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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Physical exams, MRI scans, X-rays, Biopsies, Phone or video check-ins, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "They may have follow-up phone calls every few months."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects tissue, blood, and other samples to learn how changes in cells and genes cause prostate cancer to start or grow. It is for men ages 18 and older who have or may have prostate cancer. The findings could help researchers develop new treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with prostate cancer confirmed by a biopsy (a tissue sample test), or suspected prostate cancer.
  • Need and agree to tests, treatment, or follow-up care for prostate cancer.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Be able and willing to give informed consent, meaning you understand and agree to join.
  • Meet at least one of the following PSA, exam, scan, or family history conditions.
  • Have a PSA blood test level of at least 1.0 ng/ml at ages 30–49, or at least 2.5 ng/ml at age 50 or older. PSA is a protein made by the prostate.
  • Have an unusual finding on a rectal exam of the prostate or a prostate MRI scan.
  • Have a father or brother with prostate cancer, or a mother or sister with breast or ovarian cancer.

Who can't join

  • Have other health problems that would prevent tests or treatment for prostate cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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.

Study sites (1)

MD