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Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue

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ClinicalTrials.gov Identifier: NCT02594202
Recruitment Status : Recruiting
First Posted : November 3, 2015
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want to study blood, tissue, and fluid samples of people with prostate cancer. This will help them understand any changes in cells and genes. These changes might lead to the development and progression of prostate cancer. Researchers think the study could lead to new treatments.

Objective:

To understand the changes in cells and genes that lead to the development and progression of prostate cancer. This could lead to new treatments.

Eligibility:

Men ages 18 and older who have or are suspected to have prostate cancer

Design:

Participants will be screened with physical exam and medical history.

Participants will send tissue blocks of their tumor, if possible. If not, they will provide unstained slides of tumor tissue.

Participants may provide samples of blood, urine, saliva, and prostate secretions.

Participants may have imaging tests. They will lie in a machine that takes pictures of their body. These tests include:

MRI of the prostate

CT of the abdomen and pelvis

Chest x-ray

Participants may need a biopsy or surgery for treatment of their cancer. If so, researchers will collect tissue.

Participants may answer questions about their prostate cancer and quality of life.

Participants may have follow-up visits or other treatments. They may have follow-up phone calls every few months.


Condition or disease
Prostate Cancer

Detailed Description:

Background:

  • Prostate carcinoma is the second most common malignancy diagnosed in men. Approximately 1 in 6 men will be diagnosed with prostate cancer in their lifetime.
  • Understanding the molecular mechanisms and genomic alterations that cause prostate carcinoma will provide the foundation for the development of novel targeted therapeutic agents for this disease. Since 1982 investigators in the Urologic Oncology Branch have been studying the genetic basis of urologic cancers. The identification of the genes for cancer of the kidney has led to the approval by the FDA of a number of new agents for patients with advanced disease. Similarly, it is our goal to study the cancer biology (genomic, molecular, and cellular biology) of prostate carcinoma in order to develop novel treatment strategies.
  • Collection of patient tumor samples allows us to study molecular and biologic pathways and develop novel targeted therapies. Correlation of these samples with radiographical findings and clinical outcomes in patients allows us to predict and understand clinical outcomes and possibly develop predictive and/or prognostic biomarkers.

Objectives:

Primary: Collect blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue from patients with known or suspected prostate cancer for the purpose of elucidating the molecular mechanisms of carcinogenesis in prostate cancer and ultimately, identifying novel therapeutic targets.

Eligibility:

- Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or followup/ surveillance for their neoplasm.

Design:

  • Tissue acquisition protocol in which normal and malignant prostate cancer tissues may be obtained at the time of clinically indicated diagnostic and/or therapeutic intervention.
  • Blood and urine samples for research will be obtained at baseline and follow-up intervals. Expressed prostatic secretions may be collected at baseline and follow-up intervals. Additionally, saliva may be collected at baseline.
  • No investigational or experimental therapy will be given as part of this protocol.

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
Study Start Date : October 31, 2015
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
1
Adults (greater than or equal to 18 years of age) with biopsy-proven or suspected prostate cancer



Primary Outcome Measures :
  1. Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer [ Time Frame: Ongoing ]
    Collection of blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
Criteria
  • INCLUSION CRITERIA:
  • Adults (greater than or equal to 18 years of age) with biopsy-proven or suspected prostate cancer (elevated PSA or abnormal digital rectal exam (DRE)) who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
  • ECOG performance status of 0-2
  • Must be willing and able to provide informed consent

EXCLUSION CRITERIA:

-Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594202


Contacts
Contact: Michele L Diffenderfer, R.N. (240) 760-6121 michele.diffenderfer@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter A Pinto, M.D. National Cancer Institute (NCI)

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02594202     History of Changes
Other Study ID Numbers: 160010
16-C-0010
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 4, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Specimen Collection
Carcinogenesis
Prognostic Biomarkers
Molecular Mechanims
Cell Lines

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases