Status:
RECRUITING
PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
Lead Sponsor:
Hoag Memorial Hospital Presbyterian
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 no...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04700332
Start Date
February 1 2021
End Date
December 15 2022
Last Update
July 27 2021
Active Locations (1)
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1
Hoag Memorial Hospital Presbyterian
Irvine, California, United States, 92618