Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 10/11/2018 |
| Start Date: | October 31, 2015 |
| End Date: | January 1, 2027 |
| Contact: | Michele L Diffenderfer, R.N. |
| Email: | michele.diffenderfer@nih.gov |
| Phone: | (240) 760-6121 |
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.
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.
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.
- 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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 888-624-1937
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