NCT02964351

Brief Summary

In our study, the investigators want to find correlation between circulating miRNAs associated with prostate cancer metastases to bones and to lymph nodes separately with results of 68Ga-PSMA ligand PET (positron emission computed) imaging.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Status
unknown

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

First Submitted

Initial submission to the registry

November 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 8, 2016

Last Update Submit

November 15, 2016

Conditions

Prostate Carcinosarcoma

Keywords

MicroRNAProstate CarcinomaPET-MR

Outcome Measures

Primary Outcomes (1)

  • Metastasis size and location

    Location of metastasis by a report analyzing the pathological examination (PET-MR output).

    18 months

Secondary Outcomes (1)

  • MicroRNA profile by using Nano-string technology validated by real time PCR

    24 months

Study Arms (1)

High PSA (prostate-specific antigen) levels

Biological: High PSA levels

Interventions

High PSA levelsBIOLOGICAL
High PSA (prostate-specific antigen) levels

Eligibility Criteria

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

Patients with high PSA levels

You may qualify if:

  • Proven Adeno-carcinoma
  • Underwent prostatectomy and still present high PSA levels
  • Refered to PSMA exam.

You may not qualify if:

  • Below 18 years old
  • HIV/HBV (hepatitis B virus)/HCV (hepatitis C virus) positive
  • Additional malignancy during the past five years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Berindan-Neagoe I, Monroig Pdel C, Pasculli B, Calin GA. MicroRNAome genome: a treasure for cancer diagnosis and therapy. CA Cancer J Clin. 2014 Sep-Oct;64(5):311-36. doi: 10.3322/caac.21244. Epub 2014 Aug 7.

    PMID: 25104502BACKGROUND

  • Hovels AM, Heesakkers RA, Adang EM, Jager GJ, Strum S, Hoogeveen YL, Severens JL, Barentsz JO. The diagnostic accuracy of CT and MRI in the staging of pelvic lymph nodes in patients with prostate cancer: a meta-analysis. Clin Radiol. 2008 Apr;63(4):387-95. doi: 10.1016/j.crad.2007.05.022. Epub 2008 Feb 4.

    PMID: 18325358BACKGROUND

  • Briganti A, Abdollah F, Nini A, Suardi N, Gallina A, Capitanio U, Bianchi M, Tutolo M, Passoni NM, Salonia A, Colombo R, Freschi M, Rigatti P, Montorsi F. Performance characteristics of computed tomography in detecting lymph node metastases in contemporary patients with prostate cancer treated with extended pelvic lymph node dissection. Eur Urol. 2012 Jun;61(6):1132-8. doi: 10.1016/j.eururo.2011.11.008. Epub 2011 Nov 12.

    PMID: 22099610BACKGROUND

  • Weilbaecher KN, Guise TA, McCauley LK. Cancer to bone: a fatal attraction. Nat Rev Cancer. 2011 Jun;11(6):411-25. doi: 10.1038/nrc3055. Epub 2011 May 19.

    PMID: 21593787BACKGROUND

  • Logothetis CJ, Lin SH. Osteoblasts in prostate cancer metastasis to bone. Nat Rev Cancer. 2005 Jan;5(1):21-8. doi: 10.1038/nrc1528.

    PMID: 15630412BACKGROUND

  • Afshar-Oromieh A, Zechmann CM, Malcher A, Eder M, Eisenhut M, Linhart HG, Holland-Letz T, Hadaschik BA, Giesel FL, Debus J, Haberkorn U. Comparison of PET imaging with a (68)Ga-labelled PSMA ligand and (18)F-choline-based PET/CT for the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2014 Jan;41(1):11-20. doi: 10.1007/s00259-013-2525-5. Epub 2013 Sep 27.

    PMID: 24072344BACKGROUND

  • Schmid DT, John H, Zweifel R, Cservenyak T, Westera G, Goerres GW, von Schulthess GK, Hany TF. Fluorocholine PET/CT in patients with prostate cancer: initial experience. Radiology. 2005 May;235(2):623-8. doi: 10.1148/radiol.2352040494.

    PMID: 15858102BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

MicroRNA

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Natalia Goldberg, MD

    Assuta Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Goldberg, MD

CONTACT

972547833789natalia.goldberg@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 16, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 16, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share