Genetic Biomarker Discovery for Metastatic Prostate Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-007522
NCT ID: NCT03228810
Sponsor Protocol Number: 16-007522
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Cheville, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available