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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

Tracking Information
First Submitted Date July 23, 2017
First Posted Date July 25, 2017
Last Update Posted Date May 9, 2019
Actual Study Start Date May 2, 2017
Actual Primary Completion Date April 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2017)
  • Detect cell-free tumor DNA in patients with metastatic prostate cancer [ Time Frame: prior to treatment ]
    tissue biopsy
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03228810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic Biomarker Discovery for Metastatic Prostate Cancer
Official Title ROR1751: Genetic Biomarker Discovery for Metastatic Prostate Cancer
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men with metastatic prostate cancer
Condition Prostate Cancer
Intervention
  • Other: Blood draw
    (2) 10 mL tubes will be collected
  • Procedure: Tissue biopsy
    Tissue biopsy of metastatic tissue if undergoing clinical care-directed biopsy
Study Groups/Cohorts Men >18 years old with metastatic prostate cancer
Interventions:
  • Other: Blood draw
  • Procedure: Tissue biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2019)
4
Original Estimated Enrollment
 (submitted: July 23, 2017)
10
Actual Study Completion Date April 9, 2019
Actual Primary Completion Date April 9, 2019   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03228810
Other Study ID Numbers 16-007522
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party John Cheville, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators Not Provided
PRS Account Mayo Clinic
Verification Date May 2019