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Genetic Biomarker Discovery for Metastatic Prostate Cancer

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03228810
Collaborator
(none)
4
Enrollment
1
Location
23.2
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: Blood draw
  • Procedure: Tissue biopsy

Study Design

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 :
Apr 9, 2019
Actual Study Completion Date :
Apr 9, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Detect cell-free tumor DNA in patients with metastatic prostate cancer [prior to treatment]

    tissue biopsy

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

    blood draw

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
John Cheville, PI, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03228810
Other Study ID Numbers:
  • 16-007522
First Posted:
Jul 25, 2017
Last Update Posted:
May 9, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of May 9, 2019