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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000048-C

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;
Female;
Children

Keywords

germline variants;
somatic variants;
Genetic Predisposition;
Molecular Genetics;
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 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.

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Fatima H. Karzai, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240
10 CENTER DR
BETHESDA MD 20892
(301) 480-7174
fatima.karzai@nih.gov

Katherine O. Lee-Wisdom, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N240
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3525
katherine.lee-wisdom@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:

NCT04706663

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