PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04700332
• Other study ID #: 184-20-CA
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: July 2021
• Source: Hoag Memorial Hospital Presbyterian
• Contact: Beth Thomsen
• Phone: 949-764-4577
• Email: clinicalresearch[@]hoag.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Hoag Memorial Hospital Presbyterian	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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