microRNA Profiles Identification in Adeno Carcinoma Prostate Cancer

Prostate Carcinosarcoma Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02964351
• Other study ID #: 0093-16-ASMC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 8, 2016
• Last updated: November 15, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Assuta Medical Center
• Contact: Natalia Goldberg, MD
• Phone: 972547833789
• Email: natalia.goldberg[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Proven Adeno-carcinoma

• Underwent prostatectomy and still present high PSA levels

• Refered to PSMA exam.

Exclusion Criteria:

• Below 18 years old

• HIV/HBV (hepatitis B virus)/HCV (hepatitis C virus) positive

• Additional malignancy during the past five years.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinosarcoma
• Mixed Tumor, Mullerian
• Prostate Carcinosarcoma

Intervention

Biological:
• High PSA levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Medical Center

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Hövels 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. Review. — View Citation

Logothetis CJ, Lin SH. Osteoblasts in prostate cancer metastasis to bone. Nat Rev Cancer. 2005 Jan;5(1):21-8. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastasis size and location	Location of metastasis by a report analyzing the pathological examination (PET-MR output).	18 months	No
Secondary	MicroRNA profile by using Nano-string technology validated by real time PCR	Validation of MicroRNA pattern by using real time PCR	24 months	No