Genetic Biomarker Discovery for Metastatic Prostate Cancer
Completed
- Conditions
- Prostate Cancer
- Interventions
- Other: Blood drawProcedure: Tissue biopsy
- Registration Number
- NCT03228810
- Lead Sponsor
- Mayo Clinic
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 4
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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Men >18 years old with metastatic prostate cancer Blood draw - Men >18 years old with metastatic prostate cancer Tissue biopsy -
- Primary Outcome Measures
Name Time Method Detect cell-free tumor DNA in patients with metastatic prostate cancer prior to treatment tissue biopsy
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States