Trial Outcomes & Findings for PSMA Imaging of Localized Prostate Cancer (NCT NCT03675451)

NCT ID: NCT03675451

Last Updated: 2020-10-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Up to 30 days pre-prostatectomy

Results posted on

2020-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	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 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 Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=20 Participants
Age, Categorical >=65 years	5 Participants n=20 Participants
Sex: Female, Male Female	0 Participants n=20 Participants
Sex: Female, Male Male	20 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants

PRIMARY outcome

Timeframe: Up to 30 days pre-prostatectomy

Population: 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.

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=19 Participants 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
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	18 Participants

PRIMARY outcome

Timeframe: Up to 30 days pre-prostatectomy

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

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=9 Participants 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
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	9 Participants

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

Population: 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.

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=19 Participants 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
The Number of Clinically-significant Lesions Detected by 89Zr-df-IAb2M PET/CT	22 Lesions

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

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

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=9 Participants 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
The Number of Clinically Significant Lesions Detected by 68Ga-PSMA-HBED-CC PET/CT	10 Lesions

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

Population: 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.

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=19 Participants 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
The Number of Clinically Significant Lesions Detected by mpMRI	18 Lesions

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

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

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=9 Participants 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
The Number of Clinically Significant Lesions Detected by mpMRI in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT	8 Lesions

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

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

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=9 Participants 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
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	9 Lesions

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

Population: 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.

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=12 extra-prostatic lesions 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
The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT	9 extra-prostatic lesions

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=4 extra-prostatic lesions 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
The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT	4 extra-prostatic lesions

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

Population: 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.

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=10 Occult Lymph Nodes 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
The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT	7 Occult Lymph Nodes

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

Population: 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.

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=2 Occult Lymph Nodes 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
The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT	2 Occult Lymph Nodes

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

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

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=20 Participants 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
The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography)	0 Adverse Events

SECONDARY outcome

Timeframe: Up to 30 days pre-prostatectomy

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

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

Outcome measures

Outcome measures
Measure	89Zr-Df-IAB2M, mpMRI, Prostatectomy n=9 Participants 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
The Number of Observed or Reported Treatment-Emergent Adverse Events Following 68Ga-PSMA-HBED-CC PET/CT	0 Adverse Events

Adverse Events

Interventional 89ZR-DF-IAB2M

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

68Ga-PSMA-HBED-CC (5±2mCi)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Junaid Niaz

Weill Cornell Medicine

Phone: 212.746.5793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place