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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

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.

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Peter A. Pinto, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 2-5952
10 CENTER DR
BETHESDA MD 20892
(240) 858-3700
pp173u@nih.gov

Karen Holcomb
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B2L324A
10 Center Drive
Bethesda, Maryland 20892
(240) 974-9026
karen.holcomb@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02594202

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