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Trial Outcomes & Findings for PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer (NCT NCT03429244)

NCT ID: NCT03429244

Last Updated: 2023-05-08

Results Overview

Sensitivity and specificity for EPE using whole-mount analysis or biopsy pathology. EPE is extra-prostatic extension which means the cancer extends beyond the boundary of the prostate into adjacent muscle or fatty tissue.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

60 days

Results posted on

2023-05-08

Participant Flow

Participant milestones

Participant milestones
Measure
Prostate Cancer Being Treated With Radical Prostatectomy
68Ga-PSMA-11 PET: Patients will undergo injection of 68Ga-PSMA-11 and PET scanning followed by surgical resection. The PET scan will be used to predict cancer grade, location, and stage and compared to final pathology as reference standard.
Screening for Prostate Cancer or on Active Surveillance
This group gets PSMA-PET scan to help guide biopsy decision for initial diagnosis or active surveillance decisions.
Prostate Cancer Being Treated With Focal Therapy
This group gets PSMA-PET scan to help inform focal therapy treatment decisions (HIFU hemiablation).
Overall Study
STARTED
16
11
9
Overall Study
COMPLETED
14
10
8
Overall Study
NOT COMPLETED
2
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Prostate Cancer Being Treated With Radical Prostatectomy
68Ga-PSMA-11 PET: Patients will undergo injection of 68Ga-PSMA-11 and PET scanning followed by surgical resection. The PET scan will be used to predict cancer grade, location, and stage and compared to final pathology as reference standard.
Screening for Prostate Cancer or on Active Surveillance
This group gets PSMA-PET scan to help guide biopsy decision for initial diagnosis or active surveillance decisions.
Prostate Cancer Being Treated With Focal Therapy
This group gets PSMA-PET scan to help inform focal therapy treatment decisions (HIFU hemiablation).
Overall Study
Withdrawal by Subject
2
1
1

Baseline Characteristics

PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Prostate Cancer Being Treated With Radical Prostatectomy
n=14 Participants
68Ga-PSMA-11 PET: Patients will undergo injection of 68Ga-PSMA-11 and PET scanning followed by surgical resection. The PET scan will be used to predict cancer grade, location, and stage and compared to final pathology as reference standard.
Screening for Prostate Cancer or on Active Surveillance
n=10 Participants
This group gets PSMA-PET scan to help guide biopsy decision for initial diagnosis or active surveillance decisions.
Prostate Cancer Being Treated With Focal Therapy
n=8 Participants
This group gets PSMA-PET scan to help inform focal therapy treatment decisions (HIFU hemiablation).
Total
n=32 Participants
Total of all reporting groups
Age, Continuous
60.1 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
63.1 Years
STANDARD_DEVIATION 6.5 • n=7 Participants
66.5 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
62.6 Years
STANDARD_DEVIATION 7.4 • n=4 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
10 Participants
n=7 Participants
8 Participants
n=5 Participants
32 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
Race (NIH/OMB)
White
11 Participants
n=5 Participants
9 Participants
n=7 Participants
7 Participants
n=5 Participants
27 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
14 participants
n=5 Participants
10 participants
n=7 Participants
8 participants
n=5 Participants
32 participants
n=4 Participants
BMI
27.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
29.8 kg/m^2
STANDARD_DEVIATION 5.4 • n=7 Participants
29.8 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
28.7 kg/m^2
STANDARD_DEVIATION 5.2 • n=4 Participants

PRIMARY outcome

Timeframe: 60 days

Population: 13 patients in this arm had imaging followed by surgery. Each patient contributed 2 sides. This primary outcome is only available for this treatment arm as the reference standard is only available for this treatment arm. That is, the other 2 treatment arms did not undergo prostatectomy with pathological evaluation.

Sensitivity and specificity for EPE using whole-mount analysis or biopsy pathology. EPE is extra-prostatic extension which means the cancer extends beyond the boundary of the prostate into adjacent muscle or fatty tissue.

Outcome measures

Outcome measures
Measure
Prostate Cancer Being Treated With Radical Prostatectomy
n=26 Left and right nerve bundle
68Ga-PSMA-11 PET-MRI: Patients will undergo injection of 68Ga-PSMA-11 and PET scan followed by surgical resection.
Screening for Prostate Cancer or on Active Surveillance
This group gets PSMA-PET scan to help guide biopsy decision for initial diagnosis or active surveillance decisions.
Prostate Cancer Being Treated With Focal Therapy
This group gets PSMA-PET scan to help inform focal therapy treatment decisions (HIFU hemiablation).
Diagnostic Accuracy of PSMA PET
Sensitivity for EPE (%)
100 percentage
—
—
Diagnostic Accuracy of PSMA PET
Specificity for EPE (%)
74 percentage
—
—

SECONDARY outcome

Timeframe: 60 days

Population: Does the PET imaging help or inform or possibly help or inform the patient management?

Does the PSMA-PET change the treatment or biopsy decision. The surgeon will look at imaging prior to a procedure (prostatectomy, HIFU, or biopsy) to see if it informs the procedure steps. Does the imaging add new information about the cancer that could alter the biopsy or treatment? PSMA-PET scans were obtained in 3 different contexts as listed below (prior to prostate removal, screening for cancer or on active surveillance, and prior to focal therapy). We calculate the percentage of cases that had the treatment or followup plan altered by the investigational imaging agent. For example, if the PET imaging showed cancer was organ confined, then the surgeon may elect to increase the nerve sparing. For the active surveillance group, if this PET imaging showed a new lesion in the prostate, when compared to ultrasound or MRI, then the biopsy may have been altered to target this new lesion. For focal therapy, the treatment could be expanded to ensure any new PET lesions are covered.

Outcome measures

Outcome measures
Measure
Prostate Cancer Being Treated With Radical Prostatectomy
n=13 Participants
68Ga-PSMA-11 PET-MRI: Patients will undergo injection of 68Ga-PSMA-11 and PET scan followed by surgical resection.
Screening for Prostate Cancer or on Active Surveillance
n=10 Participants
This group gets PSMA-PET scan to help guide biopsy decision for initial diagnosis or active surveillance decisions.
Prostate Cancer Being Treated With Focal Therapy
n=8 Participants
This group gets PSMA-PET scan to help inform focal therapy treatment decisions (HIFU hemiablation).
Impact of PSMA PET-CT on Treatment Plan for Surgery or Biopsy
10 Participants
8 Participants
5 Participants

Adverse Events

Prostate Cancer Being Treated With Radical Prostatectomy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Screening for Prostate Cancer or on Active Surveillance

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Prostate Cancer Being Treated With Focal Therapy

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

Indianan University School of Medicine

Phone: 3179489575

Results disclosure agreements

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