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Precision-Based Genomics in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04706663
Recruitment Status : Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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....


Condition or disease
Prostate Cancer

Detailed Description:

Background:

  • Prostate cancer is the most common cancer and the second leading cause of death in males in the United States with an estimated 191,930 new cases and 33,330 deaths in 2020.
  • There has been progress in identifying established risk factors for the development of prostate cancer, including genetic predisposition. The study of the molecular genetics of prostate cancer has identified pathogenic variants, such as BRCA1 and BRCA2 (associated with hereditary breast and ovarian cancer syndrome), HOXB13 (associated with hereditary prostate cancer), and DNA mismatch repair (MMR) gene variants (MLH1, MSH2, MSH6, PMS2, and EPCAM) associated with Lynch syndrome.
  • While our understanding of molecular genetics continues to grow, there remains a need to identify additional germline and somatic mutations and alterations that may increase an individual s risk to develop prostate cancer and potentially the aggressiveness of the disease. In studying the following alterations in prostate cancer, in both localized and advanced stages, potential expanded molecular findings may lead to actionable therapeutic targets and biomarker development. A better understanding of molecular genetics in a longitudinal study of subjects with prostate cancer may be helpful for the design of future treatment studies, and to develop a better understanding of the natural history of the disease

Objectives:

  • To longitudinally evaluate subjects with prostate cancer with known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, and MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM to better understand the natural history of the disease.
  • To longitudinally evaluate subjects with tumor mutational burden-high (TMB-H) prostate cancer [greater than or equal to 10 mutations/megabase (mut/Mb)].

Eligibility:

  • 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, and MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high or be deemed an exceptional responder. NOTE: any platform for genomics testing is acceptable (research or CLIA-certified)
  • Age greater than or equal to 18 years old

Design:

  • This will be a long-term multi-center study to comprehensively study participants with prostate cancer.
  • Participants will provide clinical information (including medical history, clinical tests, imaging studies and reports, surgical pathology reports, genetic test results).
  • Since long-term follow-up of individuals with prostate cancer is a major feature of the study, local sites intend to maintain active contact with study subjects for as long as possible. Participants will be followed throughout the course of their illnesses, with particular attention to patterns of disease recurrence and progression, response to therapies and duration of responses.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Natural History Study of Precision-Based Genomics in Prostate Cancer
Estimated Study Start Date : January 27, 2021
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
Cohort 1
Subjects with histologically confirmed prostate cancer and genomic testing results
Cohort 2
Subjects with histologically confirmed prostate cancer who deemed to be an exceptional responder with or without genomic testing results



Primary Outcome Measures :
  1. natural history of prostate cancer with known germline and/or somatic variants [ Time Frame: ongoing ]
    clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival

  2. natural history of TMB-H prostate cancer [ Time Frame: ongoing ]
    clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary clinical
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, 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)]. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706663


Contacts
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Contact: Katherine O Lee-Wisdom, R.N. (240) 858-3525 katherine.lee-wisdom@nih.gov

Locations
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United States, California
University of California San Diego
La Jolla, California, United States, 92093
Contact: Rana McKay    858-657-7876    rmckay@health.ucsd.edu   
University of California at Los Angeles
Los Angeles, California, United States, 90095
Contact: Matthew Rettig    310-794-7700    mrettig@mednet.ucla.edu   
University of California San Francisco
San Francisco, California, United States, 94143
Contact: Eric Small    415-353-7095    Eric.Small@uscf.edu   
United States, Illinois
Lurie Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Contact: Maha Hussain    312-926-2413    mahahuss@med.umich.edu   
United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
United States, Massachusetts
Massachusetts General Hospital, Cancer Center
Boston, Massachusetts, United States, 02114
Contact: Xin Gao    617-724-4000    XGAO4@partners.org   
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact: Himisha Beltran    617-632-2429    himisha_beltran@dfci.harvard.edu   
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Arul Chinnaiyan    734-647-8903    arul@med.umich.edu   
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
Contact: William Oh    212-241-6756    William.Oh@mssm.edu   
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: Wassim Abida    646-422-4633    abidam@mskcc.org   
Weill Cornell Medicine
New York, New York, United States, 10065
Contact: Cora Sternberg    646-962-2072    cns9006@med.cornell.edu   
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Contact: Julie Graff    503-494-6594    graffj@ohsu.edu   
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Contact: Bruce Montgomery    206-598-0860    rbmontgo@uw.edu   
Spain
Vall d'Hebron Institute of Oncology
Barcelona, Spain, 08035
Contact: Joaquin Mateo    (932) -54-3450    jmateo@vhio.net   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William L Dahut, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04706663    
Other Study ID Numbers: 10000048
000048-C
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 11, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
germline variants
somatic variants
Genetic Predisposition
Molecular Genetics
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases