Precision-Based Genomics in Prostate Cancer

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Sep 14, 2021

Status verified

Apr 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

2,000 participants (estimated)

Arms

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

Primary Outcome Measure

natural history of prostate cancer with known germline and/or somatic variants [ Time Frame: ongoing ]

Central Contacts

• Katherine O Lee-Wisdom, R.N.
  (240) 858-3525
  [email protected]
• Fatima H Karzai, M.D.
  (301) 480-7174
  [email protected]

Locations (11)

Find similar trials in La Jolla, CA

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