Study of Molecular Circulatory Biomarkers in Hormone Sensitive and Castration Recurrent 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: 09-001889
Sponsor Protocol Number: MC0853
About this study
The purpose of this study is to collect blood and urine samples from men already diagnosed with advanced prostate cancer. The blood and urine specimens obtained from you and other participants during this research will be processed to look for proteins, protein products and genetic markers of cancer and its treatments that may have been shed in blood and urine specimens you volunteer to donate. These markers can potentially guide us to give specific treatments to the patients in future and also to develop "precision medicine". This way we increase the chance for the drugs to be effective and limit the toxicity of drugs typically used for treating advanced prostate cancers.
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:
- Subjects either with a histological confirmed diagnosis of prostate cancer or a history of previous prostate cancer specific treatment destined to initiate hormonal and/or chemotherapy treatments.
- This includes prostate cancer subjects with evidence of clinically biochemically progressive disease post surgical or radiation treatments for localized stage disease as deemed by the treating physician or after failure of androgen deprivation therapy. Biochemical evidence of progressive disease is defined as either as a serially rising PSA for two consecutive measurements, at least four weeks apart and clinical evidence for progression is defined as development of grossly metastatic disease as evidenced on clinical imaging scans performed as part of standard clinical care prior to enrollment.
- Age: 18 to 100 years
- Subject must be able to sign an informed consent.
- Informed consent must be signed at the time of enrollment and/or collection of any specimen and/or clinical data (other than PHI needed to screen and identify patients, which will be promptly discarded in a secure fashion if patient is not enrolled on study).
Exclusion Criteria:
- Subjects either incarcerated or with limited decision making capacity;
- Subjects clinically judged to be at increased risk of bleeding from phlebotomy;
- Subjects with hemoglobin ≤7gm%.
- Subjects with a previous history of known second non-GU malignancy in the past five years.
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 |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Winston Tan, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available