Clinical Value of FEC-PET Combined With Endorectal MRI for Pre-therapeutic Staging of Prostate Cancer

NCT00520546 | Completed Phase 3 Results DMC

• 2 other identifiers: 12K3-S-1407082006-003933-33
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the sensitivity of the \[18F\]fluoroethylcholine (FEC) Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) method in tumour detection and location (side assignment, encapsulation, invasion of the seminal vesicle) and detection of affected lymph nodes, and to compare these with presently used detection procedures (needle biopsy, digital rectal examination, transrectal ultrasound, and pre-therapeutic assessment), with a view to finding out whether the \[18F\]fluoroethylcholine PET/MRI method is comparable to, or superior to, the established method. Postoperative histology served as the standard of reference.

Conditions

Prostate Cancer

Keywords

PET; MRI; Choline; FEC; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Positive or Negative Results in PET, MRI or PET/MRI for Prostate Cancer Compared to Histological Findings

  PET positive lesions were measured on its own and evaluated as malignant just as hypointense lesions on MRI. In PET/MRI analysis, MRI suspect lesions without FEC uptake were considered not to be malignant. PET positive lesions in central periurethral zone with inhomogenous signal intensity and sharp edges on MRI images were also considered to be benign. PET positive lesions in the peripheral zone without a hypointense correlate on MRI were considered to be malignant. At least 1 histological confirmed cancer lesion has to be detected by each of the 3 methods to be patient based true positive.

  within < 2 weeks after PET/MRI

Secondary Outcomes (3)

• Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in All Patients

  within < 2 weeks after PET/MRI

• Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Gleason Score >6 (3+3)

  within < 2 weeks after PET/MRI

• Lesion Based Analysis of FEC-PET, Endorectal MRI and Combined FEC-PET/eMRI in Patients With Malignant Lesions >5mm (n=98)

  within < 2 weeks after PET/MRI

Study Arms (1)

1

EXPERIMENTAL

Patients with prostate carcinoma confirmed by needle biopsy, age \>50 years, planned radical prostatectomy with lymph-node dissection, fasting for \>12 hours before FEC-PET and an interval between biopsy and PET \>3 weeks.

Other: 18F-Ethylcholine Positron Emission Tomography (FEC-PET); Other: Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI)

Interventions

18F-Ethylcholine Positron Emission Tomography (FEC-PET) OTHER

PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a "cold" transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq \[18F\]Fluoroethylcholine chloride (FEC; Eckert \& Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. After a short gap due to computer processing time the whole body scan was performed starting at the upper thoracic aperture down to the proximal femur. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure.

1

Endorectal Magnetic Resonance Imaging (1.5Tesla) (eMRI) OTHER

The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2w spin echo (SE) sagittal, transversal and coronal sequences were acquired.

1

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically diagnosed prostate cancer (needle biopsy)
• Radical prostatectomy as primary treatment
• No nutrition within 12 hours before Positron-Emission-Tomography (PET)
• No food containing choline within 24 hous before PET
• Age \> 50 years

You may not qualify if:

• Total endo-prothesis of the hip region
• Clinical or chemical detection of an acute infection
• Missing patient agreement
• Secondary cancer
• Surgical treatment within 3 month before PET
• Claustrophobia
• Medical drugs with choline
• Severe liver damage
• Cardiac infarction
• Bradycardia (pulse rate \< 55/min)
• Allergic reaction against Neurotropan
• Bronchial asthma
• Cardiac pacemaker
• Small metal implants (e.g., clips, cochlea-implants, etc.)

Sponsors & Collaborators

• Dr. Markus Hartenbach: lead

Study Sites (1)

German Federal Armed Forces Hospital

Ulm, Baden-Wurttemberg, D 89081, Germany

Location

Related Publications (14)

• Robert-Koch-Institut (2010): Krebs in Deutschland 2005/2006 Häufigkeiten und Trends. A collaborative publication of the Robert-Koch-Institut and the Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V. [Society for epidemiological cancer register], 7th edition, Berlin.

  BACKGROUND

• Börgermann C, Rübben H (2006): Früherkennung des Prostatakarzinoms [Early recognition of prostate carcinoma]. Dtsch Arztebl. 103: 2399-2406.

  BACKGROUND

• Breslow N, Chan CW, Dhom G, Drury RA, Franks LM, Gellei B, Lee YS, Lundberg S, Sparke B, Sternby NH, Tulinius H. Latent carcinoma of prostate at autopsy in seven areas. The International Agency for Research on Cancer, Lyons, France. Int J Cancer. 1977 Nov 15;20(5):680-8. doi: 10.1002/ijc.2910200506.

  PMID: 924691 BACKGROUND

• de Jong IJ, Pruim J, Elsinga PH, Vaalburg W, Mensink HJ. Preoperative staging of pelvic lymph nodes in prostate cancer by 11C-choline PET. J Nucl Med. 2003 Mar;44(3):331-5.

  PMID: 12620996 BACKGROUND

• Deutsche Gesellschaft für Urologie (2009): Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms [Interdisciplinary guideline for the early recognition, diagnosis and therapy of the various stages of prostate carcinoma]. Deutsche Gesellschaft für Urologie e. V. (ed.), p. 53 ff.

  BACKGROUND

• FDA (2011): FDA clears new system to perform simultaneous PET, MRI scans. Available on-line at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2011/ucm258700.htm

  BACKGROUND

• Gauthier S, Diksic M, Yamamoto L, Tyler J, Feindel WH (1985): Positron emission tomography with [11C]-choline in human subjects. Can J Neurol Sci 12: 214.

  BACKGROUND

• Hara T, Kosaka N, Shinoura N, Kondo T. PET imaging of brain tumor with [methyl-11C]choline. J Nucl Med. 1997 Jun;38(6):842-7.

  PMID: 9189127 BACKGROUND

• Hara T, Kosaka N, Kishi H. PET imaging of prostate cancer using carbon-11-choline. J Nucl Med. 1998 Jun;39(6):990-5.

  PMID: 9627331 BACKGROUND

• Hara T, Kosaka N, Kishi H. Development of (18)F-fluoroethylcholine for cancer imaging with PET: synthesis, biochemistry, and prostate cancer imaging. J Nucl Med. 2002 Feb;43(2):187-99.

  PMID: 11850483 BACKGROUND

• Kwee SA, Coel MN, Lim J, Ko JP. Prostate cancer localization with 18fluorine fluorocholine positron emission tomography. J Urol. 2005 Jan;173(1):252-5. doi: 10.1097/01.ju.0000142099.80156.85.

  PMID: 15592091 BACKGROUND

• Pegios W, Bentas W, Wittmann L, Mack MG, Zangos S, Sollner O, Binder J, Fellbaum C, Jonas D, Vogl TJ. [MRI staging of prostate cancer with the combined endorectal body phased-array coil and histologic correlation]. Rofo. 2003 Dec;175(12):1660-6. doi: 10.1055/s-2003-45325. German.

  PMID: 14661137 BACKGROUND

• Porter CR, Kodama K, Gibbons RP, Correa R Jr, Chun FK, Perrotte P, Karakiewicz PI. 25-year prostate cancer control and survival outcomes: a 40-year radical prostatectomy single institution series. J Urol. 2006 Aug;176(2):569-74. doi: 10.1016/j.juro.2006.03.094.

  PMID: 16813891 BACKGROUND

• Yamaguchi T, Lee J, Uemura H, Sasaki T, Takahashi N, Oka T, Shizukuishi K, Endou H, Kubota Y, Inoue T. Prostate cancer: a comparative study of 11C-choline PET and MR imaging combined with proton MR spectroscopy. Eur J Nucl Med Mol Imaging. 2005 Jul;32(7):742-8. doi: 10.1007/s00259-004-1755-y. Epub 2005 Mar 15.

  PMID: 16052370 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Major Medical Corps Dr. Markus Hartenbach
• Organization: German Federal Armed Forces Hospital, Ulm

markushartenbach@bundeswehr.org

0049 731 1710 1851

Study Officials

• Markus Hartenbach, Dr.

  German Federal Armed Forces Hospital, Ulm, Dep. of Nuclear Medicine

  PRINCIPAL INVESTIGATOR

• Christoph Sparwasser, Prof. Dr.

  German Federal Armed Forces Hospital Ulm, Dep. of Urology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Major Medical Corps and assistant medical director of the nuclear medicine department

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 24, 2007
• Study Start: December 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 20, 2012
• Results First Posted: June 20, 2012

Record last verified: 2012-06

Locations

DE (1)