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Precision-Based Genomics in Prostate Cancer

A Multi-Center Natural History Study of Precision-Based Genomics in Prostate Cancer

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 to 120 Years
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: Urine samples, Blood draws

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
  • "They may give blood and urine samples."
  • "Participants may be invited to NIH to give blood samples for research."
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 looks at gene changes in men with prostate cancer and how these changes relate to cancer growth and treatment results. It is for adult men who have certain gene changes or whose cancer has responded very well to treatment. Researchers will follow participants for life.

Background: Prostate cancer is the most common cancer and the second leading cause of death in males in the United States. Researchers want to find additional gene mutations that may increase a man s risk for prostate cancer and may affect how aggressive the disease is. Objective: To look at gene mutations in men with prostate cancer as well as the course of their disease to better understand how gene mutations relate to the way the cancer progresses and responds to treatment. Eligibility: Adult males 18 and older with prostate cancer who have at least one of the gene mutations researchers want to study and/or have been treated for their cancer and have had complete elimination of their cancer or stable disease for a long time. Design: Participants will be screened with a review of their medical records. Their gene test results will be reviewed, if available. They will be asked questions over the phone or in person. Participants do not need to visit the NIH for this study. But if they visit NIH for another study, their data and test results will be collected. They may give blood and urine samples. They may give leftover tumor samples. These samples will be used to study their genes. Participants who do not come to NIH on regular basis will be contacted every 6 months by phone or e-mail. They will be asked questions about their health. Data from their medical records will be collected. Participants will have testosterone and prostate-specific antigen (PSA) tests. Participants may be invited to NIH to give blood samples for research. Participants on this study will be followed for life....

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

Eligibility

Who can join

  • Be a man age 18 or older.
  • Have prostate cancer confirmed by testing a tissue sample.
  • Have certain gene changes or a high number of gene changes on testing, OR have had an unusually good response to cancer treatment.
  • Qualifying gene changes include those in PIK3, AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, the Wnt/B-catenin pathway, CDK12, MLH1, MSH2, MSH6, PMS2, or EPCAM. These may be inherited or found in cancer cells.
  • A high number of gene changes means at least 10 mutations per megabase on tumor testing or at least 16 on blood testing. A megabase is a measure of DNA length.
  • An unusually good treatment response means the cancer disappeared, clearly shrank, or responded for an unusually long time.
  • Be able to understand the study and be willing to sign a consent form.

Who can't join

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

    Official eligibility criteria

    * INCLUSION CRITERIA: * Subjects with histologically confirmed prostate cancer. * Must have known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, CDK12, and/or MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high(\[defined as greater than or equal to 10 mutations/megabase (mut/Mb) and/or bTMB \[greater than or equal to 16 mut/Mb\]. NOTE: any platform for genomics testing is acceptable (research or CLIA-certified) OR * be deemed an exceptional responder. NOTE: an exceptional response is defined as achievement of either a) a complete response, or b) a confirmed partial response in a trial or treatment or a response of exceptionally long duration * Age greater than or equal to 18 years old. * Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: -None

    Study sites (11)

    CA

    IL

    MA

    MD

    MI

    NY

    OR

    WA