Prostate Cancer
Conditions
Brief summary
Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard). Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4). Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments. Assess quality of life changes from preoperative baseline.
Interventions
DIAGNOSTIC_TEST68Ga-PSMA-11 PET Scan
Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.
Sponsors
Clinton Bahler
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.
Intervention model description
68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with: 1. \> 3 cores of Gleason 3+4 or 2. NCCN unfavorable intermediate risk or 3. NCCN high-risk or 4. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months). Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI
Exclusion criteria
* 1\. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days. 2\. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging). 3\. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension | 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. | Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles |
| Specificity of PSMA-PET and MRI | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET | 60 Days | Rate of treatment changes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Metastatic disease found on PSMA-PET, surgery cancelled | 1 |
Baseline characteristics
| Characteristic | PSMA-PET and MRI in Men Scheduled for Prostatectomy |
|---|---|
| Age, Continuous | 61.5 years |
| Gleason Grade-group, final pathology Grade-Group 1 (Gleason) | 1 participants |
| Gleason Grade-group, final pathology Grade-Group 2 (Gleason) | 15 participants |
| Gleason Grade-group, final pathology Grade-Group 3 (Gleason) | 15 participants |
| Gleason Grade-group, final pathology Grade-Group 4 (Gleason) | 9 participants |
| Gleason Grade-group, final pathology Grade-Group 5 | 10 participants |
| Pathologic stage (N) | 8 Participants |
| Pathologic stage (T) pT2 | 25 participants |
| Pathologic stage (T) pT3a | 12 participants |
| Pathologic stage (T) pT3b | 13 participants |
| Pathologic stage (T) pT4 | 0 participants |
| PSA | 7.0 ng/mL |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSMA-PET in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy | Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension | 86 percentage |
| MRI in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy | Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension | 57 percentage |
p-value: <0.05McNemar
Primary
Specificity of PSMA-PET and MRI
Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.
Time frame: Pre-surgery prediction.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSMA-PET in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy | Specificity of PSMA-PET and MRI | 73 Percentage |
| MRI in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy | Specificity of PSMA-PET and MRI | 77 Percentage |
Secondary
1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET
Rate of treatment changes
Time frame: 60 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSMA-PET in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy | 1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET | 20 participants |