Protocol Details
Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
This study is currently recruiting participants.
Summary
Number | 16-C-0010 |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required | No |
Population Exclusion(s) | Adults who are or may become unable to consent;
Fetuses;
Female;
Children |
Keywords | Specimen Collection;
Carcinogenesis;
Prognostic Biomarkers;
Molecular Mechanims;
Cell Lines;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Prostate Cancer |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Cancer Institute |
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.
Eligibility
INCLUSION CRITERIA:
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. ECOG performance status of 0-2
3. Must be willing and able to provide informed consent
4. PSA > or equal to 1.0 ng/ml (for patients aged 30 - 49 years) OR
5. PSA > or equal to 2.5 ng/ml (for patients 50 years or older) OR
6. Abnormal DRE (i.e. enlarged, asymmetric, nodular, firm or tender) OR
7. Abnormal prostate MRI finding OR
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
EXCLUSION CRITERIA:
1. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT02594202