PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

Part of paid clinical trials in Irvine, California.

Sponsor
Hoag Memorial Hospital Presbyterian
Study ID
NCT04700332
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DCFPyL PET/CT — DRUG
    Prostate Membrane Specific Antigen-specific imaging

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Jul 2021
Primary completion
Jul 15, 2022
Completion
Dec 15, 2022

Study Design

Enrollment
184 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: High risk prostate cancer
    DCFPyL PET/CT will be compared to CT/bone scan for detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or or radiation therapy
  • Experimental: Biochemically recurrent prostate cancer
    DCFPyL PET/CT will be utilized for detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, but with no evidence of disease on CT/bone scan.

Primary Outcome Measure

Detection of unsuspected metastases in high risk prostate cancer [ Time Frame: up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianIrvineCalifornia92618
Beth Thomsen
[email protected]
Gary Ulaner, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Hoag Memorial Hospital Presbyterian· Irvine, CA

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