Clinical trial · Observational

Examination of Focal Therapies- MRI-Fusion, HIFU, NanoKnife and Cryotherapy

Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy

NCT03982706CI-TRIAL-00039065unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The main objective of this study is to determine whether focal-driven therapies for diagnosis and treatment of prostate cancer are preferable over current clinical methods. Different focal procedures will be examined, including magnetic resonance imaging (MRI)-target biopsy, and focal treatment as High Intensity Focused Ultrasound (HIFU), cryoablation and Nano-Knife.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
MRI-US Fusion
description
patients undergoing MRI targeted prostate biopsy
label
Focal
description
patients undergoing focal treatment for localized prostate cancer (HIFU, NanoKnife, Cryotherapy)

Primary outcomes (2)

measure
PSA change after focal therapy (HIFU, Nano-Knife and Cryotherapy)
timeFrame
5 years
description
PSA will be taken every 3 months during the first year after procedure, and every 6 months in the next following 4 years
measure
Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy.
timeFrame
5 years
description

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years
Maximum age: 90 Years

Show eligibility criteria text

Inclusion Criteria:

1. Men who have underwent, or are scheduled to undergo a focal therapy treatment at Ramat Aviv Medical Center or Rabin Medical Center
2. Age 18-90.

Exclusion Criteria:

None.

References

Publications (15)

BACKGROUNDSiegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7. PMID 24399786
BACKGROUNDKaplan I, Oldenburg NE, Meskell P, Blake M, Church P, Holupka EJ. Real time MRI-ultrasound image guided stereotactic prostate biopsy. Magn Reson Imaging. 2002 Apr;20(3):295-9. doi: 10.1016/s0730-725x(02)00490-3. PMID 12117612
BACKGROUNDBrown SB, Brown EA, Walker I. The present and future role of photodynamic therapy in cancer treatment. Lancet Oncol. 2004 Aug;5(8):497-508. doi: 10.1016/S1470-2045(04)01529-3. PMID 15288239
RESULTKlotz L, Zhang L, Lam A, Nam R, Mamedov A, Loblaw A. Clinical results of long-term follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol. 2010 Jan 1;28(1):126-31. doi: 10.1200/JCO.2009.24.2180. Epub 2009 Nov 16. PMID 19917860
RESULTWise AM, Stamey TA, McNeal JE, Clayton JL. Morphologic and clinical significance of multifocal prostate cancers in radical prostatectomy specimens. Urology. 2002 Aug;60(2):264-9. doi: 10.1016/s0090-4295(02)01728-4. PMID 12137824
RESULTPinto PA, Chung PH, Rastinehad AR, Baccala AA Jr, Kruecker J, Benjamin CJ, Xu S, Yan P, Kadoury S, Chua C, Locklin JK, Turkbey B, Shih JH, Gates SP, Buckner C, Bratslavsky G, Linehan WM, Glossop ND, Choyke PL, Wood BJ. Magnetic resonance imaging/ultrasound fusion guided prostate biopsy improves cancer detection following transrectal ultrasound biopsy and correlates with multiparametric magnetic resonance imaging. J Urol. 2011 Oct;186(4):1281-5. doi: 10.1016/j.juro.2011.05.078. Epub 2011 Aug 17. PMID 21849184
RESULTSonn GA, Natarajan S, Margolis DJ, MacAiran M, Lieu P, Huang J, Dorey FJ, Marks LS. Targeted biopsy in the detection of prostate cancer using an office based magnetic resonance ultrasound fusion device. J Urol. 2013 Jan;189(1):86-91. doi: 10.1016/j.juro.2012.08.095. Epub 2012 Nov 14.