PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

Phase 2RecruitingNCT04700332

Hoag Memorial Hospital Presbyterian184 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

184

Conditions

Prostate Cancer

Interventions

DCFPyL PET/CTDRUG

Prostate Membrane Specific Antigen-specific imaging

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hoag Memorial Hospital Presbyterian

Irvine, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to 4 weeks

Central Contacts

Beth Thomsen

CONTACT

949-764-4577 clinicalresearch@hoag.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.