PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PSMA PET/CT for Assessment of Recurrent Prostate Cancer

NCT02899312

Prostatic Neoplasms Prostate Cancer

ACTIVE_NOT_RECRUITING

Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

NCT02151760

Metastatic Prostate Cancer

COMPLETED PHASE1

Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer

NCT02420977

Advanced Prostate Cancer

COMPLETED EARLY_PHASE1

Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer.

NCT03497377

Metastatic Prostate Cancer

COMPLETED PHASE1

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

NCT03181867

Prostate Neoplasms Prostatic Cancer Prostate Cancer +2 more

ENROLLING_BY_INVITATION PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

DCFPyL PET/CT

Intervention Type DRUG

Prostate Membrane Specific Antigen-specific imaging

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.

Group Type EXPERIMENTAL

DCFPyL PET/CT

Intervention Type DRUG

Prostate Membrane Specific Antigen-specific imaging

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DCFPyL PET/CT

Prostate Membrane Specific Antigen-specific imaging

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No