Description:
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of
68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer
lesions in low and intermediate risk disease.
A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system
(Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose
detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically
assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT
comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active
surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires
our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with
decades of experience and innovation.
Title
- Brief Title: PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
- Official Title: PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
IUSCC-0658
- SECONDARY ID:
1802085219
- NCT ID:
NCT03429244
Conditions
Purpose
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of
68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer
lesions in low and intermediate risk disease.
A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system
(Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose
detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically
assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT
comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active
surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires
our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with
decades of experience and innovation.
Detailed Description
This is a prospective, single arm, phase 2 clinical trial. This patient population will have
low (1 = Gleason 3 + 3) or intermediate risk (2 = 3 + 4; 3 = 4 + 3) prostate cancer. It will
also enroll those who are at high risk of significant prostate cancer (4Kscore >20%,
SelectMDx >20%, PSA density >0.15). Patients will be scheduled for magnetic resonance imaging
(MRI) as part of routine care for either surgical planning or for further biopsy. Following
the informed consent process, patients who enroll in the study will receive a PSMA positron
emission tomography (PET) study along with their standard of care (SOC) MRI on an integrated
PET-MRI. Registration of PET and MRI will be done using software to generate the PET-MRI
images. Patients receiving SOC MRI guided biopsy will receive additional PET guided biopsies
as indicated in a single session. The sensitivity and specificity will be evaluated along
with the ability of the tracer to inform the treatment planning. Patients receiving surgical
removal of the prostate will have a slice-by-slice whole mount analysis to assess the
sensitivity and specificity the PSMA PET.
Primary Objectives Define the accuracy of 68Ga-PSMA-11 PET-CT for detecting the location and
size of clinically significant prostate cancer lesions in low and intermediate risk disease.
Secondary Objectives Evaluate how knowledge of the PSMA-PET might inform treatment planning.
Exploratory Objectives Generate pilot data for future larger clinical trials
Trial Arms
Name | Type | Description | Interventions |
---|
Low and intermediate risk prostate cancer | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. ≥ 18 years of age
2. Must provide written informed consent
3. Presence of low or intermediate risk prostate cancer or at risk of having intermediate
risk cancer
a. Intermediate risk prostate cancer: i. Grade group 2 = 3 + 4, or ii. Grade group 3 =
4 + 3 b. At Risk of intermediate risk prostate cancer: i. 4K score ≥ 20%, or ii.
Select MDx ≥ 20%, or iii. PSA Density ≥ 0.15 iv. Grade group 1= 3+3 (iv. Note: Where
multiple cancer lesions are present on biopsy, it is allowable to have Gleason 8 or 9
cancer lesions if they are in addition to the intermediate risk cancer as described
above.)
4. Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further
biopsy, or surgical removal, or focal therapy.
5. Willing and able to lie still for approximately 50 minutes in an enclosed space for
the CT.
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 is not allowed).
3. Significant acute or chronic medical, neurologic, or psychiatric illness in the
subject that, in the judgment of the Principal Investigator, could compromise subject
safety, limit the subject's ability to complete the study, and/or compromise the
objectives of the study.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Diagnostic accuracy of mpMRI |
Time Frame: | 60 days |
Safety Issue: | |
Description: | Sextant-based analysis of sensitivity, specificity, and ROC using prostatectomy whole-mount analysis or biopsy pathology |
Secondary Outcome Measures
Measure: | Impact of PSMA PET-CT on treatment plan for surgery |
Time Frame: | 60 days |
Safety Issue: | |
Description: | Additional lesions found, additional sextants involved, extra-capsular extension detected, seminal vesicle invasion detected, lymph node invasion detected. |
Measure: | Impact of PSMA PET-CT on treatment plan for biopsy |
Time Frame: | 60 days |
Safety Issue: | |
Description: | Additional lesions found, additional sextants involved |
Measure: | For 3+4: Sensitivity and specificity of mpMRI based on Gleason percent pattern 4 |
Time Frame: | 60 days |
Safety Issue: | |
Description: | for surgery based cohort |
Measure: | For 3+4: Sensitivity and specificity of PET-CT based on Gleason percent pattern 4 |
Time Frame: | 60 days |
Safety Issue: | |
Description: | for surgery based cohort |
Measure: | Sensitivity and specificity for extra-capsular extension (mpMRI vs PET-CT) |
Time Frame: | 60 days |
Safety Issue: | |
Description: | for surgery cohort |
Measure: | Sensitivity and specificity for seminal vesicle invasion (mpMRI vs PET-CT) |
Time Frame: | 60 days |
Safety Issue: | |
Description: | for surgery cohort |
Measure: | Lesion based analysis of accurate |
Time Frame: | 60 days |
Safety Issue: | |
Description: | Lesion-based analysis using prostatectomy whole-mount analysis or biopsy pathology |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Indiana University |
Last Updated
October 9, 2020