Determination of Baseline Levels for Prostate Cancer-Derived Extracellular Vesicles Following Local Treatment of 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

ACTIVE_NOT_RECRUITING

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2026-12-01

Brief Summary

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

This study is being done to determine whether levels of prostate cancer derived extracellular vesicles from blood and urine specimens correlate with response to primary local treatment (surgery) in prostate cancer.

Related Clinical Trials

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

Glycosylation of Exosomes in Prostate and Urothelial Carcinoma

NCT04960956

Prostate Cancer Urothelial Carcinoma

TERMINATED

Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

NCT00455624

Prostate Cancer

COMPLETED

S9346A Blood Samples From Patients With Metastatic Prostate Cancer Previously Treated With Bicalutamide and Goserelin

NCT01120262

Prostate Cancer

COMPLETED

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

Gene Expression in Patients With Metastatic Prostate Cancer Receiving CYP-17 Inhibition Therapy

NCT01953640

Hormone-Resistant Prostate Cancer Metastatic Prostate Carcinoma Prostate Adenocarcinoma +1 more

ACTIVE_NOT_RECRUITING

Detailed Description

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

PRIMARY OBJECTIVES:

I. Determine the levels of prostate cancer-derived extracellular vesicles pre- and post-RP.

II. Determine the correlation between levels of prostate cancer-derived extracellular vesicles and PSA.

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 cohorts.

COHORT I (RADICAL PROSTATECTOMY): Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.

COHORT II (NEOADJUVANT): Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed.

COHORT III (NEGATIVE CONTROLS): Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.

Conditions

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

Prostate Carcinoma

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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

Observational (Cohort I)

Prostate cancer patients undergo blood and urine sample collection on study. Patients' medical records are also reviewed.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Observational (Cohort III)

Female urology clinic patients and female volunteers undergo blood and urine sample collection on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Observational (Cohort II)

Prostate cancer patients undergo blood and urine sample collection throughout the study. Patients' medical records are also reviewed.

No interventions assigned to this group

Interventions

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

Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* PROSTATE CANCER PATIENTS:

* Age 18+
* Able to give informed consent
* Patients with prostate cancer
* Patients treated with primary prostatectomy

* The focus will be on high-risk patients with at least one of either criterion:
* PSA \>= 20 ng/ml
* AND/OR Gleason \>= 8
* AND/OR clinical stage \>= T3
* FEMALE CONTROL PATIENTS:

* Age 18+
* Able to give informed consent

Exclusion Criteria

* PROSTATE CANCER PATIENTS:

* Unable or unwilling to provide informed consent
* Metastatic prostate cancer - defined evidence of metastatic disease on pre-procedural testing
* FEMALE CONTROL PATIENTS:

* Unable or unwilling to provide informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes