Trial Title:
Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
NCT ID:
NCT05948657
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission
Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PSMA-PET CT
Description:
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission
Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
Arm group label:
PSMA-PET CT
Summary:
This study will be assessing the ability of PSMA-PET CT to determine the absence of
clinically significant prostate cancer in patients on active surveillance (AS) with low
risk and favorable intermediate-risk prostate cancer.
Detailed description:
This is a prospective, multicenter, nonrandomized single-arm study assessing the
diagnostic accuracy of PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission
Tomography-Computed Tomography) in determining the absence of clinically significant
prostate cancer in patients on active surveillance (AS).The trial will enroll 200
subjects for low and favorable intermediate-risk prostate cancer patients per NCCN
guidelines who have elected to pursue active surveillance.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Males aged ≥ 18.
- Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN
guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and
no presence of cribiform or intraductal carcinoma).
- PSA < 20 ng/ml.
- Ability to undergo yearly PSMA-PET CT.
- Ability to undergo yearly prostate mpMRI.
- Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
- Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
- Willingness to undergo yearly prostate biopsies.
Exclusion Criteria:
- History of prior treatment for prostate cancer.
- History of systemic therapy for prostate cancer.
- Inability to undergo transrectal ultrasound.
- Life expectancy less than 10 years.
- Not interested in pursuing active surveillance.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA
Address:
City:
Los Angeles
Zip:
90005
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Pragya Yadav
Phone:
646-962-2199
Investigator:
Last name:
Wayne Brisbane, M.D.
Email:
Principal Investigator
Facility:
Name:
UCSF
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Pragya Yadav
Phone:
646-962-2199
Email:
pry2003@med.cornell.edu
Investigator:
Last name:
Matthew Cooperberg, M.D.
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medicine - New York Presbyterian Hospital
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Timothy McClure, M.D.
Investigator:
Last name:
Timothy McClure, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Himanshu Nagar, M.D.
Email:
Principal Investigator
Facility:
Name:
Case Western University Hospitals
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Pragya Yadav
Phone:
646-962-2199
Email:
pry2003@med.cornell.edu
Investigator:
Last name:
Jonathan Shoag, M.D.
Email:
Principal Investigator
Facility:
Name:
UT Southwestern
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Pragya Yadav
Phone:
646-962-2196
Email:
pry2003@med.cornell.edu
Contact backup:
Last name:
Sharanya Chandrasekhar
Phone:
646-962-3110
Email:
shc2043@med.cornell.edu
Investigator:
Last name:
Solomon Woldu, M.D.
Email:
Principal Investigator
Start date:
February 26, 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Weill Medical College of Cornell University
Agency class:
Other
Source:
Weill Medical College of Cornell University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05948657
