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CompletedNCT03228810Updated May 9, 2019

Genetic Biomarker Discovery for Metastatic Prostate Cancer

An observational study in Prostate Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-09.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
4
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer

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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 4 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

Men with metastatic prostate cancer

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

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).
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
4 participants (actual)
Patient registry
No

Groups and cohorts

  • Men >18 years old with metastatic prostate cancer

    Other: Blood draw · Procedure: Tissue biopsy

Interventions

  • OtherBlood draw

    (2) 10 mL tubes will be collected

  • ProcedureTissue biopsy

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

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What researchers measure

Primary outcomes

  1. Detect cell-free tumor DNA in patients with metastatic prostate cancer

    tissue biopsy

    Time frame: prior to treatment

  2. Calculate cell-free tumor DNA in relation to metastasis-directed radiation and androgen deprivation therapy (ADT)

    blood draw

    Time frame: before and immediately after ADT and at 3 months and 6 months after radiation

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Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
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References and documents

Publications

  • 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. PubMed 32203306 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03228810
Lead sponsor
Mayo Clinic
Responsible party
John Cheville (PI, Mayo Clinic) — Principal investigator
First posted
Jul 25, 2017
Start date
May 2, 2017
Primary completion
Apr 9, 2019
Completion
Apr 9, 2019
Last update
May 9, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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