusion of IAB2M conjugated with 2.5 mCi 89Zr-Df.

2 - 4 days post-infusion, subjects will undergo a 89Zr-Df-IAB2M PET/CT scan. Images read by a Nuc Med MD reporting: location, SUV and, if possible, size of all areas with abnormal uptake.

(they will also undergo a pelvic MRI if they have not obtained an MR image during the screening period or on day of infusion)

Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.

Patient will undergo radical prostatectomy after completion of above imaging procedures.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: 89ZR-DF-IAB2M; Drug: 68Ga-PSMA-HBED-CC	Phase 2

Detailed Description

The primary endpoint of this study is the proportion of subjects with PSMA-positive (identified by H&E staining and immunohistochemistry) "dominant" PC lesion(s) greater than 5mm in diameter, whose lesion(s) have been successfully identified by 89Zr-Df-IAB2M imaging. Because this is an exploratory pilot study, no formal sample size/power calculation is required. However, with a sample size of 20 patients in the study, a two-sided 95% confidence interval for the proportion of patients successfully imaged by 89Zr-Df-IAB2M can be constructed to be within ± 19.0% of the observed proportion of patients with successful imaging by 89Zr-Df-IAB2M. This calculation assumes an 89Zr-Df-IAB2M imaging-success proportion of 75%. All estimates from the study will serve as preliminary data (i.e., hypothesis-generating) for future studies.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: PSMA Imaging of Localized Prostate Cancer
• Actual Study Start Date: Feb 8, 2017
• Actual Primary Completion Date: Jun 27, 2018
• Actual Study Completion Date: Jun 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional Injection of study drug followed by PET/CT imaging. Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance. Followed by prostatectomy	Drug: 89ZR-DF-IAB2M; injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan; Drug: 68Ga-PSMA-HBED-CC; Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.

Outcome Measures

Primary Outcome Measures

1. The Number of Subjects With PSMA-positive (Prostate-specific Membrane Antigen) "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been Successfully Identified by 89Zr-df-IAB2M PET/CT [Up to 30 days pre-prostatectomy]

   The number of subjects whose lesions have been successfully identified through 89Zr-df-IAB2M PET/CT will be ascertained using a combination of the descriptive statistics and lesion-based analysis, which both utilize multiple measurements

2. The Number of Subjects With PSMA-positive "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been Successfully Identified by 68Ga-PSMA-HBED-CC PET/CT [Up to 30 days pre-prostatectomy]

   The number of subjects with PSMA-positive (prostate-specific membrane antigen) "dominant" PC lesion(s) greater than 5mm in diameter, whose lesion(s) have been successfully identified by 68Ga-PSMA-HBED-CC PET/CT

Secondary Outcome Measures

1. The Number of Clinically-significant Lesions Detected by 89Zr-df-IAb2M PET/CT [Up to 30 days pre-prostatectomy]

2. The Number of Clinically Significant Lesions Detected by 68Ga-PSMA-HBED-CC PET/CT [Up to 30 days pre-prostatectomy]

   Participants underwent 68Ga-PSMA-HBED-CC injection and PET/CT scan (1 to 3 hours after the injection),e performed prior to radical prostatectomy.

3. The Number of Clinically Significant Lesions Detected by mpMRI [Up to 30 days pre-prostatectomy]

   pre-prostatectomy standard of care mpMRI used to determine the number of clinically significant lesions

4. The Number of Clinically Significant Lesions Detected by mpMRI in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT [Up to 30 days pre-prostatectomy]

   The Number of Clinically Significant Lesions Detected by mpMRI in subjects who underwent 68Ga-PSMA-HBED-CC injection and PET/CT

5. The Number of Clinically Significant Lesions Detected by 89Zr-df-IAB2M PET/CT in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT [Up to 30 days pre-prostatectomy]

   The Number of clinically significant lesions detected by 89Zr-df-IAB2M PET/CT in the subset of subjects who underwent 68Ga-PSMA-HBED-CC Injection and PET/CT

6. The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT [Up to 30 days pre-prostatectomy]

7. The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT [Up to 30 days pre-prostatectomy]

8. The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT [Up to 30 days pre-prostatectomy]

9. The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT [Up to 30 days pre-prostatectomy]

10. The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography) [Up to 30 days pre-prostatectomy]

    All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events

11. The Number of Observed or Reported Treatment-Emergent Adverse Events Following 68Ga-PSMA-HBED-CC PET/CT [Up to 30 days pre-prostatectomy]

    All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed localized prostate cancer that are scheduled to undergo radical prostatectomy.

• Age >18 years.

• Patients must have laboratory values consistent with eligibility to undergo a radical prostatectomy:

• creatinine less than or equal to 1.5 X upper limit of normal

• creatinine clearance > 60 mL/min

• The effects of 89Zr-Df-IAB2M on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, 89Zr-Df-IAB2M PET/CT and the surgical resection used for the study evaluation.

• Transrectal prostate biopsy performed less than four weeks prior to 89Zr-Df-IAB2M administration.

• Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

• Principal Investigator: Douglas S Scherr, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 31, 2017

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03675451
• Other Study ID Numbers: 1311014489
• First Posted: Sep 18, 2018
• Last Update Posted: Oct 14, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Weill Medical College of Cornell University: PET/CT; Imaging; Nuclear Medicine
• Additional relevant MeSH terms: Prostatic Neoplasms; Gallium 68 PSMA-11

Study Results

Participant Flow

Arm/Group Title	Interventional
Arm/Group Description	Injection of study drug followed by PET/CT imaging. Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance. Followed by prostatectomy 89ZR-DF-IAB2M: injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan 68Ga-PSMA-HBED-CC: Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Interventional
Arm/Group Description	Injection of study drug followed by PET/CT imaging. Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance. Followed by prostatectomy 89ZR-DF-IAB2M: injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan 68Ga-PSMA-HBED-CC: Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 75%
>=65 years	5 25%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	20 100%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	The Number of Subjects With PSMA-positive (Prostate-specific Membrane Antigen) "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been Successfully Identified by 89Zr-df-IAB2M PET/CT
Description	The number of subjects whose lesions have been successfully identified through 89Zr-df-IAB2M PET/CT will be ascertained using a combination of the descriptive statistics and lesion-based analysis, which both utilize multiple measurements
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

19 of the 20 enrolled subjects were analyzed, as one of the 20 did not follow through with prostatectomy following 89Zr-df-IAB2M PET/CT, thus pathology is not available for 1 subject for this analysis.

Arm/Group Title	89Zr-Df-IAB2M, mpMRI, Prostatectomy
Arm/Group Description	19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy
Measure Participants	19
Count of Participants [Participants]	18 90%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	89Zr-Df-IAB2M, mpMRI, Prostatectomy
	Comments	Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.
	Type of Statistical Test	Other
	Comments	Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Proportion of Participants
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.74 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments	Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.

2. Primary Outcome

Title	The Number of Subjects With PSMA-positive "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been Successfully Identified by 68Ga-PSMA-HBED-CC PET/CT
Description	The number of subjects with PSMA-positive (prostate-specific membrane antigen) "dominant" PC lesion(s) greater than 5mm in diameter, whose lesion(s) have been successfully identified by 68Ga-PSMA-HBED-CC PET/CT
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

9 of the 20 enrolled subjects were analyzed, as only 9 subjects completed 68Ga-PSMA-HBED-CC PET/CT

Arm/Group Title	89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy
Arm/Group Description	A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC, followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
Measure Participants	9
Count of Participants [Participants]	9 45%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	89Zr-Df-IAB2M, mpMRI, Prostatectomy
	Comments	Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.
	Type of Statistical Test	Other
	Comments	Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Proportion of Participants
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.66 to 1.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.

3. Secondary Outcome

Title	The Number of Clinically-significant Lesions Detected by 89Zr-df-IAb2M PET/CT
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

19 of the 20 enrolled subjects were analyzed, as one of the 20 did not follow through with prostatectomy following study 89Zr-df-IAB2M PET/CT, thus pathology is not available.

Arm/Group Title	89Zr-Df-IAB2M, mpMRI, Prostatectomy
Arm/Group Description	19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy
Measure Participants	19
Number [Lesions]	22

4. Secondary Outcome

Title	The Number of Clinically Significant Lesions Detected by 68Ga-PSMA-HBED-CC PET/CT
Description	Participants underwent 68Ga-PSMA-HBED-CC injection and PET/CT scan (1 to 3 hours after the injection),e performed prior to radical prostatectomy.
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

9 of the 20 enrolled subjects were analyzed, as only 9 subjects completed 68Ga-PSMA-HBED-CC PET/CT

Arm/Group Title	89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy
Arm/Group Description	A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
Measure Participants	9
Number [Lesions]	10

5. Secondary Outcome

Title	The Number of Clinically Significant Lesions Detected by mpMRI
Description	pre-prostatectomy standard of care mpMRI used to determine the number of clinically significant lesions
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

19 of the 20 enrolled subjects were analyzed, as one of the 20 did not follow through with prostatectomy following study 89Zr-df-IAB2M PET/CT, thus pathology is not available.

Arm/Group Title	89Zr-Df-IAB2M, mpMRI, Prostatectomy
Arm/Group Description	19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy
Measure Participants	19
Number [Lesions]	18

6. Secondary Outcome

Title	The Number of Clinically Significant Lesions Detected by mpMRI in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT
Description	The Number of Clinically Significant Lesions Detected by mpMRI in subjects who underwent 68Ga-PSMA-HBED-CC injection and PET/CT
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

9 of the 20 enrolled subjects were analyzed, as only 9 subjects completed 68Ga-PSMA-HBED-CC PET/CT

Arm/Group Title	89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy
Arm/Group Description	A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC, followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
Measure Participants	9
Number [Lesions]	8

7. Secondary Outcome

Title	The Number of Clinically Significant Lesions Detected by 89Zr-df-IAB2M PET/CT in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT
Description	The Number of clinically significant lesions detected by 89Zr-df-IAB2M PET/CT in the subset of subjects who underwent 68Ga-PSMA-HBED-CC Injection and PET/CT
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

9 of the 20 enrolled subjects were analyzed, as only 9 subjects completed 68Ga-PSMA-HBED-CC PET/CT

Arm/Group Title	89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy
Arm/Group Description	A subset of 9 participants were injected with 68Ga-PSMA-HBED-CC (5±2mCi) followed by PET/CT imaging 1 to 3 hours after the injection. This preceded prostatectomy.
Measure Participants	9
Number [Lesions]	9

8. Secondary Outcome

Title	The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

20 Subjects were injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan. 19 of those 20 completed prostatectomy and have pathology available for analysis.

Arm/Group Title	89Zr-Df-IAB2M, mpMRI, Prostatectomy
Arm/Group Description	19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy
Measure Participants	19
Measure extra-prostatic lesions	12
Count of Units [extra-prostatic lesions]	9

9. Secondary Outcome

Title	The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC followed by PET/CT scan, prior to prostatectomy.

Arm/Group Title	89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy
Arm/Group Description	A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC, followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
Measure Participants	9
Measure extra-prostatic lesions	4
Count of Units [extra-prostatic lesions]	4

10. Secondary Outcome

Title	The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

19 of the 20 enrolled subjects were analyzed, as one of the 20 did not follow through with prostatectomy following study 89Zr-df-IAB2M PET/CT, thus pathology is not available.

Arm/Group Title	89Zr-Df-IAB2M, mpMRI, Prostatectomy
Arm/Group Description	19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
Measure Participants	19
Measure Occult Lymph Nodes	10
Count of Units [Occult Lymph Nodes]	7

11. Secondary Outcome

Title	The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

A subset of 9 of the 20 subjects were analyzed, as only 9 subjects completed 68Ga-PSMA-HBED-CC PET/CT. All 9 of those subjects had post-prostatectomy pathology for analysis.

Arm/Group Title	89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy
Arm/Group Description	A subset of 9 participants were injected with 68Ga-PSMA-HBED-CC followed by PET/CT imaging 1 to 3 hours after the injection. This preceded prostatectomy.
Measure Participants	9
Measure Occult Lymph Nodes	2
Count of Units [Occult Lymph Nodes]	2

12. Secondary Outcome

Title	The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography)
Description	All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

AEs were assessed for all 20 subjects who completed 89ZR-DF-IAB2M PET/CT.

Arm/Group Title	89Zr-Df-IAB2M, mpMRI
Arm/Group Description	20 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging. A subset of 19 subjects underwent prostatectomy following imaging A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
Measure Participants	20
Number [Adverse Events]	0

13. Secondary Outcome

Title	The Number of Observed or Reported Treatment-Emergent Adverse Events Following 68Ga-PSMA-HBED-CC PET/CT
Description	All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events
Time Frame	Up to 30 days pre-prostatectomy

Outcome Measure Data

Analysis Population Description

AEs were assessed for all 9 subjects who completed PET/CT.

Arm/Group Title	89Zr-Df-IAB2M, mpMRI
Arm/Group Description	20 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging. A subset of 19 subjects underwent prostatectomy following imaging A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.
Measure Participants	9
Number [Adverse Events]	0

Adverse Events

Time Frame	1 year, 6 months
Arm/Group Title	Interventional 89ZR-DF-IAB2M		68Ga-PSMA-HBED-CC (5±2mCi)
Arm/Group Description	89ZR-DF-IAB2M: injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan		Injection of 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
All Cause Mortality
	Interventional 89ZR-DF-IAB2M		68Ga-PSMA-HBED-CC (5±2mCi)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/9 (0%)
Serious Adverse Events
	Interventional 89ZR-DF-IAB2M		68Ga-PSMA-HBED-CC (5±2mCi)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Interventional 89ZR-DF-IAB2M		68Ga-PSMA-HBED-CC (5±2mCi)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.