NCT04700332

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

January 4, 2021

Last Update Submit

July 26, 2021

Conditions

Prostate Cancer

Keywords

Prostate CancerDCFPyL PET/CTStagingBiochemical relapse

Outcome Measures

Primary Outcomes (2)

  • Detection of unsuspected metastases in high risk prostate cancer

    Determine the rate of detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or radiation therapy.

    up to 4 weeks

  • Detection of unsuspected metastases in biochemically recurrent prostate cancer

    Determine the rate of detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, yet no evidence of disease on CT/bone scan.

    up to 4 weeks

Study Arms (2)

High risk prostate cancer

EXPERIMENTAL

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

Biochemically recurrent prostate cancer

EXPERIMENTAL

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

Interventions

DCFPyL PET/CTDRUG

Prostate Membrane Specific Antigen-specific imaging

Biochemically recurrent prostate cancerHigh risk prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Irvine, California, 92618, United States

RECRUITING

Related Publications (1)

  • Ulaner GA, Thomsen B, Bassett J, Torrey R, Cox C, Lin K, Patel T, Techasith T, Mauguen A, Rowe SP, Lindenberg L, Mena E, Choyke P, Yoshida J. 18F-DCFPyL PET/CT for Initially Diagnosed and Biochemically Recurrent Prostate Cancer: Prospective Trial with Pathologic Confirmation. Radiology. 2022 Nov;305(2):419-428. doi: 10.1148/radiol.220218. Epub 2022 Jul 19.

    PMID: 35852431DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Deborah Fridman, PsyD, RN

    Hoag Memorial Hospital Presbyterian

    STUDY DIRECTOR

Central Study Contacts

Beth Thomsen

CONTACT

949-764-4577clinicalresearch@hoag.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Molecular Imaging and Therapy

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 7, 2021

Study Start

February 1, 2021

Primary Completion

July 15, 2022

Study Completion

December 15, 2022

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)