NCT03228810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

July 23, 2017

Last Update Submit

May 7, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Detect cell-free tumor DNA in patients with metastatic prostate cancer

    tissue biopsy

    prior to treatment

  • 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

Study Arms (1)

Men >18 years old with metastatic prostate cancer

Other: Blood drawProcedure: Tissue biopsy

Interventions

Blood drawOTHER

(2) 10 mL tubes will be collected

Men >18 years old with metastatic prostate cancer
Tissue biopsyPROCEDURE

Tissue biopsy of metastatic tissue if undergoing clinical care-directed biopsy

Men >18 years old with metastatic prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with metastatic prostate cancer

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.

    PMID: 32203306DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 23, 2017

First Posted

July 25, 2017

Study Start

May 2, 2017

Primary Completion

April 9, 2019

Study Completion

April 9, 2019

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)