PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorHoag Memorial Hospital Presbyterian
About this trial
The standard of care imaging of prostate cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. PyL is a novel PET tracer designed to detect prostate specific membrane antigen (PSMA) expressed on prostate cancer cells. PyL PET/CT may provide improved evaluation of clinically significant metastases in patients with prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male ≥ 18 years of age.
Histologically confirmed adenocarcinoma of the prostate
Disqualifiers
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
Change in therapy since standard of care imaging
Trial design
Design model
Parallel
Treatments tested in this trial
DCFPyL PET/CT
DrugProstate Membrane Specific Antigen-specific imaging
Treatment groups
184 Participants
are divided into 2 treatment groupsGroup A: High risk prostate cancerExperimental treatment 1 intervention
Group B: Biochemically recurrent prostate cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection of unsuspected metastases in high risk prostate cancer
Determine the rate of detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or radiation therapy.
Time frame
up to 4 weeks2
Detection of unsuspected metastases in biochemically recurrent prostate cancer
Determine the rate of detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, yet no evidence of disease on CT/bone scan.
Time frame
up to 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov