PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (PyL) in Patients With High Risk and Biochemically Recurrent Prostate Cancer
About This Trial
- This study is testing a new type of scan to see if it does a better job finding prostate cancer that has spread compared to standard imaging tests.
- It is designed for men with high-risk prostate cancer who are planning surgery or radiation, as well as men whose cancer may be returning based on rising PSA levels after past treatment.
- Before taking part, patients should know they must have had recent standard scans that did not clearly show the cancer, cannot have recently changed their cancer treatments, and must weigh under 450 pounds due to the scanner's weight limits.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing a new type of scan to see if it does a better job finding prostate cancer that has spread compared to standard imaging tests.
Study Details
- Start Date: February 1, 2021
- Lead Sponsor: Hoag Memorial Hospital Presbyterian
Full Eligibility Criteria
Inclusion Criteria
- Male ≥ 18 years of age.
- Histologically confirmed adenocarcinoma of the prostate
- Patients meet one of the follow criteria: Cohort 1: High risk prostate cancer (PSA >10, Gleason 8-10, or clinical stage >T2c) and planned prostatectomy or radiation therapy or Cohort 2: Biochemical prostate cancer relapse (Prostate Specific Antigen (PSA) > 0.2 ng/ml in patients following prostatectomy or ≥ 2 ng/ml more than the PSA nadir in patient following radiotherapy, as defined by the ASTRO-Phoenix criteria [18] and no evidence of malignancy on Standard of Care imaging for metastases (CT of the chest/abdomen/pelvis and bone scan) within 3 months.
Exclusion Criteria
- 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
Treatments
- Drug: DCFPyL PET/CT