Prostate Cancer
Conditions
Keywords
Prostate Cancer, DCFPyL PET/CT, Staging, Biochemical relapse
Brief summary
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.
Detailed description
This will be a phase II clinical trial to assess the clinical value of PyL for detection of disease in pateints with: 1. High risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and 2. Biochemically recurrent prostate cancer (arm 2) but without evidence of disease of standard of care imaging (CT of the chest/abdomen/pelvis and bone scan). In both cohorts, PyL PET/CT will be obtained and evaluated by a nuclear radiologist trained in novel PET radiotracers, including PyL. Lesions suspicious for disease of PyL that were unsuspected on standard of care imaging will be selected for biopsy for pathologic confirmation if feasible . Pathology will be used as the reference standard for confirming malignancy.
Interventions
DRUGDCFPyL PET/CT
Prostate Membrane Specific Antigen-specific imaging
Sponsors
Hoag Memorial Hospital Presbyterian
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male ≥ 18 years of age. 2. Histologically confirmed adenocarcinoma of the prostate 3. 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
1. 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. 2. 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. 3. Change in therapy since standard of care imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of unsuspected metastases in high risk prostate cancer | up to 4 weeks | Determine the rate of detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or radiation therapy. |
| Detection of unsuspected metastases in biochemically recurrent prostate cancer | up to 4 weeks | Determine the rate of detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, yet no evidence of disease on CT/bone scan. |
Countries
United States
Contacts
Primary ContactBeth Thomsen
Outcome results
None listed