Evaluation of a Blood Biomarker to Try and Distinguish Between the Presence or Absence of Aggressive 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

TERMINATED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-10

Study Completion Date

2019-02-28

Brief Summary

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

A Laboratory Study to Evaluate Urine and Blood Biomarkers That Can Distinguish Between the Presence or Absence of Aggressive Prostate Cancer

Related Clinical Trials

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

Plasma and Urine Samples From Patients With Hormone-Refractory Prostate Cancer Enrolled on Clinical Trials CALGB-9480 or CALGB-9583

NCT00898833

Prostate Cancer

TERMINATED

Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence

NCT02070575

Prostate Cancer

COMPLETED

Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy. ICORG 06-15

NCT00955435

Prostate Cancer

UNKNOWN

Molecular Characterization of CTCs and ctDNA in Blood and Plasma Samples From Patients With Metastatic and/or Hormone-Resistant Prostate Cancer

NCT02370355

Hormone-Resistant Prostate Cancer Metastatic Prostate Carcinoma

TERMINATED

High-Risk Metachronous Oligometastatic Prostate Cancer Trial

NCT06212583

Prostate Cancer Oligometastatic Disease

RECRUITING PHASE2

Detailed Description

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

The over-arching goal of this study is to evaluate if biomarkers within the blood or urine of men with localized prostate cancer can distinguish between those with indolent cancer, defined as Gleason Grade Groups 1 and 2 and those with more aggressive disease (Gleason Grade Groups 3, 4, and 5).

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.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

1. Patient has been diagnosed with Prostate Cancer and is planning on having a Radical Prostatectomy performed at the Global Robotics Institute.
2. Diagnostic PSA ≤ 20 ng/mL.
3. Pathology report from most recent positive biopsy, prior to Radical Prostatectomy, is available.
4. Ability to read and understand the informed consent form.
5. Patient must have signed informed consent form

Exclusion Criteria

1. Any of the following active therapies received: radiation, chemotherapy, biologic agents, surgery, local therapies including cryotherapy or HIFU.
2. Diagnostic PSA \> 20 ng/mL or missing PSA.
3. Patients who are unable or unwilling to provide informed consent.

Eligible Sex

MALE

Accepts Healthy Volunteers

No