Genetic Biomarker Discovery for Metastatic Prostate Cancer

NCT ID: NCT03228810

Last Updated: 2019-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-02

Study Completion Date

2019-04-09

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Men >18 years old with metastatic prostate cancer

Blood draw

Intervention Type OTHER

(2) 10 mL tubes will be collected

Tissue biopsy

Intervention Type PROCEDURE

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

Interventions

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Blood draw

(2) 10 mL tubes will be collected

Intervention Type OTHER

Tissue biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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John Cheville

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.

Reference Type DERIVED
PMID: 32203306 (View on PubMed)

Related Links

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Other Identifiers

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16-007522

Identifier Type: -

Identifier Source: org_study_id

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