Trial Outcomes & Findings for The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer (NCT NCT04936334)

NCT ID: NCT04936334

Last Updated: 2023-08-03

Results Overview

Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.
• Results posted on: 2023-08-03

Participant Flow

Unit of analysis: Prostate lobes (right and left)

Participant milestones

Measure	PSMA-PET and MRI in Men Scheduled for Prostatectomy Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI. There were 100 prostate lobes examined with 2 lobes per patient.
Overall Study STARTED	51 102
Overall Study COMPLETED	50 100
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Measure	PSMA-PET and MRI in Men Scheduled for Prostatectomy Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI. There were 100 prostate lobes examined with 2 lobes per patient.
Overall Study Metastatic disease found on PSMA-PET, surgery cancelled	1

Baseline Characteristics

The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer

Baseline characteristics by cohort

Measure	PSMA-PET and MRI in Men Scheduled for Prostatectomy n=50 Participants Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI. There were 100 prostate lobes examined with 2 lobes per patient.
Age, Continuous	61.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
PSA	7.0 ng/mL n=5 Participants
Gleason Grade-group, final pathology Grade-Group 1 (Gleason)	1 participants n=5 Participants
Gleason Grade-group, final pathology Grade-Group 2 (Gleason)	15 participants n=5 Participants
Gleason Grade-group, final pathology Grade-Group 3 (Gleason)	15 participants n=5 Participants
Gleason Grade-group, final pathology Grade-Group 4 (Gleason)	9 participants n=5 Participants
Gleason Grade-group, final pathology Grade-Group 5	10 participants n=5 Participants
Pathologic stage (T) pT2	25 participants n=5 Participants
Pathologic stage (T) pT3a	12 participants n=5 Participants
Pathologic stage (T) pT3b	13 participants n=5 Participants
Pathologic stage (T) pT4	0 participants n=5 Participants
Pathologic stage (N)	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.

Population: Men diagnosed with prostate cancer often seek surgical treatment. Surgical treatment--radical prostatectomy--is currently guided by clinical parameters (PSA, pathology) and MRI imaging. These men often have considerable concerns about the balance of cancer control and quality of life after the surgery. There were 100 prostate lobes examined with 2 lobes per patient. One patient was enrolled but did not complete study procedures.

Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles

Outcome measures

Measure	PSMA-PET in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy n=100 prostate lobes Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery There were 100 prostate lobes examined with 2 lobes per patient.	MRI in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy n=100 prostate lobes Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo imaging with MRI in addition to PSMA-PET. There were 100 prostate lobes examined with 2 lobes per patient.
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension	86 percentage Interval 71.0 to 100.0	57 percentage Interval 36.0 to 78.0

PRIMARY outcome

Timeframe: Pre-surgery prediction.

Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.

Outcome measures

Measure	PSMA-PET in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy n=100 prostate lobes Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery There were 100 prostate lobes examined with 2 lobes per patient.	MRI in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy n=100 prostate lobes Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo imaging with MRI in addition to PSMA-PET. There were 100 prostate lobes examined with 2 lobes per patient.
Specificity of PSMA-PET and MRI	73 Percentage Interval 64.0 to 83.0	77 Percentage Interval 68.0 to 86.0

SECONDARY outcome

Timeframe: 60 Days

Rate of treatment changes

Outcome measures

Measure	PSMA-PET in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy n=50 Participants Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery There were 100 prostate lobes examined with 2 lobes per patient.	MRI in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo imaging with MRI in addition to PSMA-PET. There were 100 prostate lobes examined with 2 lobes per patient.
1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET	20 participants	—

Adverse Events

PSMA-PET and MRI in Men Scheduled for Prostatectomy

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

Jennifer Lehman, RN, Senior Research Leader

Indiana University, Department of Urology

Phone: 317-948-9575

Email: jgeck@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place