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PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04700332
Recruitment Status : Not yet recruiting
First Posted : January 7, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Gary Ulaner, Hoag Memorial Hospital Presbyterian

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: DCFPyL PET/CT Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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
Drug: DCFPyL PET/CT
Prostate Membrane Specific Antigen-specific imaging

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.
Drug: DCFPyL PET/CT
Prostate Membrane Specific Antigen-specific imaging




Primary Outcome Measures :
  1. Detection of unsuspected metastases in high risk prostate cancer [ Time Frame: 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.

  2. Detection of unsuspected metastases in biochemically recurrent prostate cancer [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700332


Contacts
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Contact: Beth Thomsen 949-764-4577 clinicalresearch@hoag.org

Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Investigators
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Study Director: Deborah Fridman, PsyD, RN Hoag Memorial Hospital Presbyterian
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Responsible Party: Gary Ulaner, Director Molecular Imaging and Therapy, Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier: NCT04700332    
Other Study ID Numbers: 184-20-CA
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gary Ulaner, Hoag Memorial Hospital Presbyterian:
Prostate Cancer
DCFPyL PET/CT
Staging
Biochemical relapse
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases