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PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

DCFPyL PET/CT

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, DCFPyL PET/CT, Staging, Biochemical relapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Hoag Memorial Hospital PresbyterianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

High risk prostate cancer

Biochemically recurrent prostate cancer

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04700332

First Posted

January 4, 2021

Last Updated

July 26, 2021

Sponsor

Hoag Memorial Hospital Presbyterian

1. Study Identification

Unique Protocol Identification Number

NCT04700332

Brief Title

PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

July 15, 2022 (Anticipated)

Study Completion Date

December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hoag Memorial Hospital Presbyterian

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This will be a phase II clinical trial to assess the clinical value of PyL for detection of disease in pateints with: High risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High risk prostate cancer

Arm Type

Experimental

Arm Description

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

Arm Title

Biochemically recurrent prostate cancer

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

DCFPyL PET/CT

Intervention Description

Prostate Membrane Specific Antigen-specific imaging

Primary Outcome Measure Information:

Title

Detection of unsuspected metastases in high risk prostate cancer

Description

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

Time Frame

up to 4 weeks

Title

Detection of unsuspected metastases in biochemically recurrent prostate cancer

Description

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

Time Frame

up to 4 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beth Thomsen

Phone

949-764-4577

clinicalresearch@hoag.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah Fridman, PsyD, RN

Organizational Affiliation

Hoag Memorial Hospital Presbyterian

Official's Role

Study Director

Facility Information:

Facility Name

Hoag Memorial Hospital Presbyterian

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beth Thomsen

beth.thomsen@hoag.org

First Name & Middle Initial & Last Name & Degree

Gary Ulaner, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35852431

Citation

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.

Results Reference

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PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

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