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Completed

NCT Number: NCT03228810

Genetic Biomarker Discovery for Metastatic Prostate Cancer

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood Draw

Other

(2) 10 mL tubes will be collected

Tissue biopsy

Procedure

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

ROR1751: Genetic Biomarker Discovery for Metastatic Prostate Cancer

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2017
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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