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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02594202
• Other study ID #: 160010
• Secondary ID: 16-C-0010
• Status: Recruiting
• Start date: December 21, 2015
• Est. completion date: January 1, 2027

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Karen Holcomb
• Phone: (240) 974-9026
• Email: karen.holcomb[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Objective:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer	Collection of blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue	Ongoing
Secondary	prostate cancer cell lines	Develop stable prostate cancer cell lines from procured tissue when feasible	ongoing
Secondary	Natural history of prostate cancer	Collect detailed history, pathologic data, perioperative findings, and treatment data to better characterize the natural and clinical histories of prostate cancer when feasible	ongoing
Secondary	Molecular profiling	whole genomic sequence characterizations, identification of specific mutations or single nucleotide polymorphisms (SNPs), comparative genomic hybridization, messenger and microRNA sequencing and expression, RNA Seq, DNA methylation (epigenetics), DNA copy number, and expression profiling	ongoing

External Links

•   NIH Clinical Center Detailed Web Page