RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-12-21
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02594202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults (greater than or equal to 18 years of age) with biopsy-proven or suspected prostate cancer (elevated PSA abnormal digital rectal exam (DRE) abnormal prostate MRI, or family history) 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.
  2. 2. ECOG performance status of 0-2
  3. 3. Must be willing and able to provide informed consent
  4. 4. PSA \> or equal to 1.0 ng/ml (for patients aged 30 - 49 years) OR
  5. 5. PSA \> or equal to 2.5 ng/ml (for patients 50 years or older) OR
  6. 6. Abnormal DRE (i.e. enlarged, asymmetric, nodular, firm or tender) OR
  7. 7. Abnormal prostate MRI finding OR
  8. 8. Family history of first degree relatives (brother or father) with prostate cancer or first-degree relatives (mother or sister) with breast or ovarian cancer
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Karen K Holcomb
CONTACT
(240) 974-9026
karen.holcomb@nih.gov
Peter A Pinto, M.D.
CONTACT
(240) 858-3700
pp173u@nih.gov

Principal Investigator

Peter A Pinto, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Peter A Pinto, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-12-21
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2015-12-21
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • Specimen Collection
  • Carcinogenesis
  • Prognostic Biomarkers
  • Molecular Mechanims
  • Cell Lines
  • Natural History

Additional Relevant MeSH Terms

  • Prostate Cancer