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Genetic Biomarker Discovery for Metastatic 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03228810
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
John Cheville, Mayo Clinic

Brief Summary:
Biomarkers from circulating cell-free tumor DNA in peripheral blood will identify patients with metastatic prostate cancer diagnosed with C11 choline PET/CT who will benefit from metastasis-directed radiation, ablative therapies, and/or surgery. Tissue and blood will be collected before treatment. If patients receive androgen deprivation, then blood will be collected after neoadjuvant androgen deprivation but before radiation, ablative therapies, or surgery. Subsequent samples will be obtained at 3 months and 6 months following treatment, after which no further patient contact will occur.

Condition or disease Intervention/treatment
Prostate Cancer Other: Blood draw Procedure: Tissue biopsy

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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ROR1751: Genetic Biomarker Discovery for Metastatic Prostate Cancer
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : April 9, 2019
Actual Study Completion Date : April 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Men >18 years old with metastatic prostate cancer Other: Blood draw
(2) 10 mL tubes will be collected

Procedure: Tissue biopsy
Tissue biopsy of metastatic tissue if undergoing clinical care-directed biopsy




Primary Outcome Measures :
  1. Detect cell-free tumor DNA in patients with metastatic prostate cancer [ Time Frame: prior to treatment ]
    tissue biopsy

  2. Calculate cell-free tumor DNA in relation to metastasis-directed radiation and androgen deprivation therapy (ADT) [ Time Frame: before and immediately after ADT and at 3 months and 6 months after radiation ]
    blood draw



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Sampling Method:   Non-Probability Sample
Study Population
Men with metastatic prostate cancer
Criteria

Inclusion Criteria:

  • Men age 18 years old and older.
  • Histologically proven diagnosis of prostate cancer.
  • Radiographic evidence of non-regional lymph node involvement, pelvic lymph node recurrence, and/or bone metastases.
  • Requiring a clinically directed biopsy or resection of tumor at Mayo Clinic Rochester.
  • Receiving local therapy for metastatic disease with radiation, ablative therapies, and/or surgery at Mayo Clinic Rochester.
  • Willingness to provide blood sample prior to receipt of treatment, as well as after neoadjuvant androgen deprivation therapy and at 3 months and 6 months after radiation, ablation, or surgery.
  • Absence of a second active malignancy.
  • An understanding of the protocol and its requirements, risks, and discomforts.
  • The ability and willingness to sign an informed consent.

Exclusion Criteria:

  • Inability on the part of the patient to understand the informed consent or be compliant with the protocol.
  • History of a serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).

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): NCT03228810


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic

Additional Information:
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Responsible Party: John Cheville, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03228810     History of Changes
Other Study ID Numbers: 16-007522
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases