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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03982706
• Other study ID #: 0316-16-RMC
• Status: Enrolling by invitation
• Start date: October 28, 2015
• Est. completion date: June 6, 2020

Study information

• Verified date: August 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data.

The following information will be collected for all patients:

• Demographic data: date of birth, age, gender, ethnicity, Height, weight.

• Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests.

For patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected:

• MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values.

• Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable).

For patients who have undergone or are scheduled to undergo HIFU or Nano-Knife or Cryotherapy the following data will be collected:

• Procedure details.

• Evaluation of success: results of following PSA test, MRI and/or prostate biopsy.

Patients undergoing HIFU, Nano-Knife or Cryotherapy will also be asked to complete two questionnaires: IPSS, a validated lower urinary tract symptom questionnaire, and IIEF, a validated erectile function questionnaire.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: June 6, 2020
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

References & Publications (15)

Barzell WE, Melamed MR, Cathcart P, Moore CM, Ahmed HU, Emberton M. Identifying candidates for active surveillance: an evaluation of the repeat biopsy strategy for men with favorable risk prostate cancer. J Urol. 2012 Sep;188(3):762-7. doi: 10.1016/j.juro — View Citation

Blana A, Murat FJ, Walter B, Thuroff S, Wieland WF, Chaussy C, Gelet A. First analysis of the long-term results with transrectal HIFU in patients with localised prostate cancer. Eur Urol. 2008 Jun;53(6):1194-201. Epub 2007 Nov 5. — View Citation

Brown SB, Brown EA, Walker I. The present and future role of photodynamic therapy in cancer treatment. Lancet Oncol. 2004 Aug;5(8):497-508. Review. — View Citation

Kaplan 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. — View Citation

Kasivisvanathan V, Dufour R, Moore CM, Ahmed HU, Abd-Alazeez M, Charman SC, Freeman A, Allen C, Kirkham A, van der Meulen J, Emberton M. Transperineal magnetic resonance image targeted prostate biopsy versus transperineal template prostate biopsy in the d — View Citation

Klotz 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. — View Citation

Mearini L, D'Urso L, Collura D, Nunzi E, Muto G, Porena M. High-intensity focused ultrasound for the treatment of prostate cancer: A prospective trial with long-term follow-up. Scand J Urol. 2015;49(4):267-74. doi: 10.3109/21681805.2014.988174. Epub 2014 — View Citation

Pinto 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/ultrasoun — View Citation

Shaw GL, Thomas BC, Dawson SN, Srivastava G, Vowler SL, Gnanapragasam VJ, Shah NC, Warren AY, Neal DE. Identification of pathologically insignificant prostate cancer is not accurate in unscreened men. Br J Cancer. 2014 May 13;110(10):2405-11. doi: 10.1038 — View Citation

Siegel 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. Erratum in: CA Cancer J Clin. 2014 Sep-Oct;64(5):364. — View Citation

Sonn 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.2 — View Citation

Valerio M, Dickinson L, Ali A, Ramachadran N, Donaldson I, Mccartan N, Freeman A, Ahmed HU, Emberton M. Nanoknife Electroporation Ablation Trial: A Prospective Development Study Investigating Focal Irreversible Electroporation for Localized Prostate Cance — View Citation

Valerio M, Dickinson L, Ali A, Ramachandran N, Donaldson I, Freeman A, Ahmed HU, Emberton M. A prospective development study investigating focal irreversible electroporation in men with localised prostate cancer: Nanoknife Electroporation Ablation Trial ( — View Citation

Wise 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. — View Citation

Wysock JS, Rosenkrantz AB, Huang WC, Stifelman MD, Lepor H, Deng FM, Melamed J, Taneja SS. A prospective, blinded comparison of magnetic resonance (MR) imaging-ultrasound fusion and visual estimation in the performance of MR-targeted prostate biopsy: the — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA change after focal therapy (HIFU, Nano-Knife and Cryotherapy)	PSA will be taken every 3 months during the first year after procedure, and every 6 months in the next following 4 years	5 years
Primary	Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy.	clinically significant prostate cancer is defined as Gleason 7 and above	5 years
Secondary	Change in urinary symptoms measured by International Prostate Symptom Score (IPSS) questioner	IPSS questioner is a validated tool to assess urinary symptoms. Total score is ranged 0-35. Lower values represent a better outcome.; IPSS will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure	5 years
Secondary	Change in erectile function measured by International Index of Erectile Function (IIEF-5) questioner	IIEF-5 questioner is a validated tool to assess erectile function in men. Total score is ranged 1-25. Higher values represent a better outcome.; IIEF-5 will be filled before the procedure, every three months during the first year and every six months during the next four years following the procedure	5 years