Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr
Recruiting · NCT05948657 · Interventional (participants receive a specific treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
PSMA-PET CT
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
- 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.
- Initial diagnosis of prostate cancer greater than 15 months.
Where it is running
4 locations listed across 3 US states.
- UCLA - Los Angeles, California, United States
- UCSF - San Francisco, California, United States
- Weill Cornell Medicine - New York Presbyterian Hospital - New York, New York, United States
- UH Cleveland Medical Center - Cleveland, Ohio, United States