Genetic Biomarker Discovery for Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

ROR1751: Genetic Biomarker Discovery for Metastatic Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228810
• Other study ID #: 16-007522
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: April 9, 2019

Study information

• Verified date: May 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detect cell-free tumor DNA in patients with metastatic prostate cancer	tissue biopsy	prior to treatment
Primary	Calculate cell-free tumor DNA in relation to metastasis-directed radiation and androgen deprivation therapy (ADT)	blood draw	before and immediately after ADT and at 3 months and 6 months after radiation

External Links

•   Mayo Clinic Clinical Trials