Recruiting
Phase 2

PyL

Sponsor:

Hoag Memorial Hospital Presbyterian

Code:

NCT04700332

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DCFPyL PET/CT

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT04700332

Start date

Feb 1, 2021

Status verified date

Jul, 2021

Completion date

Dec 15, 2022

Anticipated

Primary completion date

Jul 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

184 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

DCFPyL PET/CT

Prostate Membrane Specific Antigen-specific imaging

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Irvine, California, United States, 92618

Contacts

Principal Investigator:

Gary Ulaner, MD

More Information

Sponsor

Hoag Memorial Hospital Presbyterian

Last update posted

Jul 27, 2021

Last verified

Jul, 2021

Keywords

  • Prostate Cancer
  • DCFPyL PET/CT
  • Staging
  • Biochemical relapse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hoag Memorial Hospital Presbyterian on 2021-07-27.