Clinical trial NCT03429244: PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
Official title: PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results helps inform treatment decisions.
Primary purpose: DIAGNOSTIC

Brief summary: 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 clinically significant prostate cancer lesion.

Secondary Objectives Evaluate how knowledge of the PSMA-PET might inform treatment planning.

Exploratory Objectives Generate pilot data for future larger clinical trials

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.

Primary outcomes:
measure: Diagnostic Accuracy of PSMA PET
timeFrame: 60 days
Secondary outcomes:
measure: Impact of PSMA PET-CT on Treatment Plan for Surgery or Biopsy
timeFrame: 60 days
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Indiana University Health North Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Clinton Bahler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bahler CD, Green MA, Tann MA, Swensson JK, Collins K, Alexoff D, Kung H, Brocken E, Mathias CJ, Cheng L, Hutchins GD, Koch MO. Assessing extra-prostatic extension for surgical guidance in prostate cancer: Comparing two PSMA-PET tracers with the standard-of-care. Urol Oncol. 2023 Jan;41(1):48.e1-48.e9. doi: 10.1016/j.urolonc.2022.10.003. Epub 2022 Nov 1.